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 Alpharma brand of buflomedil hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alpharma brand of buflomedil hydrochloride, including repackagers and relabelers. The FDA regulates Alpharma brand of buflomedil hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alpharma brand of buflomedil hydrochloride 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 Alpharma brand of buflomedil hydrochloride supplier is an individual or a company that provides Alpharma brand of buflomedil hydrochloride active pharmaceutical ingredient (API) or Alpharma brand of buflomedil hydrochloride finished formulations upon request. The Alpharma brand of buflomedil hydrochloride suppliers may include Alpharma brand of buflomedil hydrochloride API manufacturers, exporters, distributors and traders.
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A Alpharma brand of buflomedil hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Alpharma brand of buflomedil hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Alpharma brand of buflomedil hydrochloride DMFs exist exist since differing nations have different regulations, such as Alpharma brand of buflomedil hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alpharma brand of buflomedil hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Alpharma brand of buflomedil hydrochloride USDMF includes data on Alpharma brand of buflomedil hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alpharma brand of buflomedil hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
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