Zhejiang Huahai Pharmaceutical Co., Ltd.
Overview
Zhejiang Huahai Pharmaceutical Co., Ltd. is a leading pharmaceutical company based in China, specializing in the research, development, and production of active pharmaceutical ingredients (APIs) and finished dosage forms. The company is dedicated to innovation in therapeutics with a strong focus on quality and compliance.
Therapeutic areas
API / Drug Master Files
Zhejiang Huahai Pharmaceutical Co., Ltd. holds 133 active (146 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- SEMAGLUTIDE INTERMEDIATE P29Active2026-03-03
- AMPHOTERICIN BActive2026-02-01
- PAROXETINE HYDROCHLORIDE HEMIHYDRATEActive2025-12-31
- ACETYLCYSTEINEActive2025-10-24
- PERINDOPRIL ARGININEActive2025-07-30
- 10-METHOXY IMINOSTILBENEActive2025-04-07
- ESCITALOPRAM OXALATEActive2025-01-25
- IBRUTINIBActive2024-11-08
- BRIVARACETAM (PROCESS II)Active2024-10-31
- VORTIOXETINE HYDROBROMIDEActive2024-09-26
- SIMVASTATINActive2024-09-03
- SACUBITRIL VALSARTAN SODIUMActive2024-07-12
- CANAGLIFLOZINActive2024-07-04
- REGORAFENIBActive2024-04-27
- MACITENTANActive2024-02-21
Showing 15 of 146 Drug Master Files.
FDA compliance signals
2 FDA enforcement records linked to this company.
- warning_letter2025-06-06
FDA Warning Letter (drug product)
- warning_letter2018-11-29
FDA Warning Letter (drug product)
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