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 1Cipla
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-28
Pay. Date : 2013-09-25
DMF Number : 27470
Submission : 2013-09-23
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 : 2013-10-19
Pay. Date : 2013-09-12
DMF Number : 27378
Submission : 2013-09-16
Status :
Type : II
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PharmaCompass offers a list of Alosetron Hydrochloride 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 Alosetron Hydrochloride manufacturer or Alosetron Hydrochloride supplier for your needs.
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A Lotronex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lotronex, including repackagers and relabelers. The FDA regulates Lotronex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lotronex 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 Lotronex supplier is an individual or a company that provides Lotronex active pharmaceutical ingredient (API) or Lotronex finished formulations upon request. The Lotronex suppliers may include Lotronex API manufacturers, exporters, distributors and traders.
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A Lotronex DMF (Drug Master File) is a document detailing the whole manufacturing process of Lotronex active pharmaceutical ingredient (API) in detail. Different forms of Lotronex DMFs exist exist since differing nations have different regulations, such as Lotronex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lotronex DMF submitted to regulatory agencies in the US is known as a USDMF. Lotronex USDMF includes data on Lotronex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lotronex USDMF is kept confidential to protect the manufacturer’s intellectual property.
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