Listing of approvals

View the lists of therapeutic products approvals and new indications approved for registered therapeutic products.

Last updated 2 September 2026

For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.

New Drug Applications (NDA)

Please click here for a list of summary reports of benefit-risk assessments.
Please click here for description of application types.

NDAs approved in July 2026

Product Name	Product Information
BLENREP POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 70MG/VIAL AND 100 MG/ VIAL (SIN17590P, SIN17592P)	Active Ingredient(s): Belantamab mafodotin(70mg and 100mg/ vial)
	Application Type: NDA-1, NDA-3
	Product Registrant: GLAXOSMITHKLINE PTE LTD
	Approval Date: 21/07/2026
FORTISSO SOLUTION FOR INJECTION 120 MG/VIAL (SIN17594P)	Active Ingredient(s): Denosumab(120 mg/vial)
	Application Type: NDA-2: Biosimilar
	Product Registrant: LOTUS INTERNATIONAL PTE. LTD.
	Approval Date: 21/07/2026
OSIFOR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 60 MG/ML (SIN17593P)	Active Ingredient(s): Denosumab(60 mg/mL)
	Application Type: NDA-2: Biosimilar
	Product Registrant: LOTUS INTERNATIONAL PTE. LTD.
	Approval Date: 21/07/2026
CAMCEVI PROLONGED-RELEASE SUSPENSION FOR INJECTION 42 MG PER SYRINGE (SIN17580P)	Active Ingredient(s): Leuprorelin mesilate eqv to leuprorelin(42 mg/ syringe)
	Application Type: NDA-2
	Product Registrant: GENSCI SINGAPORE PTE. LTD.
	Approval Date: 08/07/2026
PANZYGA SOLUTION FOR INFUSION 100MG/ML (SIN17579P)	Active Ingredient(s): Human Normal Immunoglobulin(100mg/ml)
	Application Type: NDA-2
	Product Registrant: WELLCHEM PHARMACEUTICALS PTE LTD
	Approval Date: 08/07/2026
TARLIGE FILM-COATED TABLET 2.5 MG, 5 MG, 10 MG, 15 MG (SIN17575P, SIN17574P, SIN17577P, SIN17576P)	Active Ingredient(s): MIROGABALIN BESILATE eqv. MIROGABALIN(2.5 mg, 5 mg, 10 mg, 15 mg)
	Application Type: NDA-1, NDA-3
	Product Registrant: A. MENARINI SINGAPORE PTE. LTD.
	Approval Date: 06/07/2026

NDAs approved in June 2026

Product Name	Product Information
YESINTEK CONCENTRATE FOR SOLUTION FOR INFUSION 130MG/26ML (SIN17571P)	Active Ingredient(s): Ustekinumab(130mg/26mL)
	Application Type: NDA-2: Biosimilar
	Product Registrant: CEDAR PHARMACEUTICALS PTE. LTD.
	Approval Date: 26/06/2026
YESINTEK SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 45MG/0.5ML (SIN17569P)	Active Ingredient(s): Ustekinumab(45mg/0.5mL)
	Application Type: NDA-2: Biosimilar
	Product Registrant: CEDAR PHARMACEUTICALS PTE. LTD.
	Approval Date: 26/06/2026
YESINTEK SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 90MG/1ML (SIN17570P)	Active Ingredient(s): Ustekinumab(90mg/1mL)
	Application Type: NDA-3: Biosimilar
	Product Registrant: CEDAR PHARMACEUTICALS PTE. LTD.
	Approval Date: 26/06/2026
EVFRAXY SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 60MG/ML (SIN17564P)	Active Ingredient(s): Denosumab(60mg/mL)
	Application Type: NDA-2: Biosimilar
	Product Registrant: CEDAR PHARMACEUTICALS PTE. LTD.
	Approval Date: 23/06/2026
VEVZUO SOLUTION FOR INJECTION 120MG/1.7ML (SIN17563P)	Active Ingredient(s): Denosumab(120mg/1.7mL)
	Application Type: NDA-2: Biosimilar
	Product Registrant: CEDAR PHARMACEUTICALS PTE. LTD.
	Approval Date: 23/06/2026
APHEXDA LYOPHILIZED POWDER FOR SOLUTION FOR INJECTION 62 MG/VIAL (SIN17555P)	Active Ingredient(s): Motixafortide acetate eqv Motixafortide(62mg/vial)
	Application Type: NDA-1
	Product Registrant: DCH AURIGA SINGAPORE
	Approval Date: 08/06/2026
ICHALIG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 45MG/0.5ML (SIN17553P)	Active Ingredient(s): Ustekinumab(45mg/0.5ml)
	Application Type: NDA-2: Biosimilar
	Product Registrant: SINDOR HEALTHCARE PTE. LTD.
	Approval Date: 04/06/2026

NDAs approved in May 2026

Product Name	Product Information
USTEFAV SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 45MG/0.5ML (SIN17541P)	Active Ingredient(s): Ustekinumab(45mg/ 0.5ml)
	Application Type: NDA-2: Biosimilar
	Product Registrant: HYPHENS PHARMA PTE. LTD.
	Approval Date: 21/05/2026
USTEFAV SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 90MG/1ML (SIN17542P)	Active Ingredient(s): Ustekinumab(90mg/1ml)
	Application Type: NDA-3: Biosimilar
	Product Registrant: HYPHENS PHARMA PTE. LTD.
	Approval Date: 21/05/2026
TEPEZZA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 500 MG/VIAL (SIN17539P)	Active Ingredient(s): Teprotumumab(500 mg/vial)
	Application Type: NDA-1
	Product Registrant: AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD
	Approval Date: 15/05/2026

