Suppliers / PolyPeptide

PolyPeptide

Sweden reconciled across 7 public records · 4 entities Updated 9 July 2026

PolyPeptide is an API manufacturer based in Sweden. It holds 27 active US drug master files and 8 valid CEPs across a filed portfolio of 19 molecules. Its GMP standing is certified by ANSM (FR), EDQM and US FDA, among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 15 May 2025 as VAI.

27
active US DMFs
8
valid CEPs
12
registered plants 5 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 confirmed
Inspections
8 of 8 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 15 May 2025 VAI US FDA
  • 23 January 2025 VAI US FDA
  • 22 November 2024 VAI US FDA
  • 4 July 2024 VAI US FDA
  • 10 May 2024 VAI US FDA
  • 19 November 2021 NAI US FDA
  • 12 September 2019 NAI US FDA
  • 16 April 2019 NAI US FDA
  • 10 April 2019 VAI US FDA
  • 19 July 2017 VAI US FDA
  • 11 August 2016 NAI US FDA
  • 27 May 2016 NAI US FDA

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

Registered plants

Site FDA FEI
Braine-L'Alleud, Belgium Not on file
Braine-L'Alleud, Belgium Not on file
Valencia, Spain Not on file
France, France 3007417577
Strasbourg, France Not on file
Thane, India 3009051788

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Desmopressin EDQM, SFDA (Saudi Arabia), US FDA 5
Octreotide EDQM, SFDA (Saudi Arabia), US FDA 4
Exenatide US FDA 3
Leuprolide EDQM, US FDA 3
Linaclotide SFDA (Saudi Arabia), US FDA 3
Vasopressin SFDA (Saudi Arabia), US FDA 3
Semaglutide US FDA 2
Teriparatide SFDA (Saudi Arabia), US FDA 2
Terlipressin EDQM, US FDA 2
Acyline US FDA 1
Show all 19 molecules on file
Calcitonin (Salmon) EDQM 1
Deslorelin US FDA 1
Eptifibatide US FDA 1
Felypressin EDQM 1
Glepaglutide US FDA 1
Liraglutide US FDA 1
Somatostatin EDQM 1
Tertomotide US FDA 1
Ｄｉｆｅｌｉｋｅｆａｌｉｎ PMDA (Japan) 1

Also appears on these molecule pages

Desmopressin API Eptifibatide API Exenatide API Leuprolide API Linaclotide API Liraglutide API Octreotide API Somatostatin API Teriparatide API Terlipressin API Vasopressin API

Filings and GMP by regulator

Regulator Filings GMP certificates
ANSM (FR) None 28
EDQM None 8
US FDA None 5
MFDS (Korea) None 2
EMA None 1
AEMPS (ES) None 1

Questions about PolyPeptide

Does PolyPeptide hold a US DMF or a CEP?
PolyPeptide holds 27 active US drug master files and 8 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 PolyPeptide FDA-registered?
5 sites operated by PolyPeptide 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 PolyPeptide's last inspection go?
The most recent inspection on record closed on 15 May 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 24 inspections are on file.
Where does PolyPeptide manufacture?
12 registered sites are on record, in Belgium, Spain, France and India (Braine-l'alleud, Valencia and France among others). Every site is listed on this page with the register it came from.
What does PolyPeptide make?
19 molecules are on record against PolyPeptide, including Desmopressin, Octreotide, Exenatide and Leuprolide. Each links through to that molecule's full manufacturer list.
Which regulators recognise PolyPeptide's GMP?
Current GMP certificates are on record from ANSM (FR), EDQM, US FDA, MFDS (Korea), EMA and 1 more. 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 15 May 2025.

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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