PolyPeptide Laboratories (Sweden) AB is an API manufacturer based in Sweden. It holds 17 active US drug master files and 8 valid CEPs across a filed portfolio of 15 molecules. Its GMP standing is certified by ANSM (FR), US FDA and MFDS (Korea), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 23 January 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Braine-L'Alleud, Belgium | Not on file |
| Strasbourg, France | Not on file |
| Thane, India | 3009051788 |
| Sweden, Sweden | 3002807004 |
| Limhamn, Sweden | Not on file |
| Malmö, Sweden | Not on file |
2 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Desmopressin | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Octreotide | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Leuprolide | EDQM, US FDA | 3 |
| Linaclotide | SFDA (Saudi Arabia), US FDA | 3 |
| Vasopressin | SFDA (Saudi Arabia), US FDA | 3 |
| Exenatide | US FDA | 2 |
| Teriparatide | SFDA (Saudi Arabia), US FDA | 2 |
| Terlipressin | EDQM, US FDA | 2 |
| 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 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| ANSM (FR) | None | 28 |
| US FDA | None | 3 |
| MFDS (Korea) | None | 2 |
| EMA | None | 1 |
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