Suppliers / Apothecon Pharmaceuticals

Apothecon Pharmaceuticals

India 445 employees 2 duplicate records merged Updated 9 July 2026

Apothecon Pharmaceuticals is an API manufacturer based in India. It appears in 4 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with MINSA (CR), NCELS (KZ) and EDE (AE). Its GMP standing is certified by CDSCO (India), EMA and MFDS (Korea), among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 27 January 2023 as VAI. Customs aggregates show $9.7M of exports covering 152 molecules to 21 destinations in 2025.

0
active US DMFs
0
valid CEPs
5
registered plants 1 with an FDA FEI number
4
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 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

  • 27 January 2023 VAI US FDA
  • 24 August 2018 VAI US FDA
  • 14 October 2015 NAI US FDA

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

Registered plants

Site FDA FEI
Vadodara, United Arab Emirates Not on file
Vadodara, India 3008405956
GUJARAT, India Not on file
tal padravadodara, India Not on file
anand, India Not on file

What they file, and where

Molecule Regulators Docs
Benzatropine SFDA (Saudi Arabia) 1
Benzoic Acid SFDA (Saudi Arabia) 1
Carglumic Acid SFDA (Saudi Arabia) 1
Carmustine SFDA (Saudi Arabia) 1
Fomepizole SFDA (Saudi Arabia) 1
Penicillamine SFDA (Saudi Arabia) 1
Sevelamer Carbonate SFDA (Saudi Arabia) 1
Sodium Bicarbonate SFDA (Saudi Arabia) 1
Triethylenetetramine SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Aprepitant contract manufacturing Bendamustine contract manufacturing Benzatropine API Carglumic Acid API Carmustine contract manufacturing Colesevelam contract manufacturing Colestipol contract manufacturing Cyclophosphamide contract manufacturing Fomepizole contract manufacturing Fosaprepitant contract manufacturing Hydralazine contract manufacturing Melphalan contract manufacturing
Show 6 more molecule pages
Miglustat contract manufacturing Nicardipine contract manufacturing Penicillamine contract manufacturing Ropivacaine contract manufacturing Sevelamer contract manufacturing Triethylenetetramine API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 2 None
NCELS (KZ) 1 None
EDE (AE) 1 None
CDSCO (India) None 4
EMA None 2
MFDS (Korea) None 2
ANVISA (Brazil) None 1
MHRA (UK) None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $392K 7
2025 Not reported $9.7M 21
2024 Not reported $5.3M 17
2023 Not reported $3.2M 24

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

Questions about Apothecon Pharmaceuticals

Does Apothecon Pharmaceuticals hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Apothecon Pharmaceuticals. It does have 4 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Apothecon Pharmaceuticals FDA-registered?
One site operated by Apothecon Pharmaceuticals 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 Apothecon Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 27 January 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Apothecon Pharmaceuticals manufacture?
5 registered sites are on record, in United Arab Emirates and India (Vadodara, Gujarat and Tal Padravadodara among others). Every site is listed on this page with the register it came from.
What does Apothecon Pharmaceuticals make?
9 molecules are on record against Apothecon Pharmaceuticals, including Benzatropine, Benzoic Acid, Carglumic Acid and Carmustine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Apothecon Pharmaceuticals's GMP?
Current GMP certificates are on record from CDSCO (India), EMA, MFDS (Korea), ANVISA (Brazil) and MHRA (UK). 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 27 January 2023.

Comparable suppliers

Navinta shares 4 molecules Apitoria Pharma shares 2 molecules Biophore India Pharmaceuticals shares 2 molecules MSN Laboratories shares 1 molecule Dr Reddy's Laboratories shares 1 molecule

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