NDAs approved in Jan - Apr 2026

Product Name	Product Information
LUMAKRAS FILM-COATED TABLET 240MG (SIN17527P)	Active Ingredient(s): Sotorasib(240mg)
	Application Type: NDA-3
	Product Registrant: AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD
	Approval Date: 28/04/2026
VERDYE POWDER FOR SOLUTION FOR INJECTION 25 MG/VIAL (SIN17525P)	Active Ingredient(s): Indocyanine Green(25 mg/vial)
	Application Type: NDA-1
	Product Registrant: TRANSMEDIC PTE LTD
	Approval Date: 27/04/2026
FIRAZYR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 30MG/3ML (SIN17516P)	Active Ingredient(s): Icatibant acetate eqv icatibant(30 mg/3mL)
	Application Type: NDA-1
	Product Registrant: TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
	Approval Date: 15/04/2026
CREON 25000 CAPSULE, COATED PELLETS 300MG (SIN17515P)	Active Ingredient(s): PANCREAS POWDER(300mg)
	Application Type: NDA-3
	Product Registrant: ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
	Approval Date: 10/04/2026
TAKHZYRO SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 150MG/ML (SIN17510P)	Active Ingredient(s): Lanadelumab(150mg/mL)
	Application Type: NDA-2
	Product Registrant: TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
	Approval Date: 01/04/2026
TAKHZYRO SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 300MG/2ML (SIN17511P)	Active Ingredient(s): Lanadelumab(300mg/2mL)
	Application Type: NDA-1
	Product Registrant: TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
	Approval Date: 01/04/2026
STREPSILS MAX PRO DIRECT SPRAY HONEY AND LEMON 8.75MG PER DOSE (SIN17495P)	Active Ingredient(s): Flurbiprofen(8.748mg/dose)
	Application Type: NDA-2
	Product Registrant: RECKITT BENCKISER (SINGAPORE) PTE LTD
	Approval Date: 24/03/2026
DIFFLAM PLUS ANAESTHETIC SORE THROAT SPRAY (SIN17493P)	Active Ingredient(s): 2,4 Dichlorobenzyl alcohol(338 mcg/spray),Benzydamine hydrochloride(390 mcg/spray),Lidocaine hydrochloride monohydrate(559 mcg/spray)
	Application Type: NDA-2
	Product Registrant: INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED
	Approval Date: 23/03/2026
TANSTRIVE TABLETS 80MG (SIN17488P)	Active Ingredient(s): Selpercatinib(80mg)
	Application Type: NDA-3
	Product Registrant: DKSH SINGAPORE PTE. LTD.
	Approval Date: 19/03/2026
TANSTRIVE TABLETS 40MG (SIN17487P)	Active Ingredient(s): Selpercatinib(40mg)
	Application Type: NDA-2
	Product Registrant: DKSH SINGAPORE PTE. LTD.
	Approval Date: 19/03/2026
EVRYSDI FILM-COATED TABLET 5MG (SIN17484P)	Active Ingredient(s): Risdiplam(5.000 mg)
	Application Type: NDA-2
	Product Registrant: ROCHE SINGAPORE PTE. LTD.
	Approval Date: 16/03/2026
TIBSOVO FILM-COATED TABLET 250MG (SIN17485P)	Active Ingredient(s): Ivosidenib(250.0mg)
	Application Type: NDA-1
	Product Registrant: SERVIER (S) PTE LTD
	Approval Date: 16/03/2026
MRESVIA DISPERSION FOR INJECTION IN PRE-FILLED SYRINGE 50MCG/0.5ML (SIN17482P)	Active Ingredient(s): RNA-100-AR02 (mRNA-1345 encoding RSV F glycoprotein in prefusion conformation)(0.050mg/0.5ml dose)
	Application Type: NDA-1
	Product Registrant: MODERNA BIOTECH SINGAPORE PTE. LTD.
	Approval Date: 06/03/2026
CAPVAXIVE SOLUTION FOR INJECTION (SIN17471P)	Active Ingredient(s): (MBC) Pneumococcal Polysaccharide Serotype 10A conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 11A conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 12F conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 15A conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 16F conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 17F conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 19A conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 20A conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 22F conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 23A conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 23B conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 24F conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 3 conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 31 conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 33F conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 35B conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 6A conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 7F conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 8 conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 9N conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide de-O-acetylated Serotype 15B conjugated to CRM197(4ug/0.5mL)
	Application Type: NDA-1
	Product Registrant: MSD PHARMA (SINGAPORE) PTE. LTD.
	Approval Date: 20/02/2026
FLUARIX SUSPENSION FOR INJECTION (SIN17468P)	Active Ingredient(s): Influenza Virus (NH) A/Thailand/8/2022 (H3N2)-like strain(15 μg Haemagglutinin/ 0.5 mL),Influenza Virus (NH) A/Victoria/4897/2022 (H1N1)pdm09-like strain(15 μg Haemagglutinin/ 0.5 mL),Influenza Virus (NH) B/Austria/1359417/2021-like strain(15 μg Haemagglutinin/ 0.5 mL)
	Application Type: NDA-2
	Product Registrant: GLAXOSMITHKLINE PTE LTD
	Approval Date: 13/02/2026
ENFLONSIA™ SOLUTION FOR INJECTION 105MG/0.7ML IN PRE-FILLED SYRINGE (SIN17467P) * Evaluated via Access	Active Ingredient(s): Clesrovimab(105mg/0.7mL)
	Application Type: NDA-1
	Product Registrant: MSD PHARMA (SINGAPORE) PTE. LTD.
	Approval Date: 12/02/2026
ADACEL, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 0.5 ML (SIN17460P)	Active Ingredient(s): (Acellular Pertussis) FilamentousHaemagglutinin Adsorbed (FHA)(5 μg/ 0.5mL),(Acellular Pertussis) Fimbriae Type 2 and 3Adsorbed (FIM)(5 μg/ 0.5mL),(Acellular Pertussis) Pertactin Adsorbed (PRN)(3 μg/ 0.5mL),(Acelullar Pertussis) Pertussis ToxoidAdsorbed (PT)(2.5 μg/ 0.5mL),Diphtheria Toxoid Adsorbed(2 LF/ 0.5mL),Tetanus Toxoid Adsorbed(5 LF/ 0.5mL)
	Application Type: NDA-2
	Product Registrant: SANOFI-AVENTIS SINGAPORE PTE. LTD.
	Approval Date: 09/02/2026
EMBLAVEO POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 1.5G/0.5G (SIN17438P) * Evaluated via ASEAN Joint review	Active Ingredient(s): Avibactam Sodium eqv Avibactam(0.5 g/vial ),Aztreonam(1.5 g/vial)
	Application Type: NDA-2
	Product Registrant: PFIZER PRIVATE LIMITED
	Approval Date: 15/01/2026
JUBBONTI SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 60MG/ML (SIN17439P)	Active Ingredient(s): Denosumab(60 mg/ml)
	Application Type: NDA-2: Biosimilar
	Product Registrant: SANDOZ SINGAPORE PTE. LTD.
	Approval Date: 15/01/2026
WYOST SOLUTION FOR INJECTION 120MG/1.7ML (SIN17440P)	Active Ingredient(s): Denosumab(120 mg/1.7ml)
	Application Type: NDA-2: Biosimilar
	Product Registrant: SANDOZ SINGAPORE PTE. LTD.
	Approval Date: 15/01/2026
VALTOCO NASAL SPRAY 10MG/SPRAY (SIN17435P)	Active Ingredient(s): Diazepam(10mg/spray)
	Application Type: NDA-2
	Product Registrant: RXILIENT MEDICAL PTE LTD
	Approval Date: 14/01/2026
VALTOCO NASAL SPRAY 5MG/SPRAY (SIN17437P)	Active Ingredient(s): Diazepam(5.00mg/spray)
	Application Type: NDA-3
	Product Registrant: RXILIENT MEDICAL PTE LTD
	Approval Date: 14/01/2026
VALTOCO NASAL SPRAY 7.5MG/SPRAY (SIN17436P)	Active Ingredient(s): Diazepam(7.5mg/ spray)
	Application Type: NDA-3
	Product Registrant: RXILIENT MEDICAL PTE LTD
	Approval Date: 14/01/2026
FRAGMIN SOLUTION FOR INJECTION PREFILLED SYRINGE 2500 IU/0.2 ML (SIN17433P)	Active Ingredient(s): Dalteparin Sodium(2500 IU/0.2ml)
	Application Type: NDA-2
	Product Registrant: PFIZER PRIVATE LIMITED
	Approval Date: 13/01/2026
FRAGMIN SOLUTION FOR INJECTION PREFILLED SYRINGE 5000 IU/0.2 ML (SIN17434P)	Active Ingredient(s): Dalteparin Sodium(5000 IU/0.2ml)
	Application Type: NDA-3
	Product Registrant: PFIZER PRIVATE LIMITED
	Approval Date: 13/01/2026
PAXLOVID (NIRMATRELVIR AND RITONAVIR) FILM-COATED TABLETS (SIN17428P)	Active Ingredient(s): Nirmatrelvir(150 mg),Ritonavir(100 mg)
	Application Type: NDA-2
	Product Registrant: PFIZER PRIVATE LIMITED
	Approval Date: 07/01/2026

Click here to view older listings of new drug approvals

Generic Drug Applications (GDA)

List of GDAs approved in July 2026

Product Name	Product Information
K-DENT INJECTION (SIN17599P)	Active Ingredient(s): Epinephrine Bitartrate eqv Epinephrine(0.01 mg/ml),Lidocaine Hydrochloride(20 mg/ml)
	Application Type: GDA-1
	Product Registrant: MARTHA TRADE PTE. LTD
	Approval Date: 31/07/2026
TERISUN SOLUTION FOR INJECTION IN PRE-FILLED PEN 20MCG/80MCL (SIN17603P)	Active Ingredient(s): Teriparatide(20mcg/80mcl)
	Application Type: GDA-1
	Product Registrant: RANBAXY (MALAYSIA) SDN. BHD.
	Approval Date: 31/07/2026
VALSOON FILM COATED TABLETS 5MG/160MG (SIN17598P)	Active Ingredient(s): Amlodipine Besylate eqv to Amlodipine( 5 mg ),Valsartan(160 mg)
	Application Type: GDA-1
	Product Registrant: NOVEM HEALTHCARE PTE LTD
	Approval Date: 31/07/2026
XARID 20 RIVAROXABAN TABLETS PH.EUR. 20MG (SIN17600P)	Active Ingredient(s): Rivaroxaban(20mg)
	Application Type: GDA-1
	Product Registrant: ZYFAS PHARMA PTE LTD
	Approval Date: 31/07/2026
XARID 15 RIVAROXABAN TABLETS PH.EUR. 15MG (SIN17601P)	Active Ingredient(s): Rivaroxaban(15mg)
	Application Type: GDA-2
	Product Registrant: ZYFAS PHARMA PTE LTD
	Approval Date: 31/07/2026
XARID 10 RIVAROXABAN TABLETS PH.EUR. 10MG (SIN17602P)	Active Ingredient(s): Rivaroxaban(10mg)
	Application Type: GDA-2
	Product Registrant: ZYFAS PHARMA PTE LTD
	Approval Date: 31/07/2026
NITROMINT SUBLINGUAL SPRAY 400MCG/SPRAY (SIN17597P)	Active Ingredient(s): Glyceryl Trinitrate(400mcg/spray)
	Application Type: GDA-1
	Product Registrant: JOYSON PTE. LTD.
	Approval Date: 31/07/2026
DEFEROX FILM-COATED TABLETS 360MG (SIN17596P)	Active Ingredient(s): Deferasirox(360 mg)
	Application Type: GDA-1
	Product Registrant: CHEMKRAFT PTE. LTD.
	Approval Date: 30/07/2026
DEFEROX FILM-COATED TABLETS 90MG (SIN17595P)	Active Ingredient(s): Deferasirox(90 mg)
	Application Type: GDA-2
	Product Registrant: CHEMKRAFT PTE. LTD.
	Approval Date: 30/07/2026
PALONOSETRON KABI SOLUTION FOR INJECTION 50MCG/ML (SIN17591P)	Active Ingredient(s): Palonosetron Hydrochloride eqv Palonosetron(50mcg/ml)
	Application Type: GDA-1
	Product Registrant: FRESENIUS KABI (SINGAPORE) PTE LTD
	Approval Date: 21/07/2026
XAFARIV FILM-COATED TABLETS 10 MG (SIN17587P)	Active Ingredient(s): Rivaroxaban(10.000 mg)
	Application Type: GDA-2
	Product Registrant: VIATRIS PRIVATE LIMITED
	Approval Date: 14/07/2026
XAFARIV FILM-COATED TABLETS 20 MG (SIN17589P)	Active Ingredient(s): Rivaroxaban(20.000 mg)
	Application Type: GDA-2
	Product Registrant: VIATRIS PRIVATE LIMITED
	Approval Date: 14/07/2026
XAFARIV FILM-COATED TABLETS 15 MG (SIN17588P)	Active Ingredient(s): Rivaroxaban(15.000 mg)
	Application Type: GDA-2
	Product Registrant: VIATRIS PRIVATE LIMITED
	Approval Date: 14/07/2026
XAFARIV FILM-COATED TABLETS 2.5 MG (SIN17586P)	Active Ingredient(s): Rivaroxaban(2.500 mg)
	Application Type: GDA-1
	Product Registrant: VIATRIS PRIVATE LIMITED
	Approval Date: 14/07/2026
EVEROLIMUS BIOCON TABLETS 0.75MG (SIN17584P)	Active Ingredient(s): Everolimus(0.75mg)
	Application Type: GDA-2
	Product Registrant: TAEVAS LIFE SCIENCES PTE LTD
	Approval Date: 14/07/2026
SEVAMER - SEVELAMER CARBONATE FILM COATED TABLETS 800 MG (SIN17585P)	Active Ingredient(s): Sevelamer Carbonate(800 mg)
	Application Type: GDA-1
	Product Registrant: STRIDES PHARMA GLOBAL PTE. LIMITED
	Approval Date: 14/07/2026
EVEROLIMUS BIOCON TABLETS 0.25MG (SIN17583P)	Active Ingredient(s): Everolimus(0.25 mg)
	Application Type: GDA-1
	Product Registrant: TAEVAS LIFE SCIENCES PTE LTD
	Approval Date: 13/07/2026
EPHEDRINE-AFT SOLUTION FOR INJECTION 30MG/ML (SIN17581P)	Active Ingredient(s): Ephedrine HCL eqv Ephedrine(30mg)
	Application Type: GDA-1
	Product Registrant: APEX PHARMA MARKETING PTE. LTD.
	Approval Date: 10/07/2026
MILRINONE-EMCURE CONCENTRATE FOR SOLUTION FOR INJECTION 10MG/10ML (SIN17582P)	Active Ingredient(s): Milrinone lactate eqv Milrinone(10mg per 10ml)
	Application Type: GDA-1
	Product Registrant: ADVAGEN PTE. LTD.
	Approval Date: 10/07/2026
LAX-TAB SENNA TABLET 7.5MG (SIN17578P)	Active Ingredient(s): Calcium Sennosides 20% eqv Sennoside B(7.5mg)
	Application Type: GDA-1
	Product Registrant: APEX PHARMA MARKETING PTE. LTD.
	Approval Date: 08/07/2026
DR. REDDY'S SITAGLIPTIN TABLETS USP 100MG (SIN17573P)	Active Ingredient(s): SITAGLIPTIN PHOSPHATE ANHYDROUS EQV SITAGLIPTIN(100 MG)
	Application Type: GDA-1
	Product Registrant: ZYFAS PHARMA PTE LTD
	Approval Date: 06/07/2026
MYBORTE POWDER FOR SOLUTION FOR INJECTION 3.5MG/VIAL (SIN17572P)	Active Ingredient(s): Bortezomib(3.5mg/vial)
	Application Type: GDA-1
	Product Registrant: ZYFAS PHARMA PTE LTD
	Approval Date: 01/07/2026

