01 2Leo Pharma
01 2AMDINOCILLIN
01 2Denmark
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13662
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13639
Submission : 1998-09-01
Status : Inactive
Type : II
100
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A Mecillinam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mecillinam, including repackagers and relabelers. The FDA regulates Mecillinam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mecillinam 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 Mecillinam supplier is an individual or a company that provides Mecillinam active pharmaceutical ingredient (API) or Mecillinam finished formulations upon request. The Mecillinam suppliers may include Mecillinam API manufacturers, exporters, distributors and traders.
click here to find a list of Mecillinam suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Mecillinam DMF (Drug Master File) is a document detailing the whole manufacturing process of Mecillinam active pharmaceutical ingredient (API) in detail. Different forms of Mecillinam DMFs exist exist since differing nations have different regulations, such as Mecillinam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mecillinam DMF submitted to regulatory agencies in the US is known as a USDMF. Mecillinam USDMF includes data on Mecillinam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mecillinam USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mecillinam suppliers with USDMF on PharmaCompass.
