01 1Maithri Drugs
01 1LUMACAFTOR
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33887
Submission : 2019-06-12
Status : Active
Type : II
A Lumacaftor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lumacaftor, including repackagers and relabelers. The FDA regulates Lumacaftor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lumacaftor 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 Lumacaftor manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lumacaftor supplier is an individual or a company that provides Lumacaftor active pharmaceutical ingredient (API) or Lumacaftor finished formulations upon request. The Lumacaftor suppliers may include Lumacaftor API manufacturers, exporters, distributors and traders.
click here to find a list of Lumacaftor suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lumacaftor DMF (Drug Master File) is a document detailing the whole manufacturing process of Lumacaftor active pharmaceutical ingredient (API) in detail. Different forms of Lumacaftor DMFs exist exist since differing nations have different regulations, such as Lumacaftor USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lumacaftor DMF submitted to regulatory agencies in the US is known as a USDMF. Lumacaftor USDMF includes data on Lumacaftor's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lumacaftor USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lumacaftor suppliers with USDMF on PharmaCompass.
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