01 1Mitsubishi Tanabe Pharma
02 1SNJ Labs
01 1A – HYDROXYANALOGUE TO METHIONINE CALCIUM SALT
02 1DL - METHIONINE
01 1India
02 1Japan
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1832
Submission : 1971-12-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38245
Submission : 2023-04-03
Status : Active
Type : II
A Methionine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methionine, including repackagers and relabelers. The FDA regulates Methionine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methionine 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 Methionine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Methionine supplier is an individual or a company that provides Methionine active pharmaceutical ingredient (API) or Methionine finished formulations upon request. The Methionine suppliers may include Methionine API manufacturers, exporters, distributors and traders.
click here to find a list of Methionine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Methionine DMF (Drug Master File) is a document detailing the whole manufacturing process of Methionine active pharmaceutical ingredient (API) in detail. Different forms of Methionine DMFs exist exist since differing nations have different regulations, such as Methionine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methionine DMF submitted to regulatory agencies in the US is known as a USDMF. Methionine USDMF includes data on Methionine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methionine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Methionine suppliers with USDMF on PharmaCompass.
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