Suppliers / BioVectra

BioVectra

Canada Updated 9 July 2026

BioVectra is an API and finished-dose manufacturer based in Canada. It holds one active US drug master file. Its most recent recorded inspection, by US FDA, closed on 26 August 2022 as VAI.

1
active US DMFs
0
valid CEPs
2
registered plants 2 with an FDA FEI number
6
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 26 August 2022 VAI US FDA
  • 17 February 2017 VAI US FDA
  • 17 April 2015 VAI US FDA
  • 8 August 2013 NAI US FDA
  • 25 August 2010 NAI US FDA

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

Registered plants

Site FDA FEI
Canada, Canada 3004063541
Canada, Canada 3015684350

What they file, and where

Molecule Regulators Docs
Docetaxel US FDA 1

Also appears on these molecule pages

Dimethyl contract manufacturing Docetaxel API Methotrexate contract manufacturing Tirzepatide finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 6 None

Questions about BioVectra

Does BioVectra hold a US DMF or a CEP?
BioVectra holds 1 active US drug master file. 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 BioVectra FDA-registered?
2 sites operated by BioVectra 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 BioVectra's last inspection go?
The most recent inspection on record closed on 26 August 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does BioVectra manufacture?
2 registered sites are on record, in Canada (Canada among others). Every site is listed on this page with the register it came from.
What does BioVectra make?
1 molecule is on record against BioVectra, including Docetaxel. Each links through to that molecule's full manufacturer list.
Where does BioVectra file?
Filings are on record with MINSA (CR), 6 in total.

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 26 August 2022.

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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