Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Kekule Pharma
01 2NILUTAMIDE
01 2India
01 2Active
01 2Complete
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-12
Pay. Date : 2014-12-24
DMF Number : 28262
Submission : 2014-06-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-11-18
Pay. Date : 2014-06-17
DMF Number : 25465
Submission : 2011-09-29
Status : Active
Type : II
A Nilutamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nilutamide, including repackagers and relabelers. The FDA regulates Nilutamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nilutamide 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 Nilutamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nilutamide supplier is an individual or a company that provides Nilutamide active pharmaceutical ingredient (API) or Nilutamide finished formulations upon request. The Nilutamide suppliers may include Nilutamide API manufacturers, exporters, distributors and traders.
click here to find a list of Nilutamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nilutamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Nilutamide active pharmaceutical ingredient (API) in detail. Different forms of Nilutamide DMFs exist exist since differing nations have different regulations, such as Nilutamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nilutamide DMF submitted to regulatory agencies in the US is known as a USDMF. Nilutamide USDMF includes data on Nilutamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nilutamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nilutamide suppliers with USDMF on PharmaCompass.
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