Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Agno Pharma
03 1Aurobindo Pharma Limited
04 1Dishman Carbogen Amcis
05 1Emcure Pharmaceuticals
06 1MSN Laboratories
07 1SAFC
08 1Suven Pharmaceuticals
09 1Viatris
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2016-01-08
Pay. Date : 2015-09-29
DMF Number : 29829
Submission : 2015-09-29
Status :
Type : II
A Iso-Sulfan Blue manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iso-Sulfan Blue, including repackagers and relabelers. The FDA regulates Iso-Sulfan Blue manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iso-Sulfan Blue 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 Iso-Sulfan Blue manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Iso-Sulfan Blue supplier is an individual or a company that provides Iso-Sulfan Blue active pharmaceutical ingredient (API) or Iso-Sulfan Blue finished formulations upon request. The Iso-Sulfan Blue suppliers may include Iso-Sulfan Blue API manufacturers, exporters, distributors and traders.
click here to find a list of Iso-Sulfan Blue suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Iso-Sulfan Blue DMF (Drug Master File) is a document detailing the whole manufacturing process of Iso-Sulfan Blue active pharmaceutical ingredient (API) in detail. Different forms of Iso-Sulfan Blue DMFs exist exist since differing nations have different regulations, such as Iso-Sulfan Blue USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Iso-Sulfan Blue DMF submitted to regulatory agencies in the US is known as a USDMF. Iso-Sulfan Blue USDMF includes data on Iso-Sulfan Blue's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Iso-Sulfan Blue USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Iso-Sulfan Blue suppliers with USDMF on PharmaCompass.
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