01 1Taiho Pharmaceutical
01 1CDHP
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12554
Submission : 1997-06-18
Status : Inactive
Type : II
A 5-CHLORO-4-HYDROXY-2-PYRIDONE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 5-CHLORO-4-HYDROXY-2-PYRIDONE, including repackagers and relabelers. The FDA regulates 5-CHLORO-4-HYDROXY-2-PYRIDONE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 5-CHLORO-4-HYDROXY-2-PYRIDONE 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 5-CHLORO-4-HYDROXY-2-PYRIDONE supplier is an individual or a company that provides 5-CHLORO-4-HYDROXY-2-PYRIDONE active pharmaceutical ingredient (API) or 5-CHLORO-4-HYDROXY-2-PYRIDONE finished formulations upon request. The 5-CHLORO-4-HYDROXY-2-PYRIDONE suppliers may include 5-CHLORO-4-HYDROXY-2-PYRIDONE API manufacturers, exporters, distributors and traders.
click here to find a list of 5-CHLORO-4-HYDROXY-2-PYRIDONE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 5-CHLORO-4-HYDROXY-2-PYRIDONE DMF (Drug Master File) is a document detailing the whole manufacturing process of 5-CHLORO-4-HYDROXY-2-PYRIDONE active pharmaceutical ingredient (API) in detail. Different forms of 5-CHLORO-4-HYDROXY-2-PYRIDONE DMFs exist exist since differing nations have different regulations, such as 5-CHLORO-4-HYDROXY-2-PYRIDONE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 5-CHLORO-4-HYDROXY-2-PYRIDONE DMF submitted to regulatory agencies in the US is known as a USDMF. 5-CHLORO-4-HYDROXY-2-PYRIDONE USDMF includes data on 5-CHLORO-4-HYDROXY-2-PYRIDONE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 5-CHLORO-4-HYDROXY-2-PYRIDONE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 5-CHLORO-4-HYDROXY-2-PYRIDONE suppliers with USDMF on PharmaCompass.
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