01 1Qilu Tianhe Pharmaceutical Co., Ltd.
01 1BUFLOMEDIL HYDROCHLORIDE (NON STERILE API)
01 1China
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22039
Submission : 2008-09-28
Status : Inactive
Type : II
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A Buflan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Buflan, including repackagers and relabelers. The FDA regulates Buflan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Buflan API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Buflan supplier is an individual or a company that provides Buflan active pharmaceutical ingredient (API) or Buflan finished formulations upon request. The Buflan suppliers may include Buflan API manufacturers, exporters, distributors and traders.
click here to find a list of Buflan suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Buflan DMF (Drug Master File) is a document detailing the whole manufacturing process of Buflan active pharmaceutical ingredient (API) in detail. Different forms of Buflan DMFs exist exist since differing nations have different regulations, such as Buflan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Buflan DMF submitted to regulatory agencies in the US is known as a USDMF. Buflan USDMF includes data on Buflan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Buflan USDMF is kept confidential to protect the manufacturer’s intellectual property.
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