01 1Alembic Pharmaceuticals Limited
02 1Gilead Sciences
03 2MSN Laboratories
04 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
05 2Viatris
01 4ELVITEGRAVIR
02 1ELVITEGRAVIR (FORM-I)
03 1ELVITEGRAVIR (FORM-II)
04 1ELVITEGRAVIR (PROCESS-II)
01 1China
02 3India
03 3U.S.A
01 7Active
01 3Complete
02 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34649
Submission : 2020-03-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25187
Submission : 2011-10-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31090
Submission : 2016-12-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-08
Pay. Date : 2016-09-29
DMF Number : 30772
Submission : 2016-08-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32456
Submission : 2017-12-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-22
Pay. Date : 2015-07-28
DMF Number : 29558
Submission : 2015-08-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-31
Pay. Date : 2013-12-09
DMF Number : 27727
Submission : 2013-12-27
Status : Active
Type : II
A Elvitegravir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Elvitegravir, including repackagers and relabelers. The FDA regulates Elvitegravir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Elvitegravir 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 Elvitegravir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Elvitegravir supplier is an individual or a company that provides Elvitegravir active pharmaceutical ingredient (API) or Elvitegravir finished formulations upon request. The Elvitegravir suppliers may include Elvitegravir API manufacturers, exporters, distributors and traders.
click here to find a list of Elvitegravir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Elvitegravir DMF (Drug Master File) is a document detailing the whole manufacturing process of Elvitegravir active pharmaceutical ingredient (API) in detail. Different forms of Elvitegravir DMFs exist exist since differing nations have different regulations, such as Elvitegravir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Elvitegravir DMF submitted to regulatory agencies in the US is known as a USDMF. Elvitegravir USDMF includes data on Elvitegravir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Elvitegravir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Elvitegravir suppliers with USDMF on PharmaCompass.
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