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01 1Glenmark Life Sciences
02 1Maithri Drugs
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01 1LOMITAPIDE MESYLATE
02 1LOMITAPIDE MESYLATE (FORM-M)
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01 2India
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01 2Active
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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
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PharmaCompass offers a list of Lomitapide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Lomitapide manufacturer or Lomitapide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lomitapide manufacturer or Lomitapide supplier.
PharmaCompass also assists you with knowing the Lomitapide API Price utilized in the formulation of products. Lomitapide API Price is not always fixed or binding as the Lomitapide Price is obtained through a variety of data sources. The Lomitapide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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.
We have 2 companies offering Lomitapide
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