List of GDAs approved in June 2026

Product Name	Product Information
PANTOPRAZOLE AUXILTO POWDER FOR SOLUTION FOR INJECTION 40MG/VIAL (SIN17568P)	Active Ingredient(s): Pantoprazole Sodium Sesquihydrate eqv. Pantoprazole(40 mg /vial)
	Application Type: GDA-1
	Product Registrant: AUXILTO IMPEX PTE. LTD.
	Approval Date: 26/06/2026
SITAGLIPTIN CHEMKRAFT FILM-COATED TABLETS 50 MG (SIN17566P)	Active Ingredient(s): Sitagliptin phosphate monohydrate eqv Sitagliptin(50 mg)
	Application Type: GDA-2
	Product Registrant: CHEMKRAFT PTE. LTD.
	Approval Date: 24/06/2026
SITAGLIPTIN CHEMKRAFT FILM-COATED TABLETS 100 MG (SIN17567P)	Active Ingredient(s): Sitagliptin phosphate monohydrate eqv Sitagliptin(100 mg)
	Application Type: GDA-1
	Product Registrant: CHEMKRAFT PTE. LTD.
	Approval Date: 24/06/2026
SITAGLIPTIN CHEMKRAFT FILM-COATED TABLETS 25 MG (SIN17565P)	Active Ingredient(s): Sitagliptin phosphate monohydrate eqv Sitagliptin(25 mg)
	Application Type: GDA-2
	Product Registrant: CHEMKRAFT PTE. LTD.
	Approval Date: 24/06/2026
SITAGLIPTIN ADAMED FILM-COATED TABLETS 25 MG (SIN17562P)	Active Ingredient(s): Sitagliptin hydrochloride monohydrate eqv to Sitagliptin(25mg)
	Application Type: GDA-2
	Product Registrant: DKSH SINGAPORE PTE. LTD.
	Approval Date: 15/06/2026
SITAGLIPTIN ADAMED FILM-COATED TABLETS 100 MG (SIN17560P)	Active Ingredient(s): Sitagliptin hydrochloride monohydrate eqv to Sitagliptin(100mg)
	Application Type: GDA-1
	Product Registrant: DKSH SINGAPORE PTE. LTD.
	Approval Date: 15/06/2026
SITAGLIPTIN ADAMED FILM-COATED TABLETS 50 MG (SIN17561P)	Active Ingredient(s): Sitagliptin hydrochloride monohydrate eqv to Sitagliptin(50mg)
	Application Type: GDA-2
	Product Registrant: DKSH SINGAPORE PTE. LTD.
	Approval Date: 15/06/2026
RENAXIN FILM-COATED TABLETS 5MG (SIN17559P)	Active Ingredient(s): Solifenacin Succinate(5 mg )
	Application Type: GDA-1
	Product Registrant: SEA PHARMA CONSULTANCY PTE LTD
	Approval Date: 11/06/2026
GANIRELIX-AFT SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 0.25 MG/0.5 ML (SIN17558P)	Active Ingredient(s): Ganirelix Acetate eqv. Ganirelix(0.25mg/0.5 mL)
	Application Type: GDA-1
	Product Registrant: APEX PHARMA MARKETING PTE. LTD.
	Approval Date: 11/06/2026
BISOPROLOL-AFT FILM COATED TABLET 5MG (SIN17557P)	Active Ingredient(s): BISOPROLOL FUMARATE(5mg)
	Application Type: GDA-1
	Product Registrant: APEX PHARMA MARKETING PTE. LTD.
	Approval Date: 10/06/2026
BYLASTIN TABLET 20MG (SIN17556P)	Active Ingredient(s): Bilastine(20.0mg)
	Application Type: GDA-1
	Product Registrant: MIRACO NUTRIPHARM PTE. LTD.
	Approval Date: 08/06/2026
ENZALUTAMIDE-TEVA SOFT CAPSULES 40MG (SIN17554P)	Active Ingredient(s): Enzalutamide(40 mg)
	Application Type: GDA-1
	Product Registrant: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
	Approval Date: 05/06/2026
HENGRUI IODIXANOL SOLUTION FOR INJECTION 270 MG I/ML (SIN17550P)	Active Ingredient(s): Iodixanol 550 mg eqv Iodine(270 mg/mL)
	Application Type: GDA-1
	Product Registrant: HENGRUI SG PTE. LTD.
	Approval Date: 03/06/2026
HENGRUI IODIXANOL SOLUTION FOR INJECTION 320 MG I/ML (SIN17551P)	Active Ingredient(s): Iodixanol 652 mg eqv Iodine(320 mg/mL)
	Application Type: GDA-2
	Product Registrant: HENGRUI SG PTE. LTD.
	Approval Date: 03/06/2026
ELHIST 20 TABLETS 20MG (SIN17552P)	Active Ingredient(s): Bilastine(20 mg)
	Application Type: GDA-1
	Product Registrant: UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
	Approval Date: 03/06/2026

