Suppliers / Jubilant Biosys

Jubilant Biosys

India Updated 9 July 2026

Jubilant Biosys is an API manufacturer based in India. It holds 182 active US drug master files. Its GMP standing is certified by MFDS (Korea). Its most recent recorded inspection, by US FDA, closed on 13 December 2022 as VAI. Customs aggregates show $15.9M of exports covering 1,072 molecules to 36 destinations in 2025.

182
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 13 December 2022 VAI US FDA
  • 18 December 2018 OAI US FDA
  • 27 October 2017 VAI US FDA
  • 16 October 2015 NAI US FDA
  • 31 May 2012 VAI US FDA

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

Registered plants

Site FDA FEI
Mysuru, India 3003144728

What they file, and where

Molecule Regulators Docs
Esomeprazole US FDA 10
Azithromycin SFDA (Saudi Arabia), US FDA 5
Bupropion US FDA 4
Citalopram US FDA 4
Escitalopram US FDA 4
Oxcarbazepine US FDA 4
Paliperidone US FDA 4
Rivastigmine US FDA 4
Aprepitant SFDA (Saudi Arabia), US FDA 3
Alendronic Acid US FDA 2
Show all 30 molecules on file
Aliskiren US FDA 2
Apixaban US FDA 2
Apremilast US FDA 2
Aripiprazole US FDA 2
Atorvastatin US FDA 2
Azilsartan Medoxomil US FDA 2
Bosentan US FDA 2
Brexpiprazole US FDA 2
Carbamazepine US FDA 2
Cetirizine US FDA 2
Cinacalcet US FDA 2
Clopidogrel US FDA 2
Cyclobenzaprine US FDA 2
Dabigatran Etexilate US FDA 2
Darifenacin US FDA 2
Deferasirox US FDA 2
Dexlansoprazole US FDA 2
Donepezil US FDA 2
Duloxetine US FDA 2
Entacapone US FDA 2

Also appears on these molecule pages

Alendronic Acid API Aprepitant API Azilsartan Medoxomil API Azithromycin API Bosentan API Brexpiprazole API Bupropion API Carbamazepine API Cetirizine API Cinacalcet API Citalopram API Cyclobenzaprine API
Show 48 more molecule pages
Darifenacin API Deferasirox API Dexlansoprazole API Donepezil API Entacapone API Eprosartan API Eslicarbazepine API Febuxostat API Fexofenadine API Galantamine API Guanfacine API Lacosamide API Lamotrigine API Levocetirizine API Linezolid API Oxcarbazepine contract manufacturing Paliperidone API Paroxetine API Rabeprazole API Ranolazine API Repaglinide API Risedronic Acid API Rivastigmine API Rizatriptan API Ropivacaine API Simvastatin API Terazosin API Tramadol API Valaciclovir API Valacyclovir API Valsartan contract manufacturing Varenicline API Vilazodone API Vildagliptin API Voriconazole API Ziprasidone API Zoledronic Acid API Zolmitriptan API Zopiclone API Atorvastatin API Clopidogrel API Escitalopram API Esomeprazole API Duloxetine API Apixaban API Aripiprazole API Dabigatran Etexilate API Apremilast API

Filings and GMP by regulator

Regulator Filings GMP certificates
MFDS (Korea) None 2

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $7.6M 41
2025 Not reported $15.9M 36
2024 Not reported $3.2M 16
2023 Not reported $4.0M 14

Export figures are customs aggregates. We do not publish the identity of any buyer.

Questions about Jubilant Biosys

Does Jubilant Biosys hold a US DMF or a CEP?
Jubilant Biosys holds 182 active US drug master files. 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 Jubilant Biosys FDA-registered?
One site operated by Jubilant Biosys carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Jubilant Biosys's last inspection go?
The most recent inspection on record closed on 13 December 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file, of which 1 closed as OAI.
Where does Jubilant Biosys manufacture?
1 registered site is on record, in India (Mysuru). Every site is listed on this page with the register it came from.
What does Jubilant Biosys make?
30 molecules are on record against Jubilant Biosys, including Esomeprazole, Azithromycin, Bupropion and Citalopram. Each links through to that molecule's full manufacturer list.
Which regulators recognise Jubilant Biosys's GMP?
Current GMP certificates are on record from MFDS (Korea). 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

  • The most recent inspection outcome was VAI, on 13 December 2022.

Comparable suppliers

Apitoria Pharma shares 32 molecules Dr Reddy's Laboratories shares 26 molecules Matrix Pharmacorp shares 20 molecules Hetero shares 19 molecules Macleods Pharmaceuticals shares 19 molecules

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
Customs aggregates
Export values, molecule and destination counts