01 1Shanghai Hegeng Industrial Co. Ltd
01 1D-GLUCURONIC ACID
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33702
Submission : 2019-03-22
Status : Active
Type : IV
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A Glucuronic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glucuronic Acid, including repackagers and relabelers. The FDA regulates Glucuronic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glucuronic 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.
A Glucuronic Acid supplier is an individual or a company that provides Glucuronic Acid active pharmaceutical ingredient (API) or Glucuronic Acid finished formulations upon request. The Glucuronic Acid suppliers may include Glucuronic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Glucuronic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Glucuronic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Glucuronic Acid active pharmaceutical ingredient (API) in detail. Different forms of Glucuronic Acid DMFs exist exist since differing nations have different regulations, such as Glucuronic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glucuronic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Glucuronic Acid USDMF includes data on Glucuronic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glucuronic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
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