01 2Aurobindo Pharma Limited
02 1Cipla
03 2Hetero Drugs
04 2Laurus Labs
05 2Lupin Ltd
06 1Olon S.p.A
07 1Signa S.A. de C.V.
08 1Viatris
01 2ABACAVIR SULFATE
02 1ABACAVIR SULFATE (PROCESS-II), USP
03 5ABACAVIR SULFATE USP
04 1ABACAVIR SULFATE USP (PROCESS II)
05 2ABACAVIR SULFATE USP (PROCESS-2)
06 1ABACAVIR SULFATE, USP
01 9India
02 1Italy
03 1Mexico
04 1U.S.A
01 11Active
02 1Inactive
01 10Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-04
Pay. Date : 2013-08-21
DMF Number : 18256
Submission : 2005-03-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-29
Pay. Date : 2013-03-13
DMF Number : 26299
Submission : 2012-08-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-27
Pay. Date : 2015-12-21
DMF Number : 29587
Submission : 2015-07-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-15
Pay. Date : 2013-01-24
DMF Number : 22196
Submission : 2008-11-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-27
Pay. Date : 2018-08-23
DMF Number : 33031
Submission : 2018-08-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-20
Pay. Date : 2014-11-21
DMF Number : 28818
Submission : 2014-12-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-27
Pay. Date : 2012-11-20
DMF Number : 23618
Submission : 2010-04-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20515
Submission : 2007-05-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-15
Pay. Date : 2014-07-07
DMF Number : 23644
Submission : 2010-03-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-16
Pay. Date : 2017-05-11
DMF Number : 18229
Submission : 2005-03-30
Status : Active
Type : II
A Abacavir Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Abacavir Sulfate, including repackagers and relabelers. The FDA regulates Abacavir Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Abacavir Sulfate 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 Abacavir Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Abacavir Sulfate supplier is an individual or a company that provides Abacavir Sulfate active pharmaceutical ingredient (API) or Abacavir Sulfate finished formulations upon request. The Abacavir Sulfate suppliers may include Abacavir Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Abacavir Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Abacavir Sulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Abacavir Sulfate active pharmaceutical ingredient (API) in detail. Different forms of Abacavir Sulfate DMFs exist exist since differing nations have different regulations, such as Abacavir Sulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Abacavir Sulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Abacavir Sulfate USDMF includes data on Abacavir Sulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Abacavir Sulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Abacavir Sulfate suppliers with USDMF on PharmaCompass.
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