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01 1BAMIFYLLINE (TRENTADIL)
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4894
Submission : 1982-12-20
Status : Inactive
Type : II
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A Bamifylline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bamifylline, including repackagers and relabelers. The FDA regulates Bamifylline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bamifylline 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 Bamifylline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bamifylline supplier is an individual or a company that provides Bamifylline active pharmaceutical ingredient (API) or Bamifylline finished formulations upon request. The Bamifylline suppliers may include Bamifylline API manufacturers, exporters, distributors and traders.
click here to find a list of Bamifylline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bamifylline DMF (Drug Master File) is a document detailing the whole manufacturing process of Bamifylline active pharmaceutical ingredient (API) in detail. Different forms of Bamifylline DMFs exist exist since differing nations have different regulations, such as Bamifylline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bamifylline DMF submitted to regulatory agencies in the US is known as a USDMF. Bamifylline USDMF includes data on Bamifylline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bamifylline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bamifylline suppliers with USDMF on PharmaCompass.
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