Suppliers / Bajaj Healthcare

Bajaj Healthcare

India 577 employees reconciled across 7 public records · 5 entities Updated 9 July 2026

Bajaj Healthcare is an API and finished-dose manufacturer based in India. It holds 3 active US drug master files and 8 valid CEPs across a filed portfolio of 10 molecules. Its filings concentrate with CDSCO (India), US FDA and MINSA (CR). Its GMP standing is certified by CDSCO (India), US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 25 August 2025 as VAI. Customs aggregates show $25.6M of exports covering 563 molecules to 66 destinations in 2025.

3
active US DMFs
8
valid CEPs
12
registered plants 3 with an FDA FEI number
21
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 25 August 2025 VAI US FDA
  • 4 December 2024 VAI US FDA
  • 1 October 2019 VAI US FDA
  • 16 October 2015 VAI US FDA

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

Registered plants

Site FDA FEI
Thane (West), India Not on file
Bharuch, India Not on file
Thane, India Not on file
at, India Not on file
manjusar 391 775 vadodara, India Not on file
Dist. Vadodara, India Not on file

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Calcium US FDA 1
Calcium Dobesilate EDQM 1
Carbamazepine EDQM 1
Chlorhexidine Digluconate EDQM 1
Cyclizine EDQM 1
Metronidazole EDQM 1
Oxcarbazepine EDQM 1
Rivaroxaban EDQM 1
Theobromine US FDA 1
Trazodone EDQM 1

Also appears on these molecule pages

Calci contract manufacturing Carbamazepine contract manufacturing Chlorhexidine contract manufacturing Deferasirox contract manufacturing Diosmin contract manufacturing Fosfomycin contract manufacturing Hesperidin contract manufacturing Metronidazole API Oxcarbazepine contract manufacturing Pimavanserin finished dose Sitagliptin contract manufacturing Ticagrelor contract manufacturing
Show 3 more molecule pages
Trazodone API Vildagliptin contract manufacturing Rivaroxaban API

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 12 12
US FDA 6 1
MINSA (CR) 3 None
EMA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $2.7M 34
2025 Not reported $25.6M 66
2024 Not reported $10.1M 62
2023 Not reported $13.0M 60

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

Questions about Bajaj Healthcare

Does Bajaj Healthcare hold a US DMF or a CEP?
Bajaj Healthcare holds 3 active US drug master files and 8 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 Bajaj Healthcare FDA-registered?
3 sites operated by Bajaj Healthcare 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 Bajaj Healthcare's last inspection go?
The most recent inspection on record closed on 25 August 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Bajaj Healthcare manufacture?
12 registered sites are on record, in India and United States (Thane (west), Bharuch and Thane among others). Every site is listed on this page with the register it came from.
What does Bajaj Healthcare make?
10 molecules are on record against Bajaj Healthcare, including Calcium, Calcium Dobesilate, Carbamazepine and Chlorhexidine Digluconate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Bajaj Healthcare's GMP?
Current GMP certificates are on record from CDSCO (India), US FDA and EMA. 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 25 August 2025.

Comparable suppliers

Jubilant Biosys shares 2 molecules Dasami Lab shares 2 molecules CTX Lifesciences shares 2 molecules Amoli Organics shares 2 molecules F.I.S. Fabbrica Italiana Sintetici shares 2 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