01 1Glenmark Life Sciences
02 1Maithri Drugs
01 1LOMITAPIDE MESYLATE
02 1LOMITAPIDE MESYLATE (FORM-M)
01 2India
01 2Active
01 1Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-08
Pay. Date : 2016-03-23
DMF Number : 30272
Submission : 2016-03-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31454
Submission : 2017-02-22
Status : Active
Type : II
A Lomitapide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lomitapide, including repackagers and relabelers. The FDA regulates Lomitapide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lomitapide 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 Lomitapide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lomitapide supplier is an individual or a company that provides Lomitapide active pharmaceutical ingredient (API) or Lomitapide finished formulations upon request. The Lomitapide suppliers may include Lomitapide API manufacturers, exporters, distributors and traders.
click here to find a list of Lomitapide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lomitapide DMF (Drug Master File) is a document detailing the whole manufacturing process of Lomitapide active pharmaceutical ingredient (API) in detail. Different forms of Lomitapide DMFs exist exist since differing nations have different regulations, such as Lomitapide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lomitapide DMF submitted to regulatory agencies in the US is known as a USDMF. Lomitapide USDMF includes data on Lomitapide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lomitapide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lomitapide suppliers with USDMF on PharmaCompass.
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