List of GDAs approved in May 2026

Product Name	Product Information
OCTRA SOLUTION FOR INJECTION 0.1 MG/ML (SIN17549P)	Active Ingredient(s): Octreotide acetate eqv Octreotide(0.1 mg/ml )
	Application Type: GDA-1
	Product Registrant: GOLDPLUS UNIVERSAL PTE LTD
	Approval Date: 28/05/2026
EMPAZOX 25 EMPAGLIFLOZIN FILM COATED TABLETS 25 MG (SIN17547P)	Active Ingredient(s): Empagliflozin(25.000 mg)
	Application Type: GDA-1
	Product Registrant: HETERO SINGAPORE PTE. LTD.
	Approval Date: 26/05/2026
EMPAZOX 10 EMPAGLIFLOZIN FILM COATED TABLETS 10 MG (SIN17548P)	Active Ingredient(s): Empagliflozin(10.000 mg)
	Application Type: GDA-2
	Product Registrant: HETERO SINGAPORE PTE. LTD.
	Approval Date: 26/05/2026
LEVETROY CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/ ML (SIN17546P)	Active Ingredient(s): Levetiracetam(100 mg/ml)
	Application Type: GDA-1
	Product Registrant: SIXMURS SINGAPORE PTE. LTD.
	Approval Date: 25/05/2026
ARIPIPRAZOLE CHEMKRAFT TABLETS 10 MG (SIN17544P)	Active Ingredient(s): Aripiprazole(10.00 mg)
	Application Type: GDA-2
	Product Registrant: CHEMKRAFT PTE. LTD.
	Approval Date: 21/05/2026
ARIPIPRAZOLE CHEMKRAFT TABLETS 15 MG (SIN17543P)	Active Ingredient(s): Aripiprazole(15.00 mg)
	Application Type: GDA-1
	Product Registrant: CHEMKRAFT PTE. LTD.
	Approval Date: 21/05/2026
ARIPIPRAZOLE CHEMKRAFT TABLETS 30 MG (SIN17545P)	Active Ingredient(s): Aripiprazole(30.00 mg)
	Application Type: GDA-2
	Product Registrant: CHEMKRAFT PTE. LTD.
	Approval Date: 21/05/2026
PACXIB POWDER FOR SOLUTION FOR INJECTION 40MG/VIAL (SIN17540P)	Active Ingredient(s): Parecoxib Sodium eqv Parecoxib(40 mg/vial)
	Application Type: GDA-1
	Product Registrant: NOVEM HEALTHCARE PTE LTD
	Approval Date: 19/05/2026
GEMCITABINE-TEVA CONCENTRATE FOR SOLUTION FOR INFUSION 40MG/ML (SIN17538P)	Active Ingredient(s): Gemcitabine Hydrochloride equivalent to Gemcitabine(40mg/ml)
	Application Type: GDA-1
	Product Registrant: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
	Approval Date: 13/05/2026
ORANXA 10 RIVAROXABAN FILM-COATED TABLETS BP 10MG (SIN17536P)	Active Ingredient(s): Rivaroxaban(10mg)
	Application Type: GDA-2
	Product Registrant: RANBAXY (MALAYSIA) SDN. BHD.
	Approval Date: 08/05/2026
ORANXA 15 RIVAROXABAN FILM-COATED TABLETS BP 15MG (SIN17535P)	Active Ingredient(s): Rivaroxaban(15mg)
	Application Type: GDA-2
	Product Registrant: RANBAXY (MALAYSIA) SDN. BHD.
	Approval Date: 08/05/2026
ORANXA 20 RIVAROXABAN FILM-COATED TABLETS BP 20MG (SIN17537P)	Active Ingredient(s): Rivaroxaban(20mg)
	Application Type: GDA-1
	Product Registrant: RANBAXY (MALAYSIA) SDN. BHD.
	Approval Date: 08/05/2026
JBRIVO FILM-COATED TABLET 20 MG (SIN17530P)	Active Ingredient(s): Rivaroxaban(20.00 mg)
	Application Type: GDA-1
	Product Registrant: UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
	Approval Date: 06/05/2026
JBRIVO FILM-COATED TABLET 15 MG (SIN17529P)	Active Ingredient(s): Rivaroxaban(15.00 mg)
	Application Type: GDA-2
	Product Registrant: UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
	Approval Date: 06/05/2026
LYO-DROL POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 40MG/VIAL (SIN17532P)	Active Ingredient(s): METHYLPREDNISOLONE HYDROGEN SUCCINATE EQV METHYLPREDNISOLONE(40mg/vial)
	Application Type: GDA-2
	Product Registrant: TRANET HOLDINGS PTE LTD
	Approval Date: 06/05/2026
LYO-DROL POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 125MG/VIAL (SIN17533P)	Active Ingredient(s): METHYLPREDNISOLONE HYDROGEN SUCCINATE EQV METHYLPREDNISOLONE(125mg/vial)
	Application Type: GDA-2
	Product Registrant: TRANET HOLDINGS PTE LTD
	Approval Date: 06/05/2026
JBRIVO FILM-COATED TABLET 10 MG (SIN17528P)	Active Ingredient(s): Rivaroxaban(10 mg)
	Application Type: GDA-2
	Product Registrant: UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
	Approval Date: 06/05/2026
LYO-DROL POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 1000MG/VIAL (SIN17534P)	Active Ingredient(s): METHYLPREDNISOLONE HYDROGEN SUCCINATE EQV METHYLPREDNISOLONE(1000mg/vial)
	Application Type: GDA-2
	Product Registrant: TRANET HOLDINGS PTE LTD
	Approval Date: 06/05/2026
LYO-DROL POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 500MG/VIAL (SIN17531P)	Active Ingredient(s): METHYLPREDNISOLONE HYDROGEN SUCCINATE EQV METHYLPREDNISOLONE(500mg/vial)
	Application Type: GDA-1
	Product Registrant: TRANET HOLDINGS PTE LTD
	Approval Date: 06/05/2026

List of GDAs approved in April 2026

Product Name	Product Information
SITANISH-100 SITAGLIPTIN FILM-COATED TABLET 100MG (SIN17526P)	Active Ingredient(s): Sitagliptin Phosphate Monohydrate eqv Sitagliptin(100mg)
	Application Type: GDA-1
	Product Registrant: ALMA-A PTE LTD
	Approval Date: 28/04/2026
VELSONE FILM COATED TABLETS 800MG (SIN17524P)	Active Ingredient(s): Sevelamer Carbonate(800 mg)
	Application Type: GDA-1
	Product Registrant: SEA PHARMA CONSULTANCY PTE LTD
	Approval Date: 27/04/2026
STRINEORA 100 - CYCLOSPORINE CAPSULES USP 100MG (SIN17521P)	Active Ingredient(s): Cyclosporine(100 mg)
	Application Type: GDA-1
	Product Registrant: STRIDES PHARMA GLOBAL PTE. LIMITED
	Approval Date: 23/04/2026
STRINEORA 50 - CYCLOSPORINE CAPSULES USP 50MG (SIN17522P)	Active Ingredient(s): Cyclosporine(50 mg)
	Application Type: GDA-2
	Product Registrant: STRIDES PHARMA GLOBAL PTE. LIMITED
	Approval Date: 23/04/2026
STRINEORA 25- CYCLOSPORINE CAPSULES USP 25MG (SIN17523P)	Active Ingredient(s): Cyclosporine(25 mg)
	Application Type: GDA-2
	Product Registrant: STRIDES PHARMA GLOBAL PTE. LIMITED
	Approval Date: 23/04/2026
JAMP EPLERENONE TABLETS 25MG (SIN17519P)	Active Ingredient(s): Eplerenone(25mg)
	Application Type: GDA-2
	Product Registrant: GOLDPLUS UNIVERSAL PTE LTD
	Approval Date: 21/04/2026
CLOBAZEN TABLETS 10MG (SIN17520P)	Active Ingredient(s): Clobazam(10 mg)
	Application Type: GDA-1
	Product Registrant: PHARMAZEN MEDICALS PTE LTD
	Approval Date: 21/04/2026
JAMP EPLERENONE TABLETS 50MG (SIN17518P)	Active Ingredient(s): Eplerenone(50mg)
	Application Type: GDA-1
	Product Registrant: GOLDPLUS UNIVERSAL PTE LTD
	Approval Date: 21/04/2026
ALLUTAMIDE SOFT CAPSULES 40MG (SIN17517P)	Active Ingredient(s): Enzalutamide(40 mg)
	Application Type: GDA-1
	Product Registrant: LOTUS INTERNATIONAL PTE. LTD.
	Approval Date: 16/04/2026
NEVOLET 5 NEBIVOLOL TABLETS 5 MG (SIN17514P)	Active Ingredient(s): Nebivolol Hydrochloride equivalent to Nebivolol(5.000 mg)
	Application Type: GDA-1
	Product Registrant: HETERO SINGAPORE PTE. LTD.
	Approval Date: 10/04/2026
ENZALUDEZ SOFT CAPSULE 40MG (SIN17513P)	Active Ingredient(s): Enzalutamide(40.000 mg)
	Application Type: GDA-1
	Product Registrant: SANDOZ SINGAPORE PTE. LTD.
	Approval Date: 08/04/2026
SUGAMMADEX BAXTER SOLUTION FOR INJECTION 100 MG/ML (SIN17512P)	Active Ingredient(s): Sugammadex sodium equivalent to Sugammadex(100 mg/mL)
	Application Type: GDA-1
	Product Registrant: BAXTER HEALTHCARE (ASIA) PTE LTD
	Approval Date: 04/04/2026
AVEXA AVILDAG TABLET 50MG (SIN17509P)	Active Ingredient(s): Vildagliptin(50.000 mg)
	Application Type: GDA-1
	Product Registrant: APEX PHARMA MARKETING PTE. LTD.
	Approval Date: 01/04/2026

