Suppliers / Bristol Myers Squibb Manufacturing

Bristol Myers Squibb Manufacturing

United States BMY Updated 9 July 2026

Bristol Myers Squibb Manufacturing is an API and finished-dose manufacturer based in United States. It appears in 534 regulatory filings across 4 regulators, without an active US DMF or CEP on file. Its filings concentrate with ANVISA (Brazil), US FDA and INFARMED (PT). Its GMP standing is certified by US FDA and MHRA (UK). Its most recent recorded inspection, by US FDA, closed on 8 July 2025 as VAI.

0
active US DMFs
0
valid CEPs
5
registered plants 1 with an FDA FEI number
534
filings across 4 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 8 July 2025 VAI US FDA
  • 10 January 2020 VAI US FDA
  • 5 April 2017 VAI US FDA
  • 26 June 2015 NAI US FDA
  • 20 June 2013 VAI US FDA

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

Registered plants

Site FDA FEI
SAO PAULO, Brazil Not on file
São Paulo, Brazil Not on file
HUMACAO, Puerto Rico Not on file
Terrugem, Portugal Not on file
Devens, United States 3008455069

What they file, and where

Molecule Regulators Docs
Apixaban SFDA (Saudi Arabia) 1

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Filings and GMP by regulator

Regulator Filings GMP certificates
ANVISA (Brazil) 232 None
US FDA 174 1
INFARMED (PT) 126 None
DIGEMAPS (DO) 2 None
MHRA (UK) None 1

Scale

Year Revenue Exports Destinations
2025 $48.2B Not reported Not reported
2024 $48.3B Not reported Not reported
2023 $45.0B Not reported Not reported

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 We do not publish the identity of any buyer.

Questions about Bristol Myers Squibb Manufacturing

Does Bristol Myers Squibb Manufacturing hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Bristol Myers Squibb Manufacturing. It does have 534 filings with 4 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Bristol Myers Squibb Manufacturing FDA-registered?
One site operated by Bristol Myers Squibb Manufacturing 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 Bristol Myers Squibb Manufacturing's last inspection go?
The most recent inspection on record closed on 8 July 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Bristol Myers Squibb Manufacturing manufacture?
5 registered sites are on record, in Brazil, Puerto Rico, Portugal and United States (SAO Paulo, São Paulo and Humacao among others). Every site is listed on this page with the register it came from.
What does Bristol Myers Squibb Manufacturing make?
1 molecule is on record against Bristol Myers Squibb Manufacturing, including Apixaban. Each links through to that molecule's full manufacturer list.
Which regulators recognise Bristol Myers Squibb Manufacturing's GMP?
Current GMP certificates are on record from US FDA 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 8 July 2025.

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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
Company filings
Revenue as reported