Suppliers / Polypeptide

Polypeptide

Spain Updated 9 July 2026

The public registers hold a second record for Polypeptide. The fuller profile, with 27 active US DMFs and 8 valid CEPs, is at PolyPeptide. Figures on this page cover only this record.

Polypeptide is an API manufacturer based in Spain. It holds 8 active US drug master files across a filed portfolio of 3 molecules. Its GMP standing is certified by AEMPS (ES).

8
active US DMFs
0
valid CEPs
2
registered plants
0
filings across 0 regulators

Registered plants

Site FDA FEI
Braine-L'Alleud, Belgium Not on file
Valencia, Spain Not on file

What they file, and where

Molecule Regulators Docs
Semaglutide US FDA 4
Exenatide US FDA 2
Tertomotide US FDA 2

Also appears on these molecule pages

Exenatide API Semaglutide API

Filings and GMP by regulator

Regulator Filings GMP certificates
AEMPS (ES) None 1

Questions about Polypeptide

Does Polypeptide hold a US DMF or a CEP?
Polypeptide holds 8 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.
Where does Polypeptide manufacture?
2 registered sites are on record, in Belgium and Spain (Braine-l'alleud and Valencia). Every site is listed on this page with the register it came from.
What does Polypeptide make?
3 molecules are on record against Polypeptide, including Semaglutide, Exenatide and Tertomotide. Each links through to that molecule's full manufacturer list.
Which regulators recognise Polypeptide's GMP?
Current GMP certificates are on record from AEMPS (ES). 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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Sources on this page

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