List of GDAs approved in March 2026

Product Name	Product Information
ANICURA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG (SIN17508P)	Active Ingredient(s): Anidulafungin(100 mg)
	Application Type: GDA-1
	Product Registrant: INTEGA PTE LTD
	Approval Date: 30/03/2026
XABAREM FILM-COATED TABLETS 10 MG (SIN17506P)	Active Ingredient(s): Rivaroxaban(10 mg)
	Application Type: GDA-2
	Product Registrant: GOLDPLUS UNIVERSAL PTE LTD
	Approval Date: 27/03/2026
XABAREM FILM-COATED TABLETS 20 MG (SIN17504P)	Active Ingredient(s): Rivaroxaban(20 mg)
	Application Type: GDA-1
	Product Registrant: GOLDPLUS UNIVERSAL PTE LTD
	Approval Date: 27/03/2026
XABAREM FILM-COATED TABLETS 2.5 MG (SIN17507P)	Active Ingredient(s): Rivaroxaban(2.5 mg )
	Application Type: GDA-2
	Product Registrant: GOLDPLUS UNIVERSAL PTE LTD
	Approval Date: 27/03/2026
XABAREM FILM-COATED TABLETS 15 MG (SIN17505P)	Active Ingredient(s): Rivaroxaban(15 mg)
	Application Type: GDA-2
	Product Registrant: GOLDPLUS UNIVERSAL PTE LTD
	Approval Date: 27/03/2026
BENDAMUSTINE HYDROCHLORIDE ADVAGEN POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG/VIAL (SIN17503P)	Active Ingredient(s): Bendamustine Hydrochloride Monohydrate equivalent to Bendamustine Hydrochloride(100 mg/vial)
	Application Type: GDA-2
	Product Registrant: ADVAGEN PTE. LTD.
	Approval Date: 26/03/2026
BENDAMUSTINE HYDROCHLORIDE ADVAGEN POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 25 MG/VIAL (SIN17502P)	Active Ingredient(s): Bendamustine Hydrochloride Monohydrate equivalent to Bendamustine Hydrochloride(25 mg/vial)
	Application Type: GDA-1
	Product Registrant: ADVAGEN PTE. LTD.
	Approval Date: 26/03/2026
XYLOCREAM 5% W/W (SIN17501P)	Active Ingredient(s): Lidocaine(2.5 % w/w),Prilocaine(2.5 % w/w)
	Application Type: GDA-1
	Product Registrant: GOLDPLUS UNIVERSAL PTE LTD
	Approval Date: 26/03/2026
ATSWIFT-EZ FILM COATED TABLETS 80MG/10MG (SIN17496P)	Active Ingredient(s): Atorvastatin Calcium Trihydrate equivalent to Atorvastatin(80 mg ),Ezetimibe(10 mg )
	Application Type: GDA-1
	Product Registrant: GOLDPLUS UNIVERSAL PTE LTD
	Approval Date: 25/03/2026
ATSWIFT-EZ FILM COATED TABLETS 40MG/10MG (SIN17497P)	Active Ingredient(s): Atorvastatin Calcium Trihydrate equivalent to Atorvastatin(40 mg ),Ezetimibe(10 mg )
	Application Type: GDA-2
	Product Registrant: GOLDPLUS UNIVERSAL PTE LTD
	Approval Date: 25/03/2026
ATSWIFT-EZ FILM COATED TABLETS 20MG/10MG (SIN17498P)	Active Ingredient(s): Atorvastatin Calcium Trihydrate equivalent to Atorvastatin(20 mg ),Ezetimibe(10 mg )
	Application Type: GDA-2
	Product Registrant: GOLDPLUS UNIVERSAL PTE LTD
	Approval Date: 25/03/2026
ATSWIFT-EZ FILM COATED TABLETS 10MG/10MG (SIN17499P)	Active Ingredient(s): Atorvastatin Calcium Trihydrate equivalent to Atorvastatin(10 mg ),Ezetimibe(10 mg )
	Application Type: GDA-2
	Product Registrant: GOLDPLUS UNIVERSAL PTE LTD
	Approval Date: 25/03/2026
DYDROGESTERONE INTEGA FILM COATED TABLET 10MG (SIN17500P)	Active Ingredient(s): Dydrogesterone(10.00 mg)
	Application Type: GDA-1
	Product Registrant: INTEGA PTE LTD
	Approval Date: 25/03/2026
DURO-TUSS DM DRY COUGH LIQUID 15MG/5ML (SIN17494P)	Active Ingredient(s): Dextromethorphan hydrobromide eqv. Dextromethorphan(15mg/5mL)
	Application Type: GDA-1
	Product Registrant: INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED
	Approval Date: 24/03/2026
MELIFORT EXTENDED RELEASE TABLET 500MG (SIN17492P)	Active Ingredient(s): Metformin Hydrochloride(500mg)
	Application Type: GDA-2
	Product Registrant: APEX PHARMA MARKETING PTE. LTD.
	Approval Date: 23/03/2026
MELIFORT EXTENDED RELEASE TABLET 750MG (SIN17491P)	Active Ingredient(s): Metformin Hydrochloride(750mg)
	Application Type: GDA-2
	Product Registrant: APEX PHARMA MARKETING PTE. LTD.
	Approval Date: 23/03/2026
MELIFORT EXTENDED RELEASE TABLET 1000MG (SIN17490P)	Active Ingredient(s): Metformin Hydrochloride(1000mg)
	Application Type: GDA-1
	Product Registrant: APEX PHARMA MARKETING PTE. LTD.
	Approval Date: 23/03/2026
AMOKLAVIN-BID FILM COATED TABLETS 1000 MG (SIN17489P)	Active Ingredient(s): Amoxicillin Trihydrate eqv Amoxicillin(875 mg ),Potassium Clavulanate eqv Clavulanic Acid(125 mg)
	Application Type: GDA-1
	Product Registrant: GOLDPLUS UNIVERSAL PTE LTD
	Approval Date: 20/03/2026
AIRKEFAY FILM-COATED TABLETS 200MG (SIN17486P)	Active Ingredient(s): Sorafenib Tosylate eqv Sorafenib(200mg)
	Application Type: GDA-1
	Product Registrant: KEXING BIOPHARMA SINGAPORE PTE. LTD.
	Approval Date: 19/03/2026
MEGVAL™ POWDER FOR SOLUTION FOR INJECTION 50MG/VIAL (SIN17483P)	Active Ingredient(s): Melphalan Hydrochloride eqv Melphalan(50 mg/vial)
	Application Type: GDA-1
	Product Registrant: ADVAGEN PTE. LTD.
	Approval Date: 10/03/2026
RESPIRO AEROSOL INHALER 25MCG/250MCG PER DOSE (SIN17479P)	Active Ingredient(s): Fluticasone propionate(250 mcg/dose),Salmeterol xinafoate equivalent to salmeterol(25 mcg/dose)
	Application Type: GDA-1
	Product Registrant: GOLDPLUS UNIVERSAL PTE LTD
	Approval Date: 04/03/2026
RHINOLONE NASAL SPRAY 55 MICROGRAMS/DOSE (SIN17481P)	Active Ingredient(s): Triamcinolone acetonide(55 mcg/dose)
	Application Type: GDA-1
	Product Registrant: NOVEM HEALTHCARE PTE LTD
	Approval Date: 04/03/2026
RESPIRO AEROSOL INHALER 25 MCG/125 MCG PER DOSE (SIN17480P)	Active Ingredient(s): Fluticasone propionate(125 mcg/dose),Salmeterol xinafoate equivalent to salmeterol(25 mcg/dose)
	Application Type: GDA-2
	Product Registrant: GOLDPLUS UNIVERSAL PTE LTD
	Approval Date: 04/03/2026
INSTADIP 25 FILM COATED TABLET USP 25MG (SIN17477P)	Active Ingredient(s): Sitagliptin Phosphate eq to Sitagliptin(25 mg)
	Application Type: GDA-2
	Product Registrant: RANBAXY (MALAYSIA) SDN. BHD.
	Approval Date: 03/03/2026
INSTADIP 100 FILM COATED TABLET USP 100 MG (SIN17478P)	Active Ingredient(s): Sitagliptin Phosphate eq to Sitagliptin(100 mg)
	Application Type: GDA-1
	Product Registrant: RANBAXY (MALAYSIA) SDN. BHD.
	Approval Date: 03/03/2026
INSTADIP 50 FILM COATED TABLET USP 50MG (SIN17476P)	Active Ingredient(s): Sitagliptin Phosphate eq to Sitagliptin(50 mg)
	Application Type: GDA-2
	Product Registrant: RANBAXY (MALAYSIA) SDN. BHD.
	Approval Date: 03/03/2026

