EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
01 1EUROAPI
02 1Sanofi
03 2TAPI Technology & API Services
04 1Ajinomoto Company
05 1Alembic Pharmaceuticals Limited
06 1Aurobindo Pharma Limited
07 2Bristol Myers Squibb
08 1CTX Lifesciences
09 1Cadila Pharmaceuticals
10 1Calyx Chemicals & Pharmaceuticals Limited
11 1Cipla
12 2Divis Laboratories
13 1Dynamit Nobel GmbH Explosivstoff- und Systemtechnik
14 1HEC Pharm
15 2Hetero Drugs
16 1Jubilant Generics
17 2Lupin Ltd
18 1MSN Laboratories
19 1Macleods Pharmaceuticals Limited
20 1Micro Labs Limited
21 1Piramal Pharma Solutions
22 1Quimica Sintetica
23 1RANBAXY LABORATORIES LIMITED
24 1Siegfried AG
25 1Signa S.A. de C.V.
26 1Synergene Active Ingredients Pvt Ltd
27 1ULKAR KIMYA SANAYII VE TICARET
28 1Unichem Laboratories Limited
29 1Viatris
30 1Zhejiang Apeloa Jiayuan Pharmaceutical
31 2Zhejiang Huahai Pharmaceutical
32 2Zhuhai Rundu Pharmaceutical
33 2Zydus Lifesciences
01 10IRBESARTAN
02 1IRBESARTAN (FORM A) PROCESS I
03 1IRBESARTAN (FORM A) PROCESS II
04 1IRBESARTAN (POLYMORPHIC FORM-A)
05 1IRBESARTAN API
06 1IRBESARTAN CRUDE
07 2IRBESARTAN DRUG SUBSTANCE
08 1IRBESARTAN NON-STERILE BULK DRUG SUBSTANCE
09 18IRBESARTAN USP
10 1IRBESARTAN USP (NON-STERILE DRUG SUBSTANCE)
11 1IRBESARTAN USP (PROCESS B)
12 1IRBESARTAN(SR47436)
13 1IRBESARTAN, NON-STERILE BULK DRUG SUBSTANCE
14 1SR 47436 (CRUDE)
01 6China
02 2France
03 1Germany
04 21India
05 2Israel
06 1Japan
07 1Mexico
08 1Spain
09 1Switzerland
10 1Turkey
11 4U.S.A
01 23Active
02 18Inactive
01 11Complete
02 30Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19690
Submission : 2006-08-15
Status : Active
Type : II
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10310
Submission : 1993-06-30
Status : Active
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17394
Submission : 2004-05-18
Status : Active
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-09
DMF Number : 25483
Submission : 2011-11-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20378
Submission : 2007-03-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-27
Pay. Date : 2016-05-12
DMF Number : 17507
Submission : 2004-07-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-27
Pay. Date : 2013-03-01
DMF Number : 19790
Submission : 2006-09-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17912
Submission : 2004-12-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-29
Pay. Date : 2013-09-24
DMF Number : 21780
Submission : 2008-05-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20361
Submission : 2007-03-22
Status : Active
Type : II
A Irbesartan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Irbesartan, including repackagers and relabelers. The FDA regulates Irbesartan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Irbesartan 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 Irbesartan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Irbesartan supplier is an individual or a company that provides Irbesartan active pharmaceutical ingredient (API) or Irbesartan finished formulations upon request. The Irbesartan suppliers may include Irbesartan API manufacturers, exporters, distributors and traders.
click here to find a list of Irbesartan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Irbesartan DMF (Drug Master File) is a document detailing the whole manufacturing process of Irbesartan active pharmaceutical ingredient (API) in detail. Different forms of Irbesartan DMFs exist exist since differing nations have different regulations, such as Irbesartan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Irbesartan DMF submitted to regulatory agencies in the US is known as a USDMF. Irbesartan USDMF includes data on Irbesartan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Irbesartan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Irbesartan suppliers with USDMF on PharmaCompass.
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