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