Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
01 1Chunghwa Chemical Synthesis & Biotech
02 1MSN Laboratories
03 1Blank
01 3SELUMETINIB SULFATE
01 1India
02 1Taiwan
03 1Blank
01 3Active
01 3Blank
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41492
Submission : 2025-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43833
Submission : 2026-03-29
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43936
Submission : 2026-03-31
Status : Active
Type : II
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PharmaCompass offers a list of Selumetinib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Selumetinib manufacturer or Selumetinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Selumetinib manufacturer or Selumetinib supplier.
A Selumetinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Selumetinib, including repackagers and relabelers. The FDA regulates Selumetinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Selumetinib 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 Selumetinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Selumetinib supplier is an individual or a company that provides Selumetinib active pharmaceutical ingredient (API) or Selumetinib finished formulations upon request. The Selumetinib suppliers may include Selumetinib API manufacturers, exporters, distributors and traders.
click here to find a list of Selumetinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Selumetinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Selumetinib active pharmaceutical ingredient (API) in detail. Different forms of Selumetinib DMFs exist exist since differing nations have different regulations, such as Selumetinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Selumetinib DMF submitted to regulatory agencies in the US is known as a USDMF. Selumetinib USDMF includes data on Selumetinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Selumetinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Selumetinib suppliers with USDMF on PharmaCompass.
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