01 1Aurobindo Pharma Limited
02 1MSN Laboratories
03 1Blank
01 3ENCORAFENIB
01 2India
02 1Blank
01 3Active
01 2Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2022-01-04
Pay. Date : 2021-12-20
DMF Number : 36630
Submission : 2021-12-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-04-06
Pay. Date : 2022-01-07
DMF Number : 35756
Submission : 2021-03-31
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41902
Submission : 2025-06-13
Status : Active
Type : II
Portfolio PDF
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PharmaCompass offers a list of Encorafenib 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 Encorafenib manufacturer or Encorafenib supplier for your needs.
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A NVP-LGX818-NXA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of NVP-LGX818-NXA, including repackagers and relabelers. The FDA regulates NVP-LGX818-NXA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. NVP-LGX818-NXA API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A NVP-LGX818-NXA DMF (Drug Master File) is a document detailing the whole manufacturing process of NVP-LGX818-NXA active pharmaceutical ingredient (API) in detail. Different forms of NVP-LGX818-NXA DMFs exist exist since differing nations have different regulations, such as NVP-LGX818-NXA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A NVP-LGX818-NXA DMF submitted to regulatory agencies in the US is known as a USDMF. NVP-LGX818-NXA USDMF includes data on NVP-LGX818-NXA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The NVP-LGX818-NXA USDMF is kept confidential to protect the manufacturer’s intellectual property.
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