01 1Cheng Fong Chemical Co., Ltd
01 14-PHENYLBUTYRIC ACID SODIUM SALT
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-28
Pay. Date : 2013-07-18
DMF Number : 25726
Submission : 2012-01-25
Status : Active
Type : II
A 4-Phenyl-butyric acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 4-Phenyl-butyric acid, including repackagers and relabelers. The FDA regulates 4-Phenyl-butyric acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 4-Phenyl-butyric acid 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 4-Phenyl-butyric acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 4-Phenyl-butyric acid supplier is an individual or a company that provides 4-Phenyl-butyric acid active pharmaceutical ingredient (API) or 4-Phenyl-butyric acid finished formulations upon request. The 4-Phenyl-butyric acid suppliers may include 4-Phenyl-butyric acid API manufacturers, exporters, distributors and traders.
click here to find a list of 4-Phenyl-butyric acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 4-Phenyl-butyric acid DMF (Drug Master File) is a document detailing the whole manufacturing process of 4-Phenyl-butyric acid active pharmaceutical ingredient (API) in detail. Different forms of 4-Phenyl-butyric acid DMFs exist exist since differing nations have different regulations, such as 4-Phenyl-butyric acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 4-Phenyl-butyric acid DMF submitted to regulatory agencies in the US is known as a USDMF. 4-Phenyl-butyric acid USDMF includes data on 4-Phenyl-butyric acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 4-Phenyl-butyric acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 4-Phenyl-butyric acid suppliers with USDMF on PharmaCompass.
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