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List of Drug Master Files (DMF) of Irbesartan Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 EUROAPI (1)

02 Sanofi (1)

03 Ajinomoto Company (1)

04 Alembic Pharmaceuticals Limited (1)

05 Aurobindo Pharma Limited (1)

06 Bristol Myers Squibb (2)

07 CTX Lifesciences (1)

08 Cadila Pharmaceuticals (1)

09 Calyx Chemicals & Pharmaceuticals Limited (1)

10 Cipla (1)

11 Divis Laboratories (1)

12 Dynamit Nobel GmbH Explosivstoff- und Systemtechnik (1)

13 HEC Pharm (1)

14 Hetero Drugs (2)

15 Jubilant Generics (1)

16 Lupin Ltd (2)

17 MSN Laboratories (1)

18 Macleods Pharmaceuticals Limited (1)

19 Micro Labs Limited (1)

20 Piramal Pharma Solutions (1)

21 Quimica Sintetica S.A. (1)

22 RANBAXY LABORATORIES LIMITED (1)

23 Siegfried AG (1)

24 Signa S.A. de C.V. (1)

25 Teva API (2)

26 ULKAR KIMYA SANAYII VE TICARET (1)

27 Unichem Laboratories Limited (1)

28 Viatris (1)

29 Zhejiang Apeloa Jiayuan Pharmaceutical (1)

30 Zhejiang Huahai Pharmaceutical (2)

31 Zhuhai Rundu Pharmaceutical (2)

32 Zydus Lifesciences (2)

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01 IRBESARTAN (10)

02 IRBESARTAN (FORM A) PROCESS I (1)

03 IRBESARTAN (FORM A) PROCESS II (1)

04 IRBESARTAN (POLYMORPHIC FORM-A) (1)

05 IRBESARTAN API (1)

06 IRBESARTAN CRUDE (1)

07 IRBESARTAN DRUG SUBSTANCE (2)

08 IRBESARTAN NON-STERILE BULK DRUG SUBSTANCE (1)

09 IRBESARTAN USP (16)

10 IRBESARTAN USP (NON-STERILE DRUG SUBSTANCE) (1)

11 IRBESARTAN USP (PROCESS B) (1)

12 IRBESARTAN(SR47436) (1)

13 IRBESARTAN, NON-STERILE BULK DRUG SUBSTANCE (1)

14 SR 47436 (CRUDE) (1)

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01 China (6)

02 France (2)

03 Germany (1)

04 India (19)

05 Israel (2)

06 Japan (1)

07 Mexico (1)

08 Spain (1)

09 Switzerland (1)

10 Turkey (1)

11 U.S.A (4)

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01 Active (22)

02 Inactive (17)

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01 Complete (12)

02 Blank (27)

URL Supplier Web Content
10310
Active
1993-06-30
N/A
II
Sanofi Company Banner

ICRI Spring Convention

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
20378
Active
2007-03-19
N/A
II
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23084
Active
2009-08-31
Complete
2013-01-09
2012-12-17
II
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17507
Active
2004-07-02
Complete
2016-05-27
2016-05-12
II
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19790
Active
2006-09-14
Complete
2013-03-27
2013-03-01
II
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17394
Active
2004-05-18
N/A
II
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17912
Active
2004-12-20
N/A
II
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21780
Active
2008-05-28
Complete
2013-09-29
2013-09-24
II
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URL Supplier Web Content
20361
Active
2007-03-22
N/A
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Looking for 138402-11-6 / Irbesartan API manufacturers, exporters & distributors?

Irbesartan manufacturers, exporters & distributors 1

89

PharmaCompass offers a list of Irbesartan API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Irbesartan manufacturer or Irbesartan supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Irbesartan manufacturer or Irbesartan supplier.

PharmaCompass also assists you with knowing the Irbesartan API Price utilized in the formulation of products. Irbesartan API Price is not always fixed or binding as the Irbesartan Price is obtained through a variety of data sources. The Irbesartan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Irbesartan

Synonyms

138402-11-6, Avapro, Aprovel, Karvea, Sr-47436, Bms-186295

Cas Number

138402-11-6

Unique Ingredient Identifier (UNII)

J0E2756Z7N

About Irbesartan

A spiro compound, biphenyl and tetrazole derivative that acts as an angiotensin II type 1 receptor antagonist. It is used in the management of HYPERTENSION, and in the treatment of kidney disease.

Irbesartan Manufacturers

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.

Irbesartan Suppliers

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.

Irbesartan USDMF

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.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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