List of GDAs approved in February 2026

Product Name	Product Information
OLANZAPINE-TEVA FC TABLET 10MG (SIN17474P)	Active Ingredient(s): Olanzapine(10 mg)
	Application Type: GDA-1
	Product Registrant: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
	Approval Date: 27/02/2026
DREXRED 500 LEVETIRACETAM FILM-COATED TABLETS 500 MG (SIN17475P)	Active Ingredient(s): LEVETIRACETAM(500.00 MG)
	Application Type: GDA-1
	Product Registrant: ZYFAS PHARMA PTE LTD
	Approval Date: 27/02/2026
OLANZAPINE-TEVA FC TABLET 5MG (SIN17473P)	Active Ingredient(s): Olanzapine(5 mg)
	Application Type: GDA-2
	Product Registrant: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
	Approval Date: 27/02/2026
DR. REDDY'S ATORVASTATIN FILM COATED TABLET 40MG USP (SIN17472P)	Active Ingredient(s): Atorvastatin Calcium Trihydrate (Form 1) equivalent to atorvastatin(40mg)
	Application Type: GDA-2
	Product Registrant: ZYFAS PHARMA PTE LTD
	Approval Date: 24/02/2026
TACHYBAN (ADENOSINE INJECTION USP) 3MG/ML (SIN17470P)	Active Ingredient(s): Adenosine(3mg/ml)
	Application Type: GDA-1
	Product Registrant: SIXMURS SINGAPORE PTE. LTD.
	Approval Date: 16/02/2026
DAFASGLIT 10 FILM-COATED TABLETS 10MG (SIN17469P)	Active Ingredient(s): Dapagliflozin(10.000 mg)
	Application Type: GDA-1
	Product Registrant: APOTHECA MARKETING PTE LTD
	Approval Date: 14/02/2026
ROST 20 ROSUVASTATIN TABLETS 20 MG (SIN17466P)	Active Ingredient(s): Rosuvastatin Calcium equivalent to Rosuvastatin(20.000 mg)
	Application Type: GDA-1
	Product Registrant: HETERO SINGAPORE PTE. LTD.
	Approval Date: 11/02/2026
ROST 10 ROSUVASTATIN TABLETS 10 MG (SIN17465P)	Active Ingredient(s): Rosuvastatin Calcium equivalent to Rosuvastatin(10.000 mg)
	Application Type: GDA-2
	Product Registrant: HETERO SINGAPORE PTE. LTD.
	Approval Date: 11/02/2026
ZYROXABAN FILM COATED TABLET 10MG (SIN17463P)	Active Ingredient(s): RIVAROXABAN (MICRONISED)(10MG)
	Application Type: GDA-2
	Product Registrant: APEX PHARMA MARKETING PTE. LTD.
	Approval Date: 10/02/2026
ZYROXABAN FILM COATED TABLET 20MG (SIN17461P)	Active Ingredient(s): Rivaroxaban (micronised)(20mg)
	Application Type: GDA-1
	Product Registrant: APEX PHARMA MARKETING PTE. LTD.
	Approval Date: 10/02/2026
OBITOCIN SOLUTION FOR INJECTION IN PREFILLED SYRINGE 100MCG/ML (SIN17464P)	Active Ingredient(s): Carbetocin(100 mcg/ml)
	Application Type: GDA-1
	Product Registrant: UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
	Approval Date: 10/02/2026
ZYROXABAN FILM COATED TABLET 15MG (SIN17462P)	Active Ingredient(s): Rivaroxaban (micronised)(15mg)
	Application Type: GDA-2
	Product Registrant: APEX PHARMA MARKETING PTE. LTD.
	Approval Date: 10/02/2026
TORVASTATIN FC TABLET 40MG (SIN17457P)	Active Ingredient(s): Atorvastatin Calcium eqv to Atorvastatin(40mg)
	Application Type: GDA-2
	Product Registrant: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
	Approval Date: 09/02/2026
TORVASTATIN FC TABLET 10MG (SIN17459P)	Active Ingredient(s): Atorvastatin Calcium eqv to Atorvastatin(10mg)
	Application Type: GDA-2
	Product Registrant: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
	Approval Date: 09/02/2026
TORVASTATIN FC TABLET 80MG (SIN17456P)	Active Ingredient(s): Atorvastatin Calcium eqv to Atorvastatin(80mg)
	Application Type: GDA-1
	Product Registrant: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
	Approval Date: 09/02/2026
TORVASTATIN FC TABLET 20MG (SIN17458P)	Active Ingredient(s): Atorvastatin Calcium eqv to Atorvastatin(20mg)
	Application Type: GDA-2
	Product Registrant: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
	Approval Date: 09/02/2026
ESOMEPRAZOLE AUXILTO GASTRO-RESISTANT TABLETS 40MG (SIN17454P)	Active Ingredient(s): Esomeprazole Magnesium Trihydrate eqv. Esomeprazole(40mg)
	Application Type: GDA-1
	Product Registrant: AUXILTO IMPEX PTE. LTD.
	Approval Date: 09/02/2026
ESOMEPRAZOLE AUXILTO GASTRO-RESISTANT TABLETS 20MG (SIN17455P)	Active Ingredient(s): Esomeprazole Magnesium Trihydrate eqv. Esomeprazole(20mg)
	Application Type: GDA-2
	Product Registrant: AUXILTO IMPEX PTE. LTD.
	Approval Date: 09/02/2026
NOREPINEPHRINE SCIGEN CONCENTRATE FOR SOLUTION FOR INFUSION 4 MG/4ML (SIN17453P)	Active Ingredient(s): Norepinephrine Bitartrate eqv. Norephinephrine(4mg/4ml)
	Application Type: GDA-1
	Product Registrant: SCIGEN PTE. LTD.
	Approval Date: 04/02/2026
TRANEXAMIC ACID MEVON FILM-COATED TABLETS 500 MG (SIN17452P)	Active Ingredient(s): Tranexamic acid(500.00 mg)
	Application Type: GDA-1
	Product Registrant: NOVEM HEALTHCARE PTE LTD
	Approval Date: 03/02/2026
RIVAROXABAN-TEVA FC TABLET 10MG (SIN17450P)	Active Ingredient(s): Rivaroxaban(10 mg)
	Application Type: GDA-2
	Product Registrant: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
	Approval Date: 02/02/2026
RIVAROXABAN-TEVA FC TABLET 15MG (SIN17449P)	Active Ingredient(s): Rivaroxaban(15 mg)
	Application Type: GDA-2
	Product Registrant: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
	Approval Date: 02/02/2026
RIVAROXABAN-TEVA FC TABLET 20MG (SIN17448P)	Active Ingredient(s): Rivaroxaban(20 mg)
	Application Type: GDA-1
	Product Registrant: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
	Approval Date: 02/02/2026
RIVAROXABAN-TEVA FC TABLET 2.5MG (SIN17451P)	Active Ingredient(s): Rivaroxaban(2.5 mg)
	Application Type: GDA-2
	Product Registrant: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
	Approval Date: 02/02/2026

List of GDAs approved in January 2026

Product Name	Product Information
PHENASEN CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/10ML (SIN17447P)	Active Ingredient(s): Arsenic Trioxide(10mg/10ml)
	Application Type: GDA-1
	Product Registrant: PHEBRA (SE ASIA) PTE. LTD.
	Approval Date: 29/01/2026
MOXICLAV POWDER FOR SOLUTION FOR INJECTION/ INFUSION 1.2G/VIAL (SIN17446P)	Active Ingredient(s): Amoxicillin sodium eqv. to Amoxicillin(1000mg/vial),Potassium clavulanate eqv. to Clavulanic acid(200mg/vial)
	Application Type: GDA-1
	Product Registrant: MEDOCHEMIE SINGAPORE PTE. LTD.
	Approval Date: 27/01/2026
JAMP-CHOLESTYRAMINE POWDER FOR ORAL SUSPENSION 4G (SIN17445P)	Active Ingredient(s): Cholestyramine resin(4000mg)
	Application Type: GDA-1
	Product Registrant: GOLDPLUS UNIVERSAL PTE LTD
	Approval Date: 23/01/2026
ZYGABALIN HARD CAPSULE 50MG (SIN17444P)	Active Ingredient(s): Pregabalin(50mg)
	Application Type: GDA-2
	Product Registrant: APEX PHARMA MARKETING PTE. LTD.
	Approval Date: 22/01/2026
ZYGABALIN HARD CAPSULE 150MG (SIN17442P)	Active Ingredient(s): Pregabalin(150mg)
	Application Type: GDA-1
	Product Registrant: APEX PHARMA MARKETING PTE. LTD.
	Approval Date: 22/01/2026
ZYGABALIN HARD CAPSULE 75MG (SIN17443P)	Active Ingredient(s): Pregabalin(75mg)
	Application Type: GDA-2
	Product Registrant: APEX PHARMA MARKETING PTE. LTD.
	Approval Date: 22/01/2026
GP-KETOPROFEN PLASTER 30MG/PLASTER (SIN17441P)	Active Ingredient(s): Ketoprofen(30 mg/plaster)
	Application Type: GDA-1
	Product Registrant: GOLDPLUS UNIVERSAL PTE LTD
	Approval Date: 16/01/2026
EBUNAT SOLUTION FOR INJECTION 0.5MG/ML (SIN17432P)	Active Ingredient(s): ERIBULIN MESYLATE(0.5 mg/ml)
	Application Type: GDA-1
	Product Registrant: NATCO PHARMA ASIA PTE. LTD.
	Approval Date: 13/01/2026
MICAFUNGIN-AFT POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 50MG/VIAL (SIN17429P)	Active Ingredient(s): MICAFUNGIN SODIUM EQUIVALENT TO MICAFUNGIN(50MG/vial)
	Application Type: GDA-1
	Product Registrant: APEX PHARMA MARKETING PTE. LTD.
	Approval Date: 09/01/2026
APIGAT 5 FILM COATED TABLETS 5 MG (SIN17430P)	Active Ingredient(s): Apixaban(5.00mg)
	Application Type: GDA-1
	Product Registrant: NATCO PHARMA ASIA PTE. LTD.
	Approval Date: 09/01/2026
APIGAT 2.5 FILM COATED TABLETS 2.5MG (SIN17431P)	Active Ingredient(s): Apixaban(2.5mg)
	Application Type: GDA-2
	Product Registrant: NATCO PHARMA ASIA PTE. LTD.
	Approval Date: 09/01/2026
DAPIGA FILM COATED TABLETS 10MG (SIN17427P)	Active Ingredient(s): Dapagliflozin(10 mg)
	Application Type: GDA-1
	Product Registrant: SEA PHARMA CONSULTANCY PTE LTD
	Approval Date: 06/01/2026

