Suppliers / Phyton Biotech

Phyton Biotech

Canada Updated 9 July 2026

Phyton Biotech is a contract manufacturer based in Canada. It holds 2 active US drug master files and 3 valid CEPs across a filed portfolio of 2 molecules. Its GMP standing is certified by ZLG (DE) and US FDA. Its most recent recorded inspection, by US FDA, closed on 19 October 2024 as VAI.

2
active US DMFs
3
valid CEPs
4
registered plants 2 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 19 October 2024 VAI US FDA
  • 29 March 2023 VAI US FDA
  • 20 February 2020 VAI US FDA
  • 28 August 2019 NAI US FDA
  • 15 September 2017 NAI US FDA
  • 15 July 2016 VAI US FDA
  • 24 October 2014 VAI US FDA
  • 27 September 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
Delta, Canada Not on file
Canada, Canada 3006110823
Ahrensburg, Germany Not on file
Germany, Germany 3002807883

What they file, and where

Molecule Regulators Docs
Docetaxel EDQM, SFDA (Saudi Arabia), US FDA 4
Paclitaxel EDQM, SFDA (Saudi Arabia), US FDA 4

Also appears on these molecule pages

Docetaxel contract manufacturing Paclitaxel contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
ZLG (DE) None 4
US FDA None 1

Questions about Phyton Biotech

Does Phyton Biotech hold a US DMF or a CEP?
Phyton Biotech holds 2 active US drug master files and 3 valid CEPs. 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 Phyton Biotech FDA-registered?
2 sites operated by Phyton Biotech 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 Phyton Biotech's last inspection go?
The most recent inspection on record closed on 19 October 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Phyton Biotech manufacture?
4 registered sites are on record, in Canada and Germany (Delta, Canada and Ahrensburg among others). Every site is listed on this page with the register it came from.
What does Phyton Biotech make?
2 molecules are on record against Phyton Biotech, including Docetaxel and Paclitaxel. Each links through to that molecule's full manufacturer list.
Which regulators recognise Phyton Biotech's GMP?
Current GMP certificates are on record from ZLG (DE) and 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 VAI, on 19 October 2024.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates