Suppliers / Ajanta Pharma

Ajanta Pharma

India AJANTPHARM.NS 95 employees 3 duplicate records merged Updated 9 July 2026

Ajanta Pharma is an API and finished-dose manufacturer based in India. It holds 4 active US drug master files across a filed portfolio of 4 molecules. Its filings concentrate with US FDA, TMDA (TZ) and UZPHARM (UZ). Its GMP standing is certified by CDSCO (India), UZPHARM (UZ) and FDA (GH), among 7 authorities. Its most recent recorded inspection, by US FDA, closed on 5 March 2024 as NAI. Customs aggregates show $239.1M of exports covering 6,046 molecules to 59 destinations in 2025.

4
active US DMFs
0
valid CEPs
12
registered plants 2 with an FDA FEI number
541
filings across 15 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 5 March 2024 NAI US FDA
  • 23 June 2023 NAI US FDA
  • 28 June 2019 VAI US FDA
  • 22 June 2019 VAI US FDA
  • 9 February 2018 NAI US FDA
  • 7 February 2017 VAI US FDA
  • 20 March 2015 VAI US FDA
  • 6 September 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
PAITHAN, India Not on file
Chhatrapati Sambhajinagar, India 3006785788
at indradtal kadimehsana 382 715, India Not on file
vapivapi 396 195valsad, India Not on file
ankleshwar 393 002bharuch, India Not on file
vadoda ra, India Not on file

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Duloxetine US FDA 1
Ranolazine US FDA 1
Valganciclovir US FDA 1
Voriconazole US FDA 1

Also appears on these molecule pages

Show 100 more molecule pages
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Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 164 2
TMDA (TZ) 138 1
UZPHARM (UZ) 50 7
ZAMRA (ZM) 46 None
JFDA (JO) 31 None
DAV (Vietnam) 28 None
CDSCO (India) None 11
FDA (GH) None 3
NAFDAC (NG) None 3
MHRA (UK) None 1

Scale

Year Revenue Exports Destinations
2026 YTD $625.8M $720K 1
2025 $533.4M $239.1M 59
2024 $503.0M $316.9M 62
2023 Not reported $292.9M 61

Export figures are customs aggregates. We do not publish the identity of any buyer. Revenue shown in US dollars, converted from the reported currency.

Questions about Ajanta Pharma

Does Ajanta Pharma hold a US DMF or a CEP?
Ajanta Pharma holds 4 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 Ajanta Pharma FDA-registered?
2 sites operated by Ajanta Pharma 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 Ajanta Pharma's last inspection go?
The most recent inspection on record closed on 5 March 2024 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Ajanta Pharma manufacture?
12 registered sites are on record, in India (Paithan, Chhatrapati Sambhajinagar and At Indradtal Kadimehsana 382 715 among others). Every site is listed on this page with the register it came from.
What does Ajanta Pharma make?
4 molecules are on record against Ajanta Pharma, including Duloxetine, Ranolazine, Valganciclovir and Voriconazole. Each links through to that molecule's full manufacturer list.
Which regulators recognise Ajanta Pharma's GMP?
Current GMP certificates are on record from CDSCO (India), UZPHARM (UZ), FDA (GH), NAFDAC (NG), US FDA and 2 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

  • 8 active litigation matters are on record.
  • The most recent inspection outcome was NAI, on 5 March 2024.

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
Company filings
Revenue as reported