01 1Kyowa Kirin
02 1MSN Laboratories
03 1Procos
04 1Blank
01 3ISTRADEFYLLINE
02 1ISTRADEFYLLINE (KW-6002) DRUG SUBSTANCE
01 1India
02 1Italy
03 1Japan
04 1Blank
01 3Active
02 1Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23936
Submission : 2010-07-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38721
Submission : 2023-09-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38212
Submission : 2023-04-12
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40030
Submission : 2024-07-09
Status : Active
Type : II
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A Istradefylline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Istradefylline, including repackagers and relabelers. The FDA regulates Istradefylline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Istradefylline 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 Istradefylline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Istradefylline supplier is an individual or a company that provides Istradefylline active pharmaceutical ingredient (API) or Istradefylline finished formulations upon request. The Istradefylline suppliers may include Istradefylline API manufacturers, exporters, distributors and traders.
click here to find a list of Istradefylline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Istradefylline DMF (Drug Master File) is a document detailing the whole manufacturing process of Istradefylline active pharmaceutical ingredient (API) in detail. Different forms of Istradefylline DMFs exist exist since differing nations have different regulations, such as Istradefylline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Istradefylline DMF submitted to regulatory agencies in the US is known as a USDMF. Istradefylline USDMF includes data on Istradefylline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Istradefylline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Istradefylline suppliers with USDMF on PharmaCompass.
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