01 1Jubilant DraxImage Inc
01 1STANNOUS GLUCONATE COMPLEX
01 1Canada
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18629
Submission : 1990-05-01
Status : Inactive
Type : II
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A Stannous Gluconate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Stannous Gluconate, including repackagers and relabelers. The FDA regulates Stannous Gluconate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Stannous 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 Stannous Gluconate supplier is an individual or a company that provides Stannous Gluconate active pharmaceutical ingredient (API) or Stannous Gluconate finished formulations upon request. The Stannous Gluconate suppliers may include Stannous Gluconate API manufacturers, exporters, distributors and traders.
click here to find a list of Stannous Gluconate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Stannous Gluconate DMF (Drug Master File) is a document detailing the whole manufacturing process of Stannous Gluconate active pharmaceutical ingredient (API) in detail. Different forms of Stannous Gluconate DMFs exist exist since differing nations have different regulations, such as Stannous Gluconate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Stannous Gluconate DMF submitted to regulatory agencies in the US is known as a USDMF. Stannous Gluconate USDMF includes data on Stannous Gluconate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Stannous Gluconate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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