01 1Gilead Sciences
02 1HONOUR LAB LTD
03 1MSN Laboratories
04 2Viatris
01 1COBICISTAT ON COLLOIDAL SILICON DIOXIDE
02 3COBICISTAT ON SILICON DIOXIDE
03 1COBICISTAT ON SILICON DIOXIDE (PROCESS-II)
01 2India
02 3U.S.A
01 5Active
01 4Complete
02 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25188
Submission : 2011-10-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-10-21
Pay. Date : 2016-08-16
DMF Number : 30287
Submission : 2016-09-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-16
Pay. Date : 2018-01-05
DMF Number : 30650
Submission : 2016-07-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-20
Pay. Date : 2014-07-28
DMF Number : 28438
Submission : 2014-08-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-14
Pay. Date : 2015-08-31
DMF Number : 29615
Submission : 2015-09-02
Status : Active
Type : II
A Cobicistat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cobicistat, including repackagers and relabelers. The FDA regulates Cobicistat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cobicistat 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 Cobicistat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cobicistat supplier is an individual or a company that provides Cobicistat active pharmaceutical ingredient (API) or Cobicistat finished formulations upon request. The Cobicistat suppliers may include Cobicistat API manufacturers, exporters, distributors and traders.
click here to find a list of Cobicistat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cobicistat DMF (Drug Master File) is a document detailing the whole manufacturing process of Cobicistat active pharmaceutical ingredient (API) in detail. Different forms of Cobicistat DMFs exist exist since differing nations have different regulations, such as Cobicistat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cobicistat DMF submitted to regulatory agencies in the US is known as a USDMF. Cobicistat USDMF includes data on Cobicistat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cobicistat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cobicistat suppliers with USDMF on PharmaCompass.
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