Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Nuray Chemicals Private Limited
03 1Cohance Lifesciences
04 1Actavis Inc
05 2Lupin Ltd
06 1Panion and Bf Biotech
07 1West Bengal Chemicals Industries
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-27
Pay. Date : 2016-09-28
DMF Number : 30835
Submission : 2016-09-28
Status :
Type : II
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-01
Pay. Date : 2014-04-10
DMF Number : 28175
Submission : 2014-05-15
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 : 2019-05-29
Pay. Date : 2019-05-14
DMF Number : 33674
Submission : 2019-03-13
Status :
Type : II
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PharmaCompass offers a list of Ferric Citrate 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 Ferric Citrate manufacturer or Ferric Citrate supplier for your needs.
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A AURYXIA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AURYXIA, including repackagers and relabelers. The FDA regulates AURYXIA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AURYXIA 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 AURYXIA supplier is an individual or a company that provides AURYXIA active pharmaceutical ingredient (API) or AURYXIA finished formulations upon request. The AURYXIA suppliers may include AURYXIA API manufacturers, exporters, distributors and traders.
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A AURYXIA DMF (Drug Master File) is a document detailing the whole manufacturing process of AURYXIA active pharmaceutical ingredient (API) in detail. Different forms of AURYXIA DMFs exist exist since differing nations have different regulations, such as AURYXIA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A AURYXIA DMF submitted to regulatory agencies in the US is known as a USDMF. AURYXIA USDMF includes data on AURYXIA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AURYXIA USDMF is kept confidential to protect the manufacturer’s intellectual property.
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