Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
01 1Cohance Lifesciences
02 1Medichem S.A
03 1Arevipharma
04 1Aurore Life Sciences
05 1Cambrex Corporation
06 1Global Calcium
07 1Mankind Pharma
08 1R L Fine Chem
09 1SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL
10 1Sandoz B2B
11 1Shouguang Fukang Pharmaceutical Co., Ltd
12 1Viatris
13 1Wuhan Shiji Pharmaceutical
14 2Blank
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2019-01-29
Pay. Date : 2018-12-07
DMF Number : 31999
Submission : 2017-08-24
Status :
Type : II
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-29
Pay. Date : 2015-01-26
DMF Number : 10534
Submission : 1993-10-21
Status :
Type : II
A Clozapine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clozapine, including repackagers and relabelers. The FDA regulates Clozapine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clozapine 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 Clozapine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Clozapine supplier is an individual or a company that provides Clozapine active pharmaceutical ingredient (API) or Clozapine finished formulations upon request. The Clozapine suppliers may include Clozapine API manufacturers, exporters, distributors and traders.
click here to find a list of Clozapine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Clozapine DMF (Drug Master File) is a document detailing the whole manufacturing process of Clozapine active pharmaceutical ingredient (API) in detail. Different forms of Clozapine DMFs exist exist since differing nations have different regulations, such as Clozapine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Clozapine DMF submitted to regulatory agencies in the US is known as a USDMF. Clozapine USDMF includes data on Clozapine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Clozapine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Clozapine suppliers with USDMF on PharmaCompass.
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