01 2SAFC
01 1METHACETIN-METHOXY-13C
02 1METHACETIN-METHOXY-13C, MBT GRADE
01 2U.S.A
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21665
Submission : 2008-05-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20303
Submission : 2007-02-23
Status : Inactive
Type : II
A Methacetin-13C manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methacetin-13C, including repackagers and relabelers. The FDA regulates Methacetin-13C manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methacetin-13C 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 Methacetin-13C manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Methacetin-13C supplier is an individual or a company that provides Methacetin-13C active pharmaceutical ingredient (API) or Methacetin-13C finished formulations upon request. The Methacetin-13C suppliers may include Methacetin-13C API manufacturers, exporters, distributors and traders.
click here to find a list of Methacetin-13C suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Methacetin-13C DMF (Drug Master File) is a document detailing the whole manufacturing process of Methacetin-13C active pharmaceutical ingredient (API) in detail. Different forms of Methacetin-13C DMFs exist exist since differing nations have different regulations, such as Methacetin-13C USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methacetin-13C DMF submitted to regulatory agencies in the US is known as a USDMF. Methacetin-13C USDMF includes data on Methacetin-13C's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methacetin-13C USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Methacetin-13C suppliers with USDMF on PharmaCompass.
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