01 1Alivus 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
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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 Mesylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lomitapide Mesylate, including repackagers and relabelers. The FDA regulates Lomitapide Mesylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lomitapide Mesylate 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 Mesylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lomitapide Mesylate supplier is an individual or a company that provides Lomitapide Mesylate active pharmaceutical ingredient (API) or Lomitapide Mesylate finished formulations upon request. The Lomitapide Mesylate suppliers may include Lomitapide Mesylate API manufacturers, exporters, distributors and traders.
click here to find a list of Lomitapide Mesylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lomitapide Mesylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Lomitapide Mesylate active pharmaceutical ingredient (API) in detail. Different forms of Lomitapide Mesylate DMFs exist exist since differing nations have different regulations, such as Lomitapide Mesylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lomitapide Mesylate DMF submitted to regulatory agencies in the US is known as a USDMF. Lomitapide Mesylate USDMF includes data on Lomitapide Mesylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lomitapide Mesylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lomitapide Mesylate suppliers with USDMF on PharmaCompass.
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