Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
01 1Medichem S.A
02 1Changzhou Pharmaceutical Factory
03 1F. Hoffmann-La Roche
04 2Forest Laboratories
05 1Quimica Sintetica
06 1Servier
07 1Shandong Weifang Pharma Factory Co., Ltd
08 1Sinovac Biotech
09 1Wockhardt
10 1Zhejiang Huahai Pharmaceutical
11 2Blank
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2018-01-19
Pay. Date : 2017-12-05
DMF Number : 32247
Submission : 2017-12-04
Status :
Type : II
A Captopril manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Captopril, including repackagers and relabelers. The FDA regulates Captopril manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Captopril API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Captopril manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Captopril supplier is an individual or a company that provides Captopril active pharmaceutical ingredient (API) or Captopril finished formulations upon request. The Captopril suppliers may include Captopril API manufacturers, exporters, distributors and traders.
click here to find a list of Captopril suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Captopril DMF (Drug Master File) is a document detailing the whole manufacturing process of Captopril active pharmaceutical ingredient (API) in detail. Different forms of Captopril DMFs exist exist since differing nations have different regulations, such as Captopril USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Captopril DMF submitted to regulatory agencies in the US is known as a USDMF. Captopril USDMF includes data on Captopril's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Captopril USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Captopril suppliers with USDMF on PharmaCompass.
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