01 1Alembic Pharmaceuticals Limited
02 1MSN Laboratories
03 1Blank
01 3BINIMETINIB
01 2India
02 1Blank
01 3Active
01 2Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-13
Pay. Date : 2022-04-19
DMF Number : 36600
Submission : 2021-12-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-02-15
Pay. Date : 2022-01-06
DMF Number : 36434
Submission : 2021-12-09
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40805
Submission : 2024-11-27
Status : Active
Type : II
Portfolio PDF
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Website
Corporate PDF
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PharmaCompass offers a list of Binimetinib 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 Binimetinib manufacturer or Binimetinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Binimetinib manufacturer or Binimetinib supplier.
PharmaCompass also assists you with knowing the Binimetinib API Price utilized in the formulation of products. Binimetinib API Price is not always fixed or binding as the Binimetinib Price is obtained through a variety of data sources. The Binimetinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Binimetinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Binimetinib, including repackagers and relabelers. The FDA regulates Binimetinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Binimetinib 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 Binimetinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Binimetinib supplier is an individual or a company that provides Binimetinib active pharmaceutical ingredient (API) or Binimetinib finished formulations upon request. The Binimetinib suppliers may include Binimetinib API manufacturers, exporters, distributors and traders.
click here to find a list of Binimetinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Binimetinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Binimetinib active pharmaceutical ingredient (API) in detail. Different forms of Binimetinib DMFs exist exist since differing nations have different regulations, such as Binimetinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Binimetinib DMF submitted to regulatory agencies in the US is known as a USDMF. Binimetinib USDMF includes data on Binimetinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Binimetinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Binimetinib suppliers with USDMF on PharmaCompass.
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