Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Granules India Limited
03 2Changzhou Pharmaceutical Factory
04 2Chongqing Huapont Pharmaceutical
05 1Cipla
06 1Intas Pharmaceuticals
07 4MSN Laboratories
08 2Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41012
Submission : 2024-12-31
Status :
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Complete
Rev. Date : 2025-03-14
Pay. Date : 2025-03-06
DMF Number : 40874
Submission : 2025-02-12
Status :
Type : II
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A Jakafi manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Jakafi, including repackagers and relabelers. The FDA regulates Jakafi manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Jakafi 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 Jakafi supplier is an individual or a company that provides Jakafi active pharmaceutical ingredient (API) or Jakafi finished formulations upon request. The Jakafi suppliers may include Jakafi API manufacturers, exporters, distributors and traders.
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A Jakafi DMF (Drug Master File) is a document detailing the whole manufacturing process of Jakafi active pharmaceutical ingredient (API) in detail. Different forms of Jakafi DMFs exist exist since differing nations have different regulations, such as Jakafi USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Jakafi DMF submitted to regulatory agencies in the US is known as a USDMF. Jakafi USDMF includes data on Jakafi's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Jakafi USDMF is kept confidential to protect the manufacturer’s intellectual property.
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