Suppliers / Apicore

Apicore

India 250 employees reconciled across 3 public records · 2 entities Updated 9 July 2026

Apicore is an API manufacturer based in India. It holds 35 active US drug master files and one valid CEP. Its GMP standing is certified by US FDA, CDSCO (India) and EDQM. Its most recent recorded inspection, by US FDA, closed on 12 December 2025 as VAI. Customs aggregates show $15.4M of exports covering 148 molecules to 18 destinations in 2025.

35
active US DMFs
1
valid CEPs
6
registered plants 4 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 confirmed
Inspections
7 of 7 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 12 December 2025 VAI US FDA
  • 2 April 2025 NAI US FDA
  • 5 May 2023 VAI US FDA
  • 9 December 2019 NAI US FDA
  • 8 November 2019 NAI US FDA
  • 25 January 2018 VAI US FDA
  • 10 October 2017 NAI US FDA
  • 18 July 2016 VAI US FDA
  • 25 March 2016 VAI US FDA
  • 13 June 2014 VAI US FDA
  • 17 May 2013 VAI US FDA
  • 20 September 2011 VAI US FDA

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

Registered plants

Site FDA FEI
Anakapalli, India 3012575874
Hyderabad, India 3007136165
Vadodara, India 3006767695
tal padravadodara, India Not on file
Somerset, United States Not on file
East Windsor Township, United States 3004864046

What they file, and where

Molecule Regulators Docs
Plerixafor SFDA (Saudi Arabia), US FDA 3
Belzutifan US FDA 2
Busulfan EDQM, US FDA 2
Cevimeline US FDA 2
Cyclophosphamide US FDA 2
Ferric Carboxymaltose US FDA 2
Ferumoxytol US FDA 2
Flibanserin US FDA 2
Fluorescein US FDA 2
Ganirelix US FDA 2
Show all 35 molecules on file
Lurbinectedin US FDA 2
Metyrosine US FDA 2
Miglustat SFDA (Saudi Arabia), US FDA 2
Selegiline US FDA 2
Semaglutide US FDA 2
Trabectedin US FDA 2
Alcaftadine US FDA 1
Bexarotene US FDA 1
Bortezomib US FDA 1
Cetrorelix US FDA 1
Degarelix US FDA 1
Dimetindene SFDA (Saudi Arabia) 1
Indocyanine Green US FDA 1
Maralixibat US FDA 1
Oseltamivir US FDA 1
Penicillamine US FDA 1
Pentosan Polysulfate Sodium US FDA 1
Perphenazine US FDA 1
Phentolamine US FDA 1
Raltegravir US FDA 1
Safinamide US FDA 1
Sugammadex SFDA (Saudi Arabia) 1
Tetraferric Tricitrate Decahydrate US FDA 1
Tirzepatide US FDA 1
Vosoritide US FDA 1

Also appears on these molecule pages

Show 3 more molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 2
CDSCO (India) None 2
EDQM None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $875K 4
2025 Not reported $15.4M 18
2024 Not reported $9.3M 11
2023 Not reported $7.1M 15

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

Questions about Apicore

Does Apicore hold a US DMF or a CEP?
Apicore holds 35 active US drug master files and 1 valid CEP. 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 Apicore FDA-registered?
4 sites operated by Apicore 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 Apicore's last inspection go?
The most recent inspection on record closed on 12 December 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 15 inspections are on file.
Where does Apicore manufacture?
6 registered sites are on record, in India and United States (Anakapalli, Hyderabad and Vadodara among others). Every site is listed on this page with the register it came from.
What does Apicore make?
35 molecules are on record against Apicore, including Plerixafor, Belzutifan, Busulfan and Cevimeline. Each links through to that molecule's full manufacturer list.
Which regulators recognise Apicore's GMP?
Current GMP certificates are on record from US FDA, CDSCO (India) and EDQM. 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 12 December 2025.

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