Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Cohance Lifesciences
03 1Medichem S.A
04 1Alembic Pharmaceuticals Limited
05 1Alkaloida Chemical Company Zrt
06 1Hetero Drugs
07 1Kalintis Healthcare
08 2Macleods Pharmaceuticals Limited
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2020-09-01
Pay. Date : 2020-08-06
DMF Number : 34668
Submission : 2020-03-06
Status :
Type : II
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2021-05-12
Pay. Date : 2021-03-24
DMF Number : 34958
Submission : 2020-06-19
Status :
Type : II
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-21
Pay. Date : 2019-05-23
DMF Number : 9257
Submission : 1991-07-26
Status :
Type : II
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PharmaCompass offers a list of Mexiletine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Mexiletine manufacturer or Mexiletine supplier for your needs.
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A Mexiletine, HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mexiletine, HCl, including repackagers and relabelers. The FDA regulates Mexiletine, HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mexiletine, HCl API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Mexiletine, HCl supplier is an individual or a company that provides Mexiletine, HCl active pharmaceutical ingredient (API) or Mexiletine, HCl finished formulations upon request. The Mexiletine, HCl suppliers may include Mexiletine, HCl API manufacturers, exporters, distributors and traders.
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A Mexiletine, HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Mexiletine, HCl active pharmaceutical ingredient (API) in detail. Different forms of Mexiletine, HCl DMFs exist exist since differing nations have different regulations, such as Mexiletine, HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mexiletine, HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Mexiletine, HCl USDMF includes data on Mexiletine, HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mexiletine, HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
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We have 8 companies offering Mexiletine, HCl
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