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
A (+)-Mexiletine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (+)-Mexiletine Hydrochloride, including repackagers and relabelers. The FDA regulates (+)-Mexiletine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (+)-Mexiletine Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A (+)-Mexiletine Hydrochloride supplier is an individual or a company that provides (+)-Mexiletine Hydrochloride active pharmaceutical ingredient (API) or (+)-Mexiletine Hydrochloride finished formulations upon request. The (+)-Mexiletine Hydrochloride suppliers may include (+)-Mexiletine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of (+)-Mexiletine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A (+)-Mexiletine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of (+)-Mexiletine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of (+)-Mexiletine Hydrochloride DMFs exist exist since differing nations have different regulations, such as (+)-Mexiletine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (+)-Mexiletine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. (+)-Mexiletine Hydrochloride USDMF includes data on (+)-Mexiletine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (+)-Mexiletine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of (+)-Mexiletine Hydrochloride suppliers with USDMF on PharmaCompass.
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