01 1Jiangxi Synergy Pharmaceutical
01 1ACECLOFENAC
01 1China
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24210
Submission : 2010-09-24
Status : Inactive
Type : II
A Biofenac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Biofenac, including repackagers and relabelers. The FDA regulates Biofenac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Biofenac 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 Biofenac manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Biofenac supplier is an individual or a company that provides Biofenac active pharmaceutical ingredient (API) or Biofenac finished formulations upon request. The Biofenac suppliers may include Biofenac API manufacturers, exporters, distributors and traders.
click here to find a list of Biofenac suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Biofenac DMF (Drug Master File) is a document detailing the whole manufacturing process of Biofenac active pharmaceutical ingredient (API) in detail. Different forms of Biofenac DMFs exist exist since differing nations have different regulations, such as Biofenac USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Biofenac DMF submitted to regulatory agencies in the US is known as a USDMF. Biofenac USDMF includes data on Biofenac's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Biofenac USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Biofenac suppliers with USDMF on PharmaCompass.
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