01 1ALP Pharm
01 1D-METHIONINE
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25859
Submission : 2012-03-15
Status : Active
Type : II
A D-Methionine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of D-Methionine, including repackagers and relabelers. The FDA regulates D-Methionine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. D-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.
A D-Methionine supplier is an individual or a company that provides D-Methionine active pharmaceutical ingredient (API) or D-Methionine finished formulations upon request. The D-Methionine suppliers may include D-Methionine API manufacturers, exporters, distributors and traders.
click here to find a list of D-Methionine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A D-Methionine DMF (Drug Master File) is a document detailing the whole manufacturing process of D-Methionine active pharmaceutical ingredient (API) in detail. Different forms of D-Methionine DMFs exist exist since differing nations have different regulations, such as D-Methionine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A D-Methionine DMF submitted to regulatory agencies in the US is known as a USDMF. D-Methionine USDMF includes data on D-Methionine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The D-Methionine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of D-Methionine suppliers with USDMF on PharmaCompass.
We have 1 companies offering D-Methionine
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?