List of GDAs approved in 2025 [PDF, 124.50 KB] (opens in new tab)

List of GDAs approved in 2024 [PDF, 95.95 KB] (opens in new tab)

Major Variation Applications (MAV)

MAVs approved in July 2026

Product Name	Product Information
DATROWAY POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL (SIN17234P)	Active Ingredient(s): Datopotamab deruxtecan(100 mg/vial)
	Product Registrant: ASTRAZENECA SINGAPORE PTE LTD
	Approval Date: 29/07/2026
	Indication: DATROWAY is indicated for the treatment of adult patients with unresectable or metastatic
WINREVAIR® POWDER FOR SOLUTION FOR INJECTION 45MG (SIN17091P) WINREVAIR® POWDER FOR SOLUTION FOR INJECTION 45MG (VIAL ONLY)(SIN17093P) WINREVAIR® POWDER FOR SOLUTION FOR INJECTION 60MG (SIN17092P) WINREVAIR® POWDER FOR SOLUTION FOR INJECTION 60MG (VIAL ONLY)(SIN17094P)	Active Ingredient(s): (Powder vial) sotatercept(45mg)
	Product Registrant: MSD PHARMA (SINGAPORE) PTE. LTD.
	Approval Date: 21/07/2026
	Indication: WINREVAIR is indicated for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 pulmonary hypertension) with World Health Organization (WHO) Functional Class [FC] II to IV[see clinical studies]
ENHERTU POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL (SIN16352P)	Active Ingredient(s): Trastuzumab deruxtecan(100 mg/vial)
	Product Registrant: ASTRAZENECA SINGAPORE PTE LTD
	Approval Date: 06/07/2026
	Indication: ENHERTU followed by a taxane, trastuzumab, and pertuzumab (THP) is indicated for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer.

MAVs approved in June 2026

Product Name	Product Information
DATROWAY POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL (SIN17234P)	Active Ingredient(s): Datopotamab deruxtecan(100 mg/vial)
	Product Registrant: ASTRAZENECA SINGAPORE PTE LTD
	Approval Date: 30/06/2026
	Indication: DATROWAY is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
ENHERTU POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL (SIN16352P)	Active Ingredient(s): Trastuzumab deruxtecan(100 mg/vial)
	Product Registrant: ASTRAZENECA SINGAPORE PTE LTD
	Approval Date: 29/06/2026
	Indication: ENHERTU is indicated for the treatment of adult patients with locally advanced or metastaticHER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
ENHERTU POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL (SIN16352P)	Active Ingredient(s): Trastuzumab deruxtecan(100 mg/vial)
	Product Registrant: ASTRAZENECA SINGAPORE PTE LTD
	Approval Date: 23/06/2026
	Indication: Metastatic Breast Cancer HER2-Positive ENHERTU in combination with pertuzumab is indicated for the first-line treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer.
WEGOVY 0.25 MG, 0.5 MG, 1 MG, 1.7 MG, 2.4 MG /DOSE FLEXTOUCH SOLUTION FOR INJECTION IN PRE-FILLED PEN 0.68 MG/ML (SIN16744P, SIN16745P, SIN16746P, SIN16747P, SIN16748P) WEGOVY SOLUTION FOR INJECTION IN PRE-FILLED PEN 0.25MG, 0.5MG/0.5ML, 1.7MG/0.75ML, 1MG/0.5ML, 2.4MG/0.75ML, (SIN16706P, SIN16705P, SIN16707P, SIN16704P, SIN16708P)	Active Ingredient(s): Semaglutide(0.68mg/mL)
	Product Registrant: NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
	Approval Date: 23/06/2026
	Indication: Adults Wegovy® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of • ≥30 kg/m2 (obesity), or • ≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weightrelated comorbidity e.g. dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease. • to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight (see section 5.1). Adolescents (≥12 years) Wegovy® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with • obesity* and • body weight above 60 kg.

MAVs approved in May 2026

Product Name	Product Information
ICLUSIG TABLET 15 MG (SIN15581P) and 45MG(SIN15582P)	Active Ingredient(s): PONATINIB HCl EQV PONATINIB(15 MG)
	Product Registrant: STEWARD CROSS PTE LTD
	Approval Date: 26/05/2026
	Indication: Inclusig is indicated in adult patients with newly diagnosed Ph+ ALL in combination with reduced intensity chemotherapy.
TREMFYA PUSHPEN SOLUTION FOR INJECTION IN PRE-FILLED PEN 200MG/2ML (SIN17286P) AND PRE-FILLED SYRINGE 200MG/2ML (SIN17287P)	Active Ingredient(s): Guselkumab(200 mg/2mL)
	Product Registrant: JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
	Approval Date: 25/05/2026
	Indication: TREMFYA® is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.

