01 1Otsuka Holdings
01 1OPA-15406 DRUG SUBSTANCE
01 1Japan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30529
Submission : 2016-05-23
Status : Active
Type : II
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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