Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Emcure Pharmaceuticals
03 1Erregierre SpA
04 1MSN Laboratories
05 1Optimus Pharma
06 1Solara Active Pharma Sciences
07 1Viatris
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-16
Pay. Date : 2014-06-05
DMF Number : 26446
Submission : 2012-09-26
Status :
Type : II
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PharmaCompass offers a list of Zileuton API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Zileuton manufacturer or Zileuton supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Zileuton manufacturer or Zileuton supplier.
A Ziluton manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ziluton, including repackagers and relabelers. The FDA regulates Ziluton manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ziluton 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 Ziluton manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ziluton supplier is an individual or a company that provides Ziluton active pharmaceutical ingredient (API) or Ziluton finished formulations upon request. The Ziluton suppliers may include Ziluton API manufacturers, exporters, distributors and traders.
click here to find a list of Ziluton suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Ziluton DMF (Drug Master File) is a document detailing the whole manufacturing process of Ziluton active pharmaceutical ingredient (API) in detail. Different forms of Ziluton DMFs exist exist since differing nations have different regulations, such as Ziluton USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ziluton DMF submitted to regulatory agencies in the US is known as a USDMF. Ziluton USDMF includes data on Ziluton's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ziluton USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ziluton suppliers with USDMF on PharmaCompass.
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