Suppliers / Apicore Us

Apicore Us

United States Updated 9 July 2026

The public registers hold a second record for Apicore Us. The fuller profile, with 35 active US DMFs and 1 valid CEPs, is at Apicore. Figures on this page cover only this record.

Apicore Us is an API manufacturer based in United States. It holds 4 active US drug master files and one valid CEP across a filed portfolio of 4 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 2 April 2025 as NAI.

4
active US DMFs
1
valid CEPs
2
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
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 2 April 2025 NAI US FDA
  • 9 December 2019 NAI US FDA
  • 10 October 2017 NAI US FDA
  • 18 July 2016 VAI US FDA
  • 17 May 2013 VAI US FDA
  • 20 September 2011 VAI US FDA
  • 14 July 2010 NAI US FDA
  • 15 December 2008 VAI US FDA

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

Registered plants

Site FDA FEI
Somerset, United States Not on file
East Windsor Township, United States 3004864046

What they file, and where

Molecule Regulators Docs
Busulfan EDQM, US FDA 2
Bexarotene US FDA 1
Bortezomib US FDA 1
Tirzepatide US FDA 1

Also appears on these molecule pages

Bexarotene API Bortezomib API Busulfan API Tirzepatide API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Apicore Us

Does Apicore Us hold a US DMF or a CEP?
Apicore Us holds 4 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 Us FDA-registered?
One site operated by Apicore Us 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 Apicore Us's last inspection go?
The most recent inspection on record closed on 2 April 2025 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Apicore Us manufacture?
2 registered sites are on record, in United States (Somerset and East Windsor Township). Every site is listed on this page with the register it came from.
What does Apicore Us make?
4 molecules are on record against Apicore Us, including Busulfan, Bexarotene, Bortezomib and Tirzepatide. Each links through to that molecule's full manufacturer list.
Which regulators recognise Apicore Us's GMP?
Current GMP certificates are on record from US FDA. 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 NAI, on 2 April 2025.

Comparable suppliers

MSN Laboratories shares 2 molecules Hetero shares 2 molecules Dr Reddy's Laboratories shares 2 molecules Shilpa Pharma Lifesciences shares 2 molecules Shivalik Rasayan 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