01 1Tomita Pharmaceutical
01 1U.S.P. MAGNESIUM GLUCONATE
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25269
Submission : 2011-05-10
Status : Inactive
Type : II
A U.S.P. Magnesium Gluconate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of U.S.P. Magnesium Gluconate, including repackagers and relabelers. The FDA regulates U.S.P. Magnesium Gluconate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. U.S.P. Magnesium Gluconate 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 U.S.P. Magnesium Gluconate supplier is an individual or a company that provides U.S.P. Magnesium Gluconate active pharmaceutical ingredient (API) or U.S.P. Magnesium Gluconate finished formulations upon request. The U.S.P. Magnesium Gluconate suppliers may include U.S.P. Magnesium Gluconate API manufacturers, exporters, distributors and traders.
click here to find a list of U.S.P. Magnesium Gluconate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A U.S.P. Magnesium Gluconate DMF (Drug Master File) is a document detailing the whole manufacturing process of U.S.P. Magnesium Gluconate active pharmaceutical ingredient (API) in detail. Different forms of U.S.P. Magnesium Gluconate DMFs exist exist since differing nations have different regulations, such as U.S.P. Magnesium Gluconate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A U.S.P. Magnesium Gluconate DMF submitted to regulatory agencies in the US is known as a USDMF. U.S.P. Magnesium Gluconate USDMF includes data on U.S.P. Magnesium Gluconate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The U.S.P. Magnesium Gluconate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of U.S.P. Magnesium Gluconate suppliers with USDMF on PharmaCompass.
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