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 : 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 : 31090
Submission : 2016-12-27
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 Jtk 303 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Jtk 303, including repackagers and relabelers. The FDA regulates Jtk 303 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Jtk 303 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 Jtk 303 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Jtk 303 supplier is an individual or a company that provides Jtk 303 active pharmaceutical ingredient (API) or Jtk 303 finished formulations upon request. The Jtk 303 suppliers may include Jtk 303 API manufacturers, exporters, distributors and traders.
click here to find a list of Jtk 303 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Jtk 303 DMF (Drug Master File) is a document detailing the whole manufacturing process of Jtk 303 active pharmaceutical ingredient (API) in detail. Different forms of Jtk 303 DMFs exist exist since differing nations have different regulations, such as Jtk 303 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Jtk 303 DMF submitted to regulatory agencies in the US is known as a USDMF. Jtk 303 USDMF includes data on Jtk 303's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Jtk 303 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Jtk 303 suppliers with USDMF on PharmaCompass.
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