01 1Mallinckrodt Pharmaceuticals
02 1Blank
01 1LEVO-ISO-METHADONE
02 1METHADONE BASE SPECIAL
01 1Ireland
02 1Blank
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22700
Submission : 2009-04-02
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 63
Submission : 1951-03-05
Status : Inactive
Type : II
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A Methadone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methadone, including repackagers and relabelers. The FDA regulates Methadone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methadone 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 Methadone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Methadone supplier is an individual or a company that provides Methadone active pharmaceutical ingredient (API) or Methadone finished formulations upon request. The Methadone suppliers may include Methadone API manufacturers, exporters, distributors and traders.
click here to find a list of Methadone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Methadone DMF (Drug Master File) is a document detailing the whole manufacturing process of Methadone active pharmaceutical ingredient (API) in detail. Different forms of Methadone DMFs exist exist since differing nations have different regulations, such as Methadone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methadone DMF submitted to regulatory agencies in the US is known as a USDMF. Methadone USDMF includes data on Methadone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methadone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Methadone suppliers with USDMF on PharmaCompass.
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