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, Price,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.
PharmaCompass also assists you with knowing the Zileuton API Price utilized in the formulation of products. Zileuton API Price is not always fixed or binding as the Zileuton Price is obtained through a variety of data sources. The Zileuton Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Zileuton manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zileuton, including repackagers and relabelers. The FDA regulates Zileuton manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zileuton 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 Zileuton manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zileuton supplier is an individual or a company that provides Zileuton active pharmaceutical ingredient (API) or Zileuton finished formulations upon request. The Zileuton suppliers may include Zileuton API manufacturers, exporters, distributors and traders.
click here to find a list of Zileuton suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zileuton DMF (Drug Master File) is a document detailing the whole manufacturing process of Zileuton active pharmaceutical ingredient (API) in detail. Different forms of Zileuton DMFs exist exist since differing nations have different regulations, such as Zileuton USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zileuton DMF submitted to regulatory agencies in the US is known as a USDMF. Zileuton USDMF includes data on Zileuton's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zileuton USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zileuton suppliers with USDMF on PharmaCompass.
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