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SL

Suzhou Lixin Pharmaceutical Co., Ltd.

CDMO · Suzhou, China

Overview

Suzhou Lixin Pharmaceutical has made APIs and intermediates since 2000, mainly in oncology, cardiovascular, antiviral and digestive areas, and offers CDMO and CMO services. Its site reports eight EDQM CEPs and an FDA first-generic approval for nilotinib in 2022, and says the related Shandong Lixin Pharmaceutical site passed an FDA cGMP inspection in 2023; that inspection was not of the Suzhou entity, so regulatorGmp is left false. The FDA DMF list shows an active Type II DMF for semaglutide.

Capabilities

  • Semaglutide API
  • Oncology and cardiovascular APIs
  • Advanced intermediates
  • CDMO/CMO services

Quality signals

GMP evidenceNot found
Certificates of analysisNot found
Third-party testingNot found
ISO certificationNot found
Makes own productYes, in-house production
In-House ProductionCDMO ServicesUS DMF HolderAPIs & Intermediates

Sources

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