Molecules / India

API manufacturers in India

406 molecules 301 manufacturers Updated 9 July 2026

301 manufacturers based in India hold an active filing across 406 molecules in this directory, and 229 of them hold a US DMF or a valid CEP.

301
manufacturers with an active filing229 hold a US DMF or a CEP
406
molecules made here239 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 19 41 18
Losartan 19 35 18
Pregabalin 19 58 18
Empagliflozin 18 49 17
Lacosamide 18 29 16
Lurasidone 18 29 18
Pirfenidone 18 27 18
Rivaroxaban 18 81 18
Atorvastatin 17 58 16
Donepezil 17 27 17
Mirabegron 17 34 17
Olmesartan 17 28 17
Sertraline 17 24 17
Sitagliptin 17 67 16
Valsartan 17 46 16
Apixaban 16 55 16
Bosentan 16 25 14
Celecoxib 16 56 15
Cinacalcet 16 22 15
Dabigatran Etexilate 16 28 15
Deferasirox 16 24 15
Edoxaban 16 22 15
Escitalopram 16 29 14
Ezetimibe 16 34 16
Lamivudine 16 23 15
Lamotrigine 16 26 16
Lansoprazole 16 29 15
Linagliptin 16 36 15
Olanzapine 16 31 15
Sildenafil 16 29 14
Venlafaxine 16 35 15
Amlodipine 15 43 15
Apremilast 15 27 14
Bempedoic Acid 15 16 13
Carvedilol 15 24 15
Clopidogrel 15 46 15
Desvenlafaxine 15 16 14
Dimethyl 15 24 13
Dolutegravir 15 19 14
Duloxetine 15 32 15
Famotidine 15 30 13
Pantoprazole 15 60 15
Ranolazine 15 19 14
Rosuvastatin 15 59 15
Solifenacin 15 36 14
Telmisartan 15 48 15
Tenofovir Disoproxil 15 46 14
Ticagrelor 15 54 14
Bupropion 14 26 14
Darunavir 14 14 13
Enzalutamide 14 27 14
Esomeprazole 14 61 14
Linezolid 14 32 14
Memantine 14 28 12
Mesalamine 14 30 8
Mesalazine 14 30 8
Montelukast 14 34 13
Moxifloxacin 14 40 12
Omeprazole 14 44 14
Oxcarbazepine 14 21 13
Paliperidone 14 23 14
Quetiapine 14 47 14
Rabeprazole 14 24 13
Tadalafil 14 39 12
Teriflunomide 14 23 14
Varenicline 14 19 14
Vonoprazan 14 29 13
Vortioxetine 14 20 13
Atomoxetine 13 16 10
Brexpiprazole 13 20 12
Brivaracetam 13 22 12
Citalopram 13 18 12
Eslicarbazepine 13 17 11
Febuxostat 13 29 12
Fluconazole 13 21 11
Glycopyrronium 13 23 6
Irbesartan 13 45 12
Lenalidomide 13 25 12
Metformin 13 38 12
Metoprolol 13 26 12
Olmesartan Medoxomil 13 25 13
Rizatriptan 13 17 13
Sacubitril 13 27 12
Tafamidis 13 17 13
Tenofovir Alafenamide 13 24 12
Valganciclovir 13 18 9
Vildagliptin 13 34 10
Voriconazole 13 29 13
Aripiprazole 12 44 12
Atazanavir 12 15 11
Bisoprolol 12 28 11
Bortezomib 12 19 11
Canagliflozin 12 21 11
Capecitabine 12 19 11
Cetirizine 12 33 12
Chlorthalidone 12 13 11
Desloratadine 12 26 11
Dexlansoprazole 12 16 12
Fexofenadine 12 36 11
Ondansetron 12 24 10
Oseltamivir 12 23 12
Pioglitazone 12 14 11
Rifaximin 12 19 12
Risperidone 12 25 11
Rivastigmine 12 17 11
Sugammadex 12 35 12
Topiramate 12 16 11
Tramadol 12 25 12
Trazodone 12 16 11
Valaciclovir 12 17 10
Valacyclovir 12 17 10
Ziprasidone 12 14 11
Zolmitriptan 12 14 11
Dasatinib 11 22 11
Dextromethorphan 11 21 11
Dronedarone 11 14 11
Eltrombopag 11 22 11
Entacapone 11 14 9
Gabapentin 11 34 11
Imatinib 11 20 11
Meloxicam 11 28 10
Milnacipran 11 13 10
Palbociclib 11 23 11
Pramipexole 11 23 11
Saxagliptin 11 18 9
Sumatriptan 11 16 10
Tamsulosin 11 26 10
Viloxazine 11 14 11
Zolpidem 11 16 11
Allopurinol 10 21 10
Betahistine 10 20 4
Darifenacin 10 10 9
Elagolix 10 19 9
Erlotinib 10 16 9
Eszopiclone 10 13 9
Fenofibrate 10 25 10
Ferric Carboxymaltose 10 18 7
Fesoterodine 10 11 8
Finerenone 10 18 9
Gemcitabine 10 16 8
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
Pemetrexed 10 22 9
Prasugrel 10 11 10
Raloxifene 10 15 9
Ramipril 10 20 9
Ritonavir 10 16 10
Ruxolitinib 10 14 10
Terbinafine 10 27 10
Vilazodone 10 11 9
Abacavir 9 16 9
Albendazole 9 15 9
Aprepitant 9 16 8
Azilsartan Medoxomil 9 19 9
Bilastine 9 16 8
Buspirone 9 11 8
Cariprazine 9 13 9
Cefixime 9 26 7
Dabigatran Etexilate Mesilate 9 12 9
Efavirenz 9 12 9
Efinaconazole 9 16 9
Emtricitabine 9 16 9
Erythromycin 9 22 9
Fingolimod 9 17 9
Fosaprepitant 9 17 9
Glimepiride 9 26 8
Hydroxychloroquine 9 18 8
Icatibant 9 14 8
Letrozole 9 14 7
Levofloxacin 9 48 9
Lidocaine 9 20 5
Loratadine 9 23 8
Mirtazapine 9 17 8
Nebivolol 9 25 8
Olaparib 9 19 9
Pomalidomide 9 17 8
Prucalopride 9 13 8
Repaglinide 9 14 8
Semaglutide 9 61 8
Sorafenib 9 14 9
Tofacitinib 9 28 9
Tolvaptan 9 15 8
Torasemide 9 19 6
Vardenafil 9 14 6
Abiraterone 8 22 8
Acyclovir 8 39 7
Albuterol 8 24 7
Alendronic Acid 8 11 7
Atovaquone 8 10 8
Azithromycin 8 25 8
Bictegravir 8 10 7
Cefuroxime 8 29 8
Chlorpromazine 8 9 7
Colchicine 8 19 8
Dorzolamide 8 12 7

Showing the 200 molecules with the most India-based makers, of 406. 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?
301 distinct manufacturers based in India hold an active regulatory filing for at least one of the 406 molecules covered here, and 229 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?
142 of the 301 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 239 of 406 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 123 United States 11 Italy 2

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