01 1Acebright India Pharma Private Limited
02 2Arene Lifesciences
03 2Aurobindo Pharma Limited
04 1Cipla
05 2Emcure Pharmaceuticals
06 4Hetero Drugs
07 2Laurus Labs
08 1Lupin Ltd
09 1Macleods Pharmaceuticals Limited
10 1RANBAXY LABORATORIES LIMITED
11 1SEQUENT SCIENTIFIC LTD
12 1SIBRA PHARMACEUTICALS LTD
13 1SMS Pharmaceuticals
14 1Shanghai Desano Bio-Pharmaceutical
15 5Viatris
16 1Zhejiang Huahai Pharmaceutical
17 1Zhejiang Jiangbei Pharmaceutical
01 5EFAVIRENZ
02 1EFAVIRENZ (ALTERNATE PROCESS)
03 1EFAVIRENZ (PROCESS I)
04 1EFAVIRENZ (PROCESS II)
05 1EFAVIRENZ (PROCESS III) USP
06 12EFAVIRENZ USP
07 1EFAVIRENZ USP (NON-STERILE DRUG SUBSTANCE)
08 1EFAVIRENZ USP (PROCESS - II)
09 1EFAVIRENZ USP (PROCESS-2)
10 1EFAVIRENZ USP (PROCESS-III)
11 1EFAVIRENZ USP (PROCESS-IV)
12 1EFAVIRENZ [DRUG SUBSTANCE (NON-STERILE)]
13 1EFAVIRENZ(FORM-H1)
01 3China
02 20India
03 5U.S.A
01 19Active
02 9Inactive
01 14Complete
02 14Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-17
Pay. Date : 2013-05-08
DMF Number : 24847
Submission : 2011-04-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19932
Submission : 2006-10-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-07-31
Pay. Date : 2015-07-28
DMF Number : 17802
Submission : 2004-10-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-31
Pay. Date : 2014-03-19
DMF Number : 20711
Submission : 2008-04-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-09
Pay. Date : 2012-12-21
DMF Number : 24943
Submission : 2011-05-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-26
Pay. Date : 2012-12-04
DMF Number : 20015
Submission : 2006-12-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-31
Pay. Date : 2013-01-11
DMF Number : 21964
Submission : 2008-09-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21666
Submission : 2008-05-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-27
Pay. Date : 2013-02-04
DMF Number : 23271
Submission : 2009-11-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-28
Pay. Date : 2013-08-20
DMF Number : 18230
Submission : 2005-03-30
Status : Active
Type : II
A Efavirenz manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Efavirenz, including repackagers and relabelers. The FDA regulates Efavirenz manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Efavirenz 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 Efavirenz manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Efavirenz supplier is an individual or a company that provides Efavirenz active pharmaceutical ingredient (API) or Efavirenz finished formulations upon request. The Efavirenz suppliers may include Efavirenz API manufacturers, exporters, distributors and traders.
click here to find a list of Efavirenz suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Efavirenz DMF (Drug Master File) is a document detailing the whole manufacturing process of Efavirenz active pharmaceutical ingredient (API) in detail. Different forms of Efavirenz DMFs exist exist since differing nations have different regulations, such as Efavirenz USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Efavirenz DMF submitted to regulatory agencies in the US is known as a USDMF. Efavirenz USDMF includes data on Efavirenz's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Efavirenz USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Efavirenz suppliers with USDMF on PharmaCompass.
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