01 1Royal DSM
01 1DEXPANTHENOL
01 1Netherlands
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-08-01
Pay. Date : 2017-01-09
DMF Number : 30723
Submission : 2016-09-02
Status : Active
Type : II
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A M365 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of M365, including repackagers and relabelers. The FDA regulates M365 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. M365 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 M365 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A M365 supplier is an individual or a company that provides M365 active pharmaceutical ingredient (API) or M365 finished formulations upon request. The M365 suppliers may include M365 API manufacturers, exporters, distributors and traders.
click here to find a list of M365 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A M365 DMF (Drug Master File) is a document detailing the whole manufacturing process of M365 active pharmaceutical ingredient (API) in detail. Different forms of M365 DMFs exist exist since differing nations have different regulations, such as M365 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A M365 DMF submitted to regulatory agencies in the US is known as a USDMF. M365 USDMF includes data on M365's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The M365 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of M365 suppliers with USDMF on PharmaCompass.
