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.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mexiletine manufacturer or Mexiletine supplier.
PharmaCompass also assists you with knowing the Mexiletine API Price utilized in the formulation of products. Mexiletine API Price is not always fixed or binding as the Mexiletine Price is obtained through a variety of data sources. The Mexiletine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Mexiletine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mexiletine, including repackagers and relabelers. The FDA regulates Mexiletine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mexiletine 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 Mexiletine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mexiletine supplier is an individual or a company that provides Mexiletine active pharmaceutical ingredient (API) or Mexiletine finished formulations upon request. The Mexiletine suppliers may include Mexiletine API manufacturers, exporters, distributors and traders.
click here to find a list of Mexiletine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mexiletine DMF (Drug Master File) is a document detailing the whole manufacturing process of Mexiletine active pharmaceutical ingredient (API) in detail. Different forms of Mexiletine DMFs exist exist since differing nations have different regulations, such as Mexiletine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mexiletine DMF submitted to regulatory agencies in the US is known as a USDMF. Mexiletine USDMF includes data on Mexiletine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mexiletine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mexiletine suppliers with USDMF on PharmaCompass.
We have 8 companies offering Mexiletine
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