01 1Alkem Laboratories
02 1Apotex Pharmachem
03 1Esteve Quimica
04 1Glenmark Life Sciences
05 1Hetero Drugs
06 1ScinoPharm Taiwan, Ltd
07 1Standard Chem. & Pharm. Co., Ltd
08 1Sun Pharmaceutical Industries Limited
01 3RILUZOLE
02 5RILUZOLE USP
01 1Canada
02 1China
03 4India
04 1Spain
05 1Taiwan
01 7Active
02 1Inactive
01 3Complete
02 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25260
Submission : 2011-09-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22596
Submission : 2009-03-05
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-12
Pay. Date : 2013-07-10
DMF Number : 24693
Submission : 2011-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22107
Submission : 2008-10-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23215
Submission : 2009-10-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-02-23
Pay. Date : 2021-10-28
DMF Number : 15252
Submission : 2001-01-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-07
Pay. Date : 2013-04-08
DMF Number : 26147
Submission : 2012-06-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22438
Submission : 2009-03-16
Status : Active
Type : II
A Riluzole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Riluzole, including repackagers and relabelers. The FDA regulates Riluzole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Riluzole 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 Riluzole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Riluzole supplier is an individual or a company that provides Riluzole active pharmaceutical ingredient (API) or Riluzole finished formulations upon request. The Riluzole suppliers may include Riluzole API manufacturers, exporters, distributors and traders.
click here to find a list of Riluzole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Riluzole DMF (Drug Master File) is a document detailing the whole manufacturing process of Riluzole active pharmaceutical ingredient (API) in detail. Different forms of Riluzole DMFs exist exist since differing nations have different regulations, such as Riluzole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Riluzole DMF submitted to regulatory agencies in the US is known as a USDMF. Riluzole USDMF includes data on Riluzole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Riluzole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Riluzole suppliers with USDMF on PharmaCompass.
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