MAVs approved in Jan - Apr 2026

Product Name	Product Information
JAKAVI TABLET 10MG (SIN14927P), JAKAVI TABLET 15MG (SIN14397P), JAKAVI TABLET 20MG (SIN14398P), JAKAVI TABLET 5MG (SIN14396P)	Active Ingredient(s): Ruxolitinib Phosphate 13.20mg eqv Ruxolinitib(10mg), Ruxolitinib Phosphate 19.80mg eqv Ruxolitinib(15mg), Ruxolitinib Phosphate 26.40mg eqv Ruxolitinib(20mg), Ruxolitinib Phosphate 6.60mg eqv Ruxolitinib(5mg)
	Product Registrant: NOVARTIS (SINGAPORE) PTE LTD
	Approval Date: 02/04/2026
	Indication: Acute Graft-versus-host disease Jakavi is indicated for the treatment of patients with acute Graft versus Host Disease (aGvHD) aged 6 years and older who have inadequate response to corticosteroids. Chronic Graft-versus-host disease Jakavi is indicated for the treatment of patients with chronic Graft versus Host Disease (cGvHD) aged 6 years and older who have inadequate response to corticosteroids.
SPRAVATO NASAL SPRAY 28MG/VIAL (SIN16033P)	Active Ingredient(s): Esketamine HCl 32.2mg eqv. to Esketamine(28mg/vial)
	Product Registrant: JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
	Approval Date: 08/04/2026
	Indication: SPRAVATO®, as monotherapy or in combination with an oral antidepressant (SSRI or SNRI), is indicated for treatment-resistant depression (Major Depressive Disorder in adults who have not responded adequately to at least two different antidepressants of adequate dose and duration to treat the current depressive episode).
IMFINZI CONCENTRATE FOR SOLUTION FOR INFUSION 50 MG/ML (SIN15569P)	Active Ingredient(s): Durvalumab(50 mg/ml)
	Product Registrant: ASTRAZENECA SINGAPORE PTE LTD
	Approval Date: 08/04/2026
	Indication: IMFINZI in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant IMFINZI monotherapy, is indicated for the treatment of patients with resectable gastric or gastroesophageal junction adenocarcinoma.
LUTATHERA SOLUTION FOR INFUSION 370 MBQ/ML (SIN15947P)	Active Ingredient(s): Lutetium (177Lu) oxodotreotide(370 Mbq/ml)
	Product Registrant: NOVARTIS (SINGAPORE) PTE LTD
	Approval Date: 09/04/2026
	Indication: Lutathera® is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in patients aged 12 years and older.
OMNIPAQUE INJECTION 300 MG I/ML (SIN05924P), OMNIPAQUE INJECTION 350 MG I/ML (SIN05923P)	Active Ingredient(s): IOHEXOL 647 mg/ml EQV IODINE(300 mg/ml), IOHEXOL 755 mg/ml EQV IODINE(350 mg/ml)
	Product Registrant: GE HEALTHCARE PTE. LTD.
	Approval Date: 15/04/2026
	Indication: Contrast enhanced mammography (CEM) in adults to evaluate and detect known or suspected lesions of the breast, as an adjunct to mammography (with or without ultrasound) or as an alternative to magnetic resonance imaging (MRI) when MRI is contraindicated or unavailable.
ADCETRIS® POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 50MG/VIAL (SIN14477P)	Active Ingredient(s): BRENTUXIMAB VEDOTIN(50mg/vial)
	Product Registrant: TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
	Approval Date: 15/04/2026
	Indication: Previously untreated Stage IIb with risk factor, Stage III or Stage IV classical Hodgkin Lymphoma (cHL), in combination with chemotherapy. ADCETRIS is indicated for adult patients with previously untreated CD30+ Stage IIB with risk factors, Stage III or Stage IV cHL in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone (BrECADD) (see sections 4.2 and 5.1).
NUBEQA FILM-COATED TABLET 300MG (SIN16103P)	Active Ingredient(s): Darolutamide milled(300mg)
	Product Registrant: BAYER (SOUTH EAST ASIA) PTE LTD
	Approval Date: 22/04/2026
	Indication: NUBEQA is indicated for the treatment of adult men with - metastatic hormone-sensitive prostate cancer (mHSPC) (see section 5.1).
LOQTORZI CONCENTRATE FOR SOLUTION FOR INFUSION 240MG/6ML (SIN17212P)	Active Ingredient(s): Toripalimab(240mg/6mL)
	Product Registrant: TA BIOSCIENCES PTE. LTD.
	Approval Date: 23/04/2026
	Indication: LOQTORZI, in combination with cisplatin and paclitaxel, is indicated for the first-line treatment of adult patients with metastatic or recurrent oesophageal squamous cell carcinoma (OSCC) not amenable to surgery or radiotherapy.
ACAM2000 (SIN13748P)	Active Ingredient(s): LIVE VACCINA VIRUS(1.0 x10⁸ - 5.0 x10⁸ PFU/ml)
	Product Registrant: EMERGENT SALES AND MARKETING SINGAPORE PTE. LTD.
	Approval Date: 27/04/2026
	Indication: ACAM2000 is a vaccine indicated for active immunization for the prevention of mpox disease in adults determined to be at high risk for mpox infection, for use during mpox outbreaks associated with severe or life-threatening disease where alternative vaccines are unavailable or contraindicated. ACAM2000 should be used in accordance with official recommendations.
LUMAKRAS FILM-COATED TABLET 120MG (SIN16522P)	Active Ingredient(s): Sotorasib(120mg)
	Product Registrant: AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD
	Approval Date: 28/04/2026
	Indication: LUMAKRAS, in combination with panitumumab, is indicated for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
KERENDIA FILM-COATED TABLET 10MG, 20MG	Active Ingredient(s): Finerenone(10mg, 20mg)
	Product Registrant: BAYER (SOUTH EAST ASIA) PTE LTD
	Approval date: 30/03/2026
	Product Registration Number: SIN16387P, SIN16388P
	Indication: Heart Failure (LVEF ≥40%) Kerendia is indicated for the treatment of symptomatic chronic heart failure and left ventricular ejection fraction (LVEF) ≥40% in adults (See section 5.1.3 Clinical efficacy and safety).
TECENTRIQ CONCENTRATE FOR SOLUTION FOR INFUSION 1200 MG/ 20 ML, 840MG/14ML; TECENTRIQ SOLUTION FOR INJECTION 1875MG/15ML	Active Ingredient(s): Atezolizumab(1200 mg, 840mg/14ml, 1875 mg/15ml)
	Product Registrant: ROCHE SINGAPORE PTE. LTD.
	Approval date: 30/03/2026
	Product Registration Number: SIN15425P, SIN15964P, SIN17033P
	Indication: Tecentriq, in combination with lurbinectedin, is indicated for the maintenance treatment of adult patients with ES-SCLC whose disease has not progressed after first-line induction therapy with Tecentriq, carboplatin and etoposide
ZEPZELCA POWDER FOR SOLUTION FOR INFUSION 4MG/VIAL	Active Ingredient(s): Lurbinectedin(4.0 mg/vial)
	Product Registrant: SPECIALISED THERAPEUTICS ASIA PTE LTD
	Approval date: 30/03/2026
	Product Registration Number: SIN16327P
	Indication: ZEPZELCA, in combination with atezolizumab, is indicated for the maintenance treatment of extensive-stage small cell lung cancer (SCLC) in adult patients whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.
BRAFTOVI HARD CAPSULE 50MG, 75MG	Active Ingredient(s): Encorafenib(50mg)
	Product Registrant: PIERRE FABRE SINGAPORE PTE. LTD.
	Approval date: 26/03/2026
	Product Registration Number: SIN16825P, SIN16824P
	Indication: Non-small cell lung cancer (NSCLC) Encorafenib, in combination with binimetinib, is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.
MEKTOVI FILM-COATED TABLET 15MG	Active Ingredient(s):Binimetinib(15mg)
	Product Registrant:PIERRE FABRE SINGAPORE PTE. LTD.
	Approval date:26/03/2026
	Product Registration Number:SIN16826P
	Indication:Non-small cell lung cancer (NSCLC) Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.
TEVIMBRA CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/10ML	Active Ingredient(s):Tislelizumab(100mg/10mL )
	Product Registrant:BEONE MEDICINES SINGAPORE PTE. LTD.
	Approval date:19/03/2026
	Product Registration Number:SIN17089P
	Indication: Tevimbra in combination with platinum-based chemotherapy as neoadjuvant treatment and then continued as Tevimbra monotherapy as adjuvant treatment following surgery is indicated for the treatment of patients with resectable NSCLC at high risk of recurrence and who have no known EGFR mutations or ALK rearrangements. Tevimbra in combination with etoposide and platinum-containing chemotherapy is indicated for the first-line treatment of patients with extensive-stage SCLC.
RINVOQ EXTENDED-RELEASE TABLET 15MG, 30MG, 45MG	Active ingredient(s): Upadacitinib Hemihydrate eqv Upadacitinib(15mg, 30mg, 45mg)
	Product registrant: ABBVIE PTE. LTD.
	Approval date: 18/03/2026
	Product Registration Number: SIN15959P, SIN16518P, SIN16687P
	Indication: RINVOQ is indicated for the treatment of adults with giant cell arteritis
GENOTROPIN FOR INJECTION 16 IU (5.3 MG) /ML	Active ingredient(s):Somatropin Recombinant(5.3 mg/ml)
	Product Registrant:PFIZER PRIVATE LIMITED
	Approval date:27/02/2026
	Product Registration Number: SIN16968P
	Indication: Improvement of growth and body composition in children with Prader Willi syndrome (PWS).
COLUMVI CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/ML	Active ingredient(s):Glofitamab(1 mg/ml)
	Product Registrant:ROCHE SINGAPORE PTE. LTD.
	Approval date:24/02/2026
	Product Registration Number:SIN16968P
	Indication:Columvi in combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are not candidates for autologous stem cell transplant (ASCT).
DARZALEX SC SOLUTION FOR INJECTION 1800MG/15ML	Active ingredient(s):Daratumumab(1800mg/15mL)
	Product Registrant:JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
	Approval date:20/02/2026
	Product Registration Number:SIN16032P
	Indication:DARZALEX® SC is indicated for the treatment of patients with multiple myeloma: - in combination with bortezomib, lenalidomide and dexamethasone in newly diagnosed patients
MENQUADFI SOLUTION FOR INJECTION	Active ingredient(s): Meningococcal Polysaccharide, Serogroup A (Monovalent Conjugate)(10 mcg/ 0.5 mL),Meningococcal Polysaccharide, Serogroup C (Monovalent Conjugate)(10 mcg/ 0.5 mL),Meningococcal Polysaccharide, Serogroup W-135 (Monovalent Conjugate)(10 mcg / 0.5mL),Meningococcal Polysaccharide, Serogroup Y (Monovalent Conjugate)(10 mcg/ 0.5 mL),Tetanus Toxoid, Filtered Concentrate (Carrier Protein)(55 mcg/ 0.5 mL)
	Product Registrant:SANOFI-AVENTIS SINGAPORE PTE. LTD.
	Approval date:13/02/2026
	Product Registration Number:SIN16454P
	Indication:MenQuadfi is indicated for active immunisation of individuals from the age of 6 weeks and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. The use of this vaccine should be in accordance with available official recommendations.
KISQALI FILM-COATED TABLET 200MG	Active ingredient(s):Ribociclib Succinate 254.4mg eqv Ribociclib(200mg)
	Product Registrant:NOVARTIS (SINGAPORE) PTE LTD
	Approval date:05/02/2026
	Product Registration Number:SIN15407P
	Indication:Early breast cancer Kisqali in combination with an aromatase inhibitor is indicated for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence (see section Clinical studies).
GAMUNEX®-C SOLUTION FOR INFUSION 10%	Active ingredient(s):Human Normal Immunoglobulin(0.1g /mL)
	Product Registrant:GRIFOLS ASIA PACIFIC PTE. LTD.
	Approval date:29/01/2026
	Product Registration Number:SIN14928P
	Replacement therapy in adults, children and adolescents (0-18 years) in: • Primary immunodeficiency syndromes (PID) with impaired antibody production • Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l *PSAF = failure to mount at least a 2-fold rise in IgG antibody titer to pneumococcal polysaccharide and polypeptide antigen vaccines Measles pre-/post exposure prophylaxis for susceptible adults, children and adolescents (0-18 years) in whom active immunization is contraindicated or not advised. Consideration should also be given to official recommendations on intravenous human Immunomodulation in adults aged ≥18 years in: • Severe acute exacerbations of myasthenia gravis Immunomodulation in adults aged ≥18 years in: • Severe acute exacerbations of myasthenia gravis immunoglobulin use in measles pre-/post exposure prophylaxis and active immunization. Immunomodulation in adults, children and adolescents (0-18 years) in: • Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count • Guillain Barré syndrome • Kawasaki disease (in conjunction with acetylsalicylic acid; see 4.2) • Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) • Multifocal motor neuropathy (MMN)
ZAVICEFTA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 2G/0.5G	Active ingredient(s):Avibactam sodium 543.5 mg eqv. to Avibactam(500mg),Ceftazidime pentahydrate 2329.7 mg eqv. to Ceftazidime(2g)
	Product Registrant:PFIZER PRIVATE LIMITED
	Approval date:15/01/2026
	Product Registration Number:SIN15870P
	Indication:Zavicefta is indicated in adults and paediatric patients from birth for the treatment of the following infections (see sections 4.4 and 5.1): - Complicated Intra-Abdominal Infection (cIAI) - Complicated Urinary Tract Infection (cUTI), including pyelonephritis - Hospital-acquired Pneumonia (HAP), including ventilator associated pneumonia (VAP)

Click here to view older listings of drug indication approvals.

Reclassification

View the list of reclassified therapeutic products (MAV-2).