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List of Certificates of Suitability (CEPs) for Irbesartan Active Pharmaceutical Ingredient (API) issued by the EDQM. Original Data: EDQM Database

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01 EUROAPI HUNGARY Ltd. Budapest HU (1)

02 Sanofi Winthrop Industrie Gentilly FR (1)

03 ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN (1)

04 APITORIA PHARMA PRIVATE LIMITED Hyderabad IN (1)

05 AUROBINDO PHARMA LIMITED Hyderabad IN (1)

06 CTX LIFESCIENCES PVT. LIMITED Surat IN (1)

07 DIVI'S LABORATORIES LIMITED Hyderabad IN (1)

08 DR. REDDY'S LABORATORIES LIMITED Hyderabad IN (1)

09 HETERO LABS LIMITED Hyderabad IN (1)

10 JUBILANT PHARMOVA LIMITED Nanjangud IN (1)

11 MACLEODS PHARMACEUTICALS LIMITED Mumbai IN (1)

12 MICRO LABS LIMITED Bengaluru IN (2)

13 MSN LIFE SCIENCES PRIVATE LIMITED Chandampet Village IN (1)

14 MYLAN LABORATORIES LIMITED Hyderabad IN (2)

15 SIGNA S.A. DE C.V. Toluca MX (1)

16 SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN (1)

17 TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL (4)

18 Ulkar Kimya Sanayii Ve Ticaret Anonim Sirketi Umraniye TR (1)

19 Unichem Laboratories Limited Mumbai IN (1)

20 ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Linhai CN (1)

21 ZHEJIANG TIANYU PHARMACEUTICAL CO., LTD. Taizhou City CN (1)

22 ZHUHAI RUNDU PHARMACEUTICAL CO., LTD. Zhuhai City CN (2)

23 Zhejiang Kinglyuan Pharmaceutical Co., Ltd. Shangyu CN (1)

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01 Irbesartan (22)

02 Irbesartan, CHINOIN (1)

03 Irbesartan, Code 8711 (1)

04 Irbesartan, Process 2 (1)

05 Irbesartan, Process II (4)

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01 China (3)

02 France (2)

03 India (14)

04 Israel (4)

05 Mexico (1)

06 Turkey (1)

07 U.S.A (2)

08 Blank (2)

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01 Expired (2)

02 Valid (24)

03 Withdrawn by Holder (3)

URL Supplier Web Content
CEP 2017-160 - Rev 01
Valid
Chemical
2024-02-14
2465
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CPhI Japan

Not Confirmed

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URL Supplier Web Content
R1-CEP 2012-339 - Rev 03
Valid
Chemical
2021-11-08
2465
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URL Supplier Web Content
CEP 2017-104 - Rev 04
Valid
Chemical
2024-03-25
2465
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CEP 2011-087 - Rev 04
Valid
Chemical
2024-03-25
2465
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CEP 2011-046 - Rev 05
Valid
Chemical
2023-11-07
2465
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R0-CEP 2021-351 - Rev 00
Valid
Chemical
2023-01-18
2465
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R1-CEP 2010-195 - Rev 08
Valid
Chemical
2023-04-28
2465
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R1-CEP 2012-233 - Rev 02
Valid
Chemical
2021-07-23
2465
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ZHUHAI RUNDU PHARMACEUTICAL CO., LT...

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CEP 2017-151 - Rev 05
Valid
Chemical
2024-03-20
2465
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Looking for 138402-11-6 / Irbesartan API manufacturers, exporters & distributors?

Irbesartan manufacturers, exporters & distributors 1

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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 CEP

A Irbesartan CEP of the European Pharmacopoeia monograph is often referred to as a Irbesartan Certificate of Suitability (COS). The purpose of a Irbesartan CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Irbesartan EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Irbesartan to their clients by showing that a Irbesartan CEP has been issued for it. The manufacturer submits a Irbesartan CEP (COS) as part of the market authorization procedure, and it takes on the role of a Irbesartan CEP holder for the record. Additionally, the data presented in the Irbesartan CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Irbesartan DMF.

A Irbesartan CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Irbesartan CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Irbesartan suppliers with CEP (COS) 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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