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01 1Evonik
02 1AMINO GmbH
03 1SIGMA TAU
04 1Sekisui Medical Co. Ltd
05 1Sigma-Aldrich Corporation
06 2Blank
01 6L-METHIONINE
02 1SELENO-DL-METHIONINE AS SUPPLIED BY SIGMA (ISRAEL)CHEMICAL COMPANY
01 2Germany
02 1Japan
03 2U.S.A
04 2Blank
01 3Active
02 4Inactive
01 1Complete
02 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18726
Submission : 2005-08-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39084
Submission : 2023-11-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-23
Pay. Date : 2021-01-12
DMF Number : 4953
Submission : 1983-05-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4860
Submission : 1983-04-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9989
Submission : 1992-11-25
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7342
Submission : 1988-02-17
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1249
Submission : 1968-10-25
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A L-Methionine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Methionine, including repackagers and relabelers. The FDA regulates L-Methionine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-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 L-Methionine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Methionine supplier is an individual or a company that provides L-Methionine active pharmaceutical ingredient (API) or L-Methionine finished formulations upon request. The L-Methionine suppliers may include L-Methionine API manufacturers, exporters, distributors and traders.
click here to find a list of L-Methionine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Methionine DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Methionine active pharmaceutical ingredient (API) in detail. Different forms of L-Methionine DMFs exist exist since differing nations have different regulations, such as L-Methionine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-Methionine DMF submitted to regulatory agencies in the US is known as a USDMF. L-Methionine USDMF includes data on L-Methionine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Methionine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-Methionine suppliers with USDMF on PharmaCompass.
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