01 1SIGMA TAU
01 1D-GLUCONIC ACID HEMI CALCIUM SALT
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4736
Submission : 1982-11-19
Status : Inactive
Type : II
A D-Gluconic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of D-Gluconic Acid, including repackagers and relabelers. The FDA regulates D-Gluconic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. D-Gluconic 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 D-Gluconic Acid supplier is an individual or a company that provides D-Gluconic Acid active pharmaceutical ingredient (API) or D-Gluconic Acid finished formulations upon request. The D-Gluconic Acid suppliers may include D-Gluconic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of D-Gluconic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A D-Gluconic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of D-Gluconic Acid active pharmaceutical ingredient (API) in detail. Different forms of D-Gluconic Acid DMFs exist exist since differing nations have different regulations, such as D-Gluconic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A D-Gluconic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. D-Gluconic Acid USDMF includes data on D-Gluconic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The D-Gluconic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of D-Gluconic Acid suppliers with USDMF on PharmaCompass.
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