01 1Archimica
01 1BROMFENAC SODIUM
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-31
Pay. Date : 2013-07-18
DMF Number : 23704
Submission : 2010-04-12
Status : Active
Type : II
A Bromfenac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bromfenac, including repackagers and relabelers. The FDA regulates Bromfenac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bromfenac 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 Bromfenac manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bromfenac supplier is an individual or a company that provides Bromfenac active pharmaceutical ingredient (API) or Bromfenac finished formulations upon request. The Bromfenac suppliers may include Bromfenac API manufacturers, exporters, distributors and traders.
click here to find a list of Bromfenac suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bromfenac DMF (Drug Master File) is a document detailing the whole manufacturing process of Bromfenac active pharmaceutical ingredient (API) in detail. Different forms of Bromfenac DMFs exist exist since differing nations have different regulations, such as Bromfenac USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bromfenac DMF submitted to regulatory agencies in the US is known as a USDMF. Bromfenac USDMF includes data on Bromfenac's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bromfenac USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bromfenac suppliers with USDMF on PharmaCompass.
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