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