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01 1ALGLUTAMOL
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3248
Submission : 1978-04-11
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
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Digital Content
Website
Corporate PDF
A UNII-I670EI8M2N manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of UNII-I670EI8M2N, including repackagers and relabelers. The FDA regulates UNII-I670EI8M2N manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. UNII-I670EI8M2N 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 UNII-I670EI8M2N supplier is an individual or a company that provides UNII-I670EI8M2N active pharmaceutical ingredient (API) or UNII-I670EI8M2N finished formulations upon request. The UNII-I670EI8M2N suppliers may include UNII-I670EI8M2N API manufacturers, exporters, distributors and traders.
click here to find a list of UNII-I670EI8M2N suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A UNII-I670EI8M2N DMF (Drug Master File) is a document detailing the whole manufacturing process of UNII-I670EI8M2N active pharmaceutical ingredient (API) in detail. Different forms of UNII-I670EI8M2N DMFs exist exist since differing nations have different regulations, such as UNII-I670EI8M2N USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A UNII-I670EI8M2N DMF submitted to regulatory agencies in the US is known as a USDMF. UNII-I670EI8M2N USDMF includes data on UNII-I670EI8M2N's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The UNII-I670EI8M2N USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of UNII-I670EI8M2N suppliers with USDMF on PharmaCompass.
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