Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Seqens
03 1Dr. Reddy's Laboratories
04 1FMCCorporation - ICG
05 1Srikem Laboratories Pvt. Ltd
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2016-03-25
Pay. Date : 2016-02-22
DMF Number : 30243
Submission : 2016-02-13
Status :
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-16
Pay. Date : 2016-12-07
DMF Number : 31190
Submission : 2016-12-29
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2016-03-03
Pay. Date : 2015-07-09
DMF Number : 11702
Submission : 1995-10-10
Status :
Type : II
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PharmaCompass offers a list of Permethrin 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 Permethrin manufacturer or Permethrin supplier for your needs.
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A NIX manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of NIX, including repackagers and relabelers. The FDA regulates NIX manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. NIX 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 NIX supplier is an individual or a company that provides NIX active pharmaceutical ingredient (API) or NIX finished formulations upon request. The NIX suppliers may include NIX API manufacturers, exporters, distributors and traders.
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A NIX DMF (Drug Master File) is a document detailing the whole manufacturing process of NIX active pharmaceutical ingredient (API) in detail. Different forms of NIX DMFs exist exist since differing nations have different regulations, such as NIX USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A NIX DMF submitted to regulatory agencies in the US is known as a USDMF. NIX USDMF includes data on NIX's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The NIX USDMF is kept confidential to protect the manufacturer’s intellectual property.
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