Suppliers / Biocon

Biocon

India 2 duplicate records merged Updated 9 July 2026

Biocon is an API and finished-dose manufacturer based in India. It holds 69 active US drug master files and 29 valid CEPs. Its filings concentrate with US FDA, AIFA (IT) and EDE (AE). Its GMP standing is certified by ANVISA (Brazil), EMA and CDSCO (India), among 8 authorities. Its most recent recorded inspection, by US FDA, closed on 3 September 2025 as VAI.

69
active US DMFs
29
valid CEPs
12
registered plants 3 with an FDA FEI number
429
filings across 29 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 confirmed
Inspections
6 of 8 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 3 September 2025 VAI US FDA
  • 20 September 2024 VAI US FDA
  • 26 July 2024 VAI US FDA
  • 21 June 2024 VAI US FDA
  • 2 June 2023 NAI US FDA
  • 19 May 2023 NAI US FDA
  • 26 February 2020 VAI US FDA
  • 24 January 2020 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Bengaluru, United Arab Emirates Not on file
Johor, United Arab Emirates Not on file
Iskandar Puteri, United Arab Emirates Not on file
Bangalore, Colombia Not on file
EDGWARE, United Kingdom Not on file
Bangalore, India Not on file

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Rosuvastatin EDQM, SFDA (Saudi Arabia), US FDA 11
Everolimus EDQM, SFDA (Saudi Arabia), US FDA 10
Sitagliptin EDQM, SFDA (Saudi Arabia), US FDA 7
Tacrolimus EDQM, SFDA (Saudi Arabia), US FDA 7
Fingolimod EDQM, SFDA (Saudi Arabia), US FDA 6
Mycophenolate Mofetil EDQM, SFDA (Saudi Arabia), US FDA 5
Posaconazole SFDA (Saudi Arabia), US FDA 5
Simvastatin EDQM, SFDA (Saudi Arabia), US FDA 5
Fluvastatin Sodium EDQM 4
Atorvastatin SFDA (Saudi Arabia), US FDA 3
Show all 30 molecules on file
Deferasirox EDQM, SFDA (Saudi Arabia), US FDA 3
Fluvastatin US FDA 3
Linagliptin SFDA (Saudi Arabia), US FDA 3
Mycophenolic Acid EDQM, SFDA (Saudi Arabia), US FDA 3
Pioglitazone SFDA (Saudi Arabia), US FDA 3
Pravastatin EDQM, US FDA 3
Teriflunomide EDQM, SFDA (Saudi Arabia), US FDA 3
Dapagliflozin US FDA 2
Dasatinib SFDA (Saudi Arabia), US FDA 2
Lenalidomide SFDA (Saudi Arabia), US FDA 2
Micafungin SFDA (Saudi Arabia), US FDA 2
Mirabegron EDQM, US FDA 2
Orlistat SFDA (Saudi Arabia), US FDA 2
Repaglinide EDQM, US FDA 2
Rivaroxaban EDQM, US FDA 2
Sacubitril SFDA (Saudi Arabia), US FDA 2
Sirolimus SFDA (Saudi Arabia), US FDA 2
Vildagliptin SFDA (Saudi Arabia), US FDA 2
Anidulafungin US FDA 1
Apixaban US FDA 1

Also appears on these molecule pages

Aminocaproic Acid finished dose Apixaban API Atorvastatin API Brinzolamide API Cabozantinib API Dabigatran Etexilate API Dabigatran Etexilate Mesilate API Dapagliflozin API Dapagliflozin Propanediol finished dose Daptomycin contract manufacturing Dasatinib API Deferasirox API
Show 51 more molecule pages
Dimethyl finished dose Edoxaban API Eltrombopag API Empagliflozin API Enzalutamide API Esomeprazole finished dose Everolimus API Famotidine finished dose Fingolimod API Fluvastatin API Glatiramer finished dose Histidine finished dose Ivabradine API Ivacaftor API Lenalidomide API Linagliptin API Liraglutide API Lurasidone API Micafungin API Mirabegron API Mycophenolate Mofetil API Mycophenolic Acid API Nintedanib API Nitrofurantoin finished dose Olaparib API Orlistat API Oxcarbazepine finished dose Pimecrolimus API Pioglitazone API Posaconazole API Pravastatin API Prazosin finished dose Relugolix API Repaglinide API Rivaroxaban API Rosuvastatin API Sacubitril API Semaglutide API Sertraline finished dose Simvastatin API Sirolimus API Sitagliptin API Tacrolimus API Teduglutide API Teriflunomide API Ticagrelor API Tirzepatide API Trametinib API Travoprost API Valsartan API Vildagliptin API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 102 6
AIFA (IT) 68 None
EDE (AE) 31 None
CDSCO (India) 30 8
NPRA (MY) 30 None
EMA 29 9
ANVISA (Brazil) None 14
MHRA (UK) None 4
EAEU_EEC None 1
FDA (GH) None 1
INVIMA (CO) None 1

Questions about Biocon

Does Biocon hold a US DMF or a CEP?
Biocon holds 69 active US drug master files and 29 valid CEPs. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Biocon FDA-registered?
3 sites operated by Biocon carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Biocon's last inspection go?
The most recent inspection on record closed on 3 September 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Biocon manufacture?
12 registered sites are on record, in United Arab Emirates, Colombia, United Kingdom and India (Bengaluru, Johor and Iskandar Puteri among others). Every site is listed on this page with the register it came from.
What does Biocon make?
30 molecules are on record against Biocon, including Rosuvastatin, Everolimus, Sitagliptin and Tacrolimus. Each links through to that molecule's full manufacturer list.
Which regulators recognise Biocon's GMP?
Current GMP certificates are on record from ANVISA (Brazil), EMA, CDSCO (India), US FDA, MHRA (UK) and 3 more. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • 1 active litigation matter is on record.
  • The most recent inspection outcome was VAI, on 3 September 2025.

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates