01 1Hefei TianRui Pharmaceutical Chemical
02 1Otsuka Holdings
01 1DIFAMILAST
02 1OPA-15406 DRUG SUBSTANCE
01 1China
02 1Japan
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42168
Submission : 2025-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30529
Submission : 2016-05-23
Status : Active
Type : II
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PharmaCompass offers a list of Difamilast 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 Difamilast manufacturer or Difamilast supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Difamilast manufacturer or Difamilast supplier.
PharmaCompass also assists you with knowing the Difamilast API Price utilized in the formulation of products. Difamilast API Price is not always fixed or binding as the Difamilast Price is obtained through a variety of data sources. The Difamilast Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Difamilast manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Difamilast, including repackagers and relabelers. The FDA regulates Difamilast manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Difamilast 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 Difamilast manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Difamilast supplier is an individual or a company that provides Difamilast active pharmaceutical ingredient (API) or Difamilast finished formulations upon request. The Difamilast suppliers may include Difamilast API manufacturers, exporters, distributors and traders.
click here to find a list of Difamilast suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Difamilast DMF (Drug Master File) is a document detailing the whole manufacturing process of Difamilast active pharmaceutical ingredient (API) in detail. Different forms of Difamilast DMFs exist exist since differing nations have different regulations, such as Difamilast USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Difamilast DMF submitted to regulatory agencies in the US is known as a USDMF. Difamilast USDMF includes data on Difamilast's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Difamilast USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Difamilast suppliers with USDMF on PharmaCompass.
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