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
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PharmaCompass offers a list of 4-Phenyl Butyric Acid API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right 4-Phenyl Butyric Acid manufacturer or 4-Phenyl Butyric Acid supplier for your needs.
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A Phenylbutyrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phenylbutyrate, including repackagers and relabelers. The FDA regulates Phenylbutyrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phenylbutyrate 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 Phenylbutyrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Phenylbutyrate supplier is an individual or a company that provides Phenylbutyrate active pharmaceutical ingredient (API) or Phenylbutyrate finished formulations upon request. The Phenylbutyrate suppliers may include Phenylbutyrate API manufacturers, exporters, distributors and traders.
click here to find a list of Phenylbutyrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Phenylbutyrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Phenylbutyrate active pharmaceutical ingredient (API) in detail. Different forms of Phenylbutyrate DMFs exist exist since differing nations have different regulations, such as Phenylbutyrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Phenylbutyrate DMF submitted to regulatory agencies in the US is known as a USDMF. Phenylbutyrate USDMF includes data on Phenylbutyrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Phenylbutyrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Phenylbutyrate suppliers with USDMF on PharmaCompass.
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