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01 1HEXAMETHYLENE DIAMINETETRA ACID (METHYLENE PHOSPHONIC)
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2648
Submission : 1976-04-08
Status : Inactive
Type : II
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A R915 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of R915, including repackagers and relabelers. The FDA regulates R915 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. R915 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 R915 supplier is an individual or a company that provides R915 active pharmaceutical ingredient (API) or R915 finished formulations upon request. The R915 suppliers may include R915 API manufacturers, exporters, distributors and traders.
click here to find a list of R915 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A R915 DMF (Drug Master File) is a document detailing the whole manufacturing process of R915 active pharmaceutical ingredient (API) in detail. Different forms of R915 DMFs exist exist since differing nations have different regulations, such as R915 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A R915 DMF submitted to regulatory agencies in the US is known as a USDMF. R915 USDMF includes data on R915's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The R915 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of R915 suppliers with USDMF on PharmaCompass.
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