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