Suppliers / Avantor Performance Materials, S.A. de C.V

Avantor Performance Materials, S.A. de C.V

Mexico Updated 9 July 2026

Avantor Performance Materials, S.A. de C.V is an API manufacturer based in Mexico. It holds 5 active US drug master files across a filed portfolio of 5 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 27 May 2025 as VAI.

5
active US DMFs
0
valid CEPs
2
registered plants 2 with an FDA FEI number
2
filings across 1 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

  • 27 May 2025 VAI US FDA
  • 13 November 2024 VAI US FDA
  • 14 April 2021 VAI US FDA
  • 12 August 2019 NAI US FDA
  • 3 August 2018 NAI US FDA
  • 24 October 2016 VAI US FDA
  • 17 July 2015 VAI US FDA
  • 15 November 2013 NAI US FDA

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

Registered plants

Site FDA FEI
Phillipsburg, United States 2220077
Paris, United States 1045125

What they file, and where

Molecule Regulators Docs
Dipotassium Phosphate US FDA 1
Magnesium US FDA 1
Monopotassium Phosphate US FDA 1
Trehalose US FDA 1
Zinc US FDA 1

Filings and GMP by regulator

Regulator Filings GMP certificates
EEC_EAEU 2 None
US FDA None 2

Questions about Avantor Performance Materials, S.A. de C.V

Does Avantor Performance Materials, S.A. de C.V hold a US DMF or a CEP?
Avantor Performance Materials, S.A. de C.V holds 5 active US drug master files. 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 Avantor Performance Materials, S.A. de C.V FDA-registered?
2 sites operated by Avantor Performance Materials, S.A. de C.V 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 Avantor Performance Materials, S.A. de C.V's last inspection go?
The most recent inspection on record closed on 27 May 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Avantor Performance Materials, S.A. de C.V manufacture?
2 registered sites are on record, in United States (Phillipsburg and Paris). Every site is listed on this page with the register it came from.
What does Avantor Performance Materials, S.A. de C.V make?
5 molecules are on record against Avantor Performance Materials, S.A. de C.V, including Dipotassium Phosphate, Magnesium, Monopotassium Phosphate and Trehalose. Each links through to that molecule's full manufacturer list.
Which regulators recognise Avantor Performance Materials, S.A. de C.V'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 VAI, on 27 May 2025.

Sources on this page

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