Molecules / India

API manufacturers in India

396 molecules 296 manufacturers Updated 9 July 2026

296 manufacturers based in India hold an active filing across 396 molecules in this directory, and 226 of them hold a US DMF or a valid CEP.

296
manufacturers with an active filing226 hold a US DMF or a CEP
396
molecules made here225 where India holds over half the makers we list
47%
have a published FDA inspection 7 carry an OAI

Molecules made in India

Molecule In India Worldwide Holding a DMF or CEP
Dapagliflozin 19 45 19
Levetiracetam 18 41 18
Losartan 18 35 18
Lurasidone 18 29 18
Pirfenidone 18 27 18
Pregabalin 18 58 18
Rivaroxaban 18 81 18
Donepezil 17 27 17
Empagliflozin 17 49 17
Lacosamide 17 29 16
Mirabegron 17 34 17
Olmesartan 17 28 17
Sertraline 17 24 17
Apixaban 16 55 16
Atorvastatin 16 58 16
Bosentan 16 25 14
Deferasirox 16 24 15
Ezetimibe 16 34 16
Lamotrigine 16 26 16
Olanzapine 16 31 15
Sitagliptin 16 67 16
Valsartan 16 46 16
Amlodipine 15 43 15
Carvedilol 15 24 15
Celecoxib 15 56 15
Cinacalcet 15 22 15
Clopidogrel 15 46 15
Dabigatran Etexilate 15 28 15
Dimethyl 15 24 13
Duloxetine 15 32 15
Edoxaban 15 22 15
Escitalopram 15 29 14
Lamivudine 15 23 15
Lansoprazole 15 29 15
Linagliptin 15 36 15
Pantoprazole 15 60 15
Rosuvastatin 15 59 15
Sildenafil 15 29 14
Solifenacin 15 36 14
Telmisartan 15 48 15
Venlafaxine 15 35 15
Apremilast 14 27 14
Bempedoic Acid 14 16 13
Bupropion 14 26 14
Desvenlafaxine 14 16 14
Dolutegravir 14 19 14
Enzalutamide 14 27 14
Esomeprazole 14 61 14
Famotidine 14 30 13
Linezolid 14 32 14
Omeprazole 14 44 14
Oxcarbazepine 14 21 13
Paliperidone 14 23 14
Quetiapine 14 47 14
Ranolazine 14 19 14
Tenofovir Disoproxil 14 46 14
Teriflunomide 14 23 14
Ticagrelor 14 54 14
Varenicline 14 19 14
Citalopram 13 18 12
Darunavir 13 14 13
Fluconazole 13 21 11
Glycopyrronium 13 23 6
Lenalidomide 13 25 12
Memantine 13 28 12
Mesalamine 13 30 8
Mesalazine 13 30 8
Montelukast 13 34 13
Moxifloxacin 13 40 12
Olmesartan Medoxomil 13 25 13
Rabeprazole 13 24 13
Rizatriptan 13 17 13
Sacubitril 13 27 12
Tadalafil 13 39 12
Tafamidis 13 17 13
Vonoprazan 13 29 13
Voriconazole 13 29 13
Vortioxetine 13 20 13
Aripiprazole 12 44 12
Atomoxetine 12 16 10
Brexpiprazole 12 20 12
Brivaracetam 12 22 12
Capecitabine 12 19 11
Cetirizine 12 33 12
Desloratadine 12 26 11
Dexlansoprazole 12 16 12
Febuxostat 12 29 12
Fexofenadine 12 36 11
Irbesartan 12 45 12
Metformin 12 38 12
Metoprolol 12 26 12
Ondansetron 12 24 10
Oseltamivir 12 23 12
Rifaximin 12 19 12
Risperidone 12 25 11
Sugammadex 12 35 12
Tenofovir Alafenamide 12 24 12
Tramadol 12 25 12
Valaciclovir 12 17 10
Valacyclovir 12 17 10
Valganciclovir 12 18 9
Vildagliptin 12 34 10
Zolmitriptan 12 14 11
Atazanavir 11 15 11
Bisoprolol 11 28 11
Bortezomib 11 19 11
Canagliflozin 11 21 11
Chlorthalidone 11 13 11
Dasatinib 11 22 11
Dextromethorphan 11 21 11
Dronedarone 11 14 11
Eltrombopag 11 22 11
Entacapone 11 14 9
Eslicarbazepine 11 17 11
Gabapentin 11 34 11
Imatinib 11 20 11
Meloxicam 11 28 10
Palbociclib 11 23 11
Pioglitazone 11 14 11
Pramipexole 11 23 11
Rivastigmine 11 17 11
Tamsulosin 11 26 10
Topiramate 11 16 11
Trazodone 11 16 11
Viloxazine 11 14 11
Ziprasidone 11 14 11
Zolpidem 11 16 11
Allopurinol 10 21 10
Erlotinib 10 16 9
Eszopiclone 10 13 9
Fenofibrate 10 25 10
Hydralazine 10 14 10
Hydrochlorothiazide 10 16 10
Imatinib Mesilate 10 14 9
Itraconazole 10 18 10
Ivacaftor 10 12 10
Levocetirizine 10 21 9
Milnacipran 10 13 10
Prasugrel 10 11 10
Raloxifene 10 15 9
Ramipril 10 20 9
Ritonavir 10 16 10
Ruxolitinib 10 14 10
Saxagliptin 10 18 9
Sumatriptan 10 16 10
Terbinafine 10 27 10
Abacavir 9 16 9
Albendazole 9 15 9
Azilsartan Medoxomil 9 19 9
Bilastine 9 16 8
Cariprazine 9 13 9
Cefixime 9 26 7
Dabigatran Etexilate Mesilate 9 12 9
Darifenacin 9 10 9
Efavirenz 9 12 9
Efinaconazole 9 16 9
Elagolix 9 19 9
Emtricitabine 9 16 9
Erythromycin 9 22 9
Ferric Carboxymaltose 9 18 7
Finerenone 9 18 9
Fingolimod 9 17 9
Fosaprepitant 9 17 9
Gemcitabine 9 16 8
Letrozole 9 14 7
Levofloxacin 9 48 9
Lidocaine 9 20 5
Loratadine 9 23 8
Mirtazapine 9 17 8
Olaparib 9 19 9
Pemetrexed 9 22 9
Pomalidomide 9 17 8
Prucalopride 9 13 8
Repaglinide 9 14 8
Sorafenib 9 14 9
Tofacitinib 9 28 9
Torasemide 9 19 6
Vardenafil 9 14 6
Vilazodone 9 11 9
Abiraterone 8 22 8
Acyclovir 8 39 7
Albuterol 8 24 7
Alendronic Acid 8 11 7
Aprepitant 8 16 8
Atovaquone 8 10 8
Azithromycin 8 25 8
Betahistine 8 20 4
Buspirone 8 11 8
Cefuroxime 8 29 8
Colchicine 8 19 8
Dorzolamide 8 12 7
Fesoterodine 8 11 8
Fluphenazine 8 10 8
Glimepiride 8 26 8
Hydroxychloroquine 8 18 8
Hydroxyzine 8 10 8
Ibrutinib 8 16 8
Icatibant 8 14 8
Labetalol 8 15 7
Macitentan 8 15 8

Showing the 200 molecules with the most India-based makers, of 396. Every molecule page lists its India suppliers.

How these figures are counted

Counts are of distinct companies, not filings, and cover the manufacturers in this directory rather than all production in India. Shares are stated on that basis. How we count our figures.

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
GMP certificates
EMA, US FDA, CDSCO (India), MFDS (Korea), MHRA (UK), NAFDAC (NG)

Questions

How many API manufacturers are based in India?
296 distinct manufacturers based in India hold an active regulatory filing for at least one of the 396 molecules covered here, and 226 hold a US drug master file or a valid CEP. Counts come from the FDA drug master file list, the EDQM certificate database and national registers, as at 9 July 2026.
Which regulators recognise India sites?
GMP certificates held by these suppliers come from EMA, US FDA, CDSCO (India), MFDS (Korea), MHRA (UK), NAFDAC (NG). GMP recognition covers the manufacturing site, separately from any filing on the substance itself.
How do India suppliers perform on FDA inspections?
139 of the 296 suppliers here (47%) have a published FDA inspection classification, and 7 carry an OAI, the worst outcome. Suppliers never inspected do not appear in that count, so this describes the inspected population rather than all of India.
Which molecules is India strongest on?
India holds more than half the manufacturers we list for 225 of 396 molecules. The table is ordered by how many India-based makers each molecule has. Shares are of the manufacturers in this directory, not of world production.

Source from India?

Tell us the molecules and the markets you file in. These suppliers come back tiered for those markets, with the price corridor and an RFI sheet.

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Other countries

China 118 United States 11 Italy 2

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