AP
ALP Pharm Beijing Co., Ltd.
Manufacturer · Beijing, China
Overview
ALP Pharm Beijing was set up in 2006 and since 2007 has had APIs manufactured in partner facilities, acting as DMF holder and controlling manufacturing and quality points for ANDA and MA holders. A US affiliate, ALP Pharmaceutical Inc, handles FDA regulatory communication. It holds active US Type II DMFs for Bivalirudin, Cetrorelix, Difelikefalin, Eptifibatide, Exenatide, Goserelin, Lanreotide, Leuprolide, Liraglutide, Octreotide, Plecanatide, Semaglutide, Tirzepatide. Its site says partner plants passed FDA or EU inspections, but names no site, so regulator GMP evidence was not confirmed.
Capabilities
- DMF ownership and filing
- Contract-site manufacturing oversight
- Regulatory affairs (US/EU)
- Generic peptide API supply
Quality signals
| GMP evidence | Not found |
|---|---|
| Certificates of analysis | Not found |
| Third-party testing | Not found |
| ISO certification | Not found |
| Makes own product | Yes, in-house production |