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Irbesartan

CAS number: 138402-11-6

Molecular formula: C25H28N6O

molecular weight: 428.53

Chemical structure:

Producers shown on SFDA

(Record date:02/09/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Zhejiang Kinglyuan Pharmaceutical Co., Ltd.

GMP
Valid till August 2023

Zhejiang Apeloa Jiayuan Pharmaceutical Co., Ltd.

GMP
Valid till December 2022

 Weightech (Hunan) Pharmaceutical Co., Ltd.

GMP
Valid till September 2020

Zhejiang Huahai Pharmaceutical Co., Ltd.

GMP, DMF, CEP
Valid till September 2019

Zhejiang Tianyu Pharmaceutical Co., Ltd.

GMP

Valid till January 2023

Livzon Syntpharm Co.,Ltd.(zhuhaiftz)

GMP
Valid till February 2020

Xiuzheng Pharmaceutical Group Liuhe Pharmaceutical Co., Ltd.

GMP
Valid till December 2019

Zhuhai Rundu Pharmaceutical Co., Ltd.

GMP
Valid till November 2021


Producers shown on EP

(Quoted from EP website;record date:02/09/2021)

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Irbesartan
Ulkar Kimya Sanayii Ve Ticaret Anonim Sirketi TR 34768 Umraniye
  R0-CEP 2012-156-Rev 00
21/05/2015
SUSPENDED
27/01/2020
Chemistry
Irbesartan CHINOIN 
CHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO., LTD. HU 1045 Budapest
  R0-CEP 2020-101-Rev 00
  R0-CEP 2020-101-Rev 00
VALID
/Chemistry
Irbesartan
HETERO LABS LIMITED IN 500 018 Hyderabad
  R0-CEP 2017-104-Rev 01
18/02/2020
VALID
/
Chemistry
IrbesartanSANOFI CHIMIE FR 94250 Gentilly
  R0-CEP 2017-160-Rev 04
27/08/2021
VALID
/
Chemistry
Irbesartan
Zhejiang Kinglyuan Pharmaceutical Co., Ltd. CN 312 369 Shangyu
  R0-CEP 2014-029-Rev 00
17/04/2015
SUSPENDED
27/01/2020
Chemistry
Irbesartan
CTX LIFE SCIENCES PVT. LIMITED IN 394 230 Surat
  R1-CEP 2011-139-Rev 04
09/08/2021
VALID
/
Chemistry
Irbesartan Process II
MICRO LABS LIMITED IN 560 001 Bengaluru
  R0-CEP 2020-260-Rev 00
17/12/2020
VALID
/
Chemistry
Irbesartan
SUN PHARMACEUTICAL INDUSTRIES LIMITED IN 400 063 Mumbai
  R1-CEP 2010-195-Rev 04
11/06/2020
VALID
/
Chemistry
Irbesartan
MICRO LABS LIMITED IN 560 001 Bengaluru
  R1-CEP 2011-176-Rev 03
03/02/2020
WITHDRAWN BY HOLDER
10/06/2021
Chemistry
Irbesartan
AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad
  R1-CEP 2009-283-Rev 06
23/01/2020
VALID
/
Chemistry
Irbesartan
ZHUHAI RUNDU PHARMACEUTICAL CO., LTD. CN 519 041 Sanzao
  R0-CEP 2017-151-Rev 03
15/01/2021
VALID
/
Chemistry
Irbesartan
TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva
  R1-CEP 2011-251-Rev 03
03/03/2021
VALID
/
Chemistry
Irbesartan
SIGNA S.A. DE C.V. MX 50071 Toluca
  R1-CEP 2010-327-Rev 03
08/01/2020
WITHDRAWN BY HOLDER
02/11/2020
Chemistry
Irbesartan Code 8711
TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva
  R1-CEP 2013-155-Rev 00
12/08/2019
VALID
/
Chemistry
Irbesartan
ALEMBIC PHARMACEUTICALS LIMITED IN 390 003 Vadodara
  R1-CEP 2011-153-Rev 03
30/08/2021
VALID
/
Chemistry
Irbesartan
Unichem Laboratories Limited IN 400 102 Mumbai
  R1-CEP 2011-151-Rev 01
08/10/2019
VALID
/
Chemistry
Irbesartan
JUBILANT GENERICS LIMITED IN 571 302 Nanjangud
  R1-CEP 2011-087-Rev 01
16/01/2020
VALID
/
Chemistry
Irbesartan
MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad
  R1-CEP 2010-124-Rev 05
10/06/2021
VALID
/
Chemistry
Irbesartan
DIVI'S LABORATORIES LIMITED IN 500 032 Hyderabad
  R1-CEP 2012-339-Rev 02
06/11/2019
VALID
/
Chemistry
Irbesartan
ZHEJIANG TIANYU PHARMACEUTICAL CO., LTD. CN 318 020 Taizhou City
  R1-CEP 2012-233-Rev 02
23/07/2021
VALID
/
Chemistry
Irbesartan
DR. REDDY'S LABORATORIES LIMITED IN 500 034 Hyderabad
  R1-CEP 2010-067-Rev 01
11/12/2019
VALID
/
Chemistry
Irbesartan
TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva
  R1-CEP 2010-322-Rev 01
03/10/2019
VALID
/
Chemistry
Irbesartan
ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. CN 317 024 Linhai
  R1-CEP 2010-033-Rev 03
05/05/2021
VALID
/
Chemistry
Irbesartan
MACLEODS PHARMACEUTICALS LIMITED IN 400 059 Mumbai
  R1-CEP 2011-046-Rev 03
23/03/2021
VALID
/
Chemistry

Producer:Zhejiang Kinglyuan Pharmaceutical Co., Ltd.is located on the Bank of Hangzhou Bay, Zhejiang Province, with beautiful scenery, pleasant climate and superior geographical location. The company covers an area of 180000 square meters, has assets of 680 million yuan, and has 560 employees, including 32 with senior professional titles, and intermediate and other relevant technicians account for 42% of the total number of employees. After more than ten years of development, the company has become a comprehensive pharmaceutical enterprise integrating R & D, production and service.

Staff size:About 560 persons

Registered capital:RMB 68.2 million


Producer:Zhuhai Rundu Pharmaceutical Co., Ltd. is a modern scientific and technological pharmaceutical enterprise integrating drug R & D, production and sales. It is located in Jinwan District, Zhuhai City, Guangdong Province. It was established in 1999. On January 5, 2018, the company was listed on Shenzhen Stock Exchange

The company has a sound quality management system and has established a drug production and manufacturing center in strict accordance with the national GMP requirements. The existing product production lines (including APIs, tablets, capsules, preparation intermediates (pellets), etc.) have passed the new national GMP certification, and some characteristic API products have passed the official certification of the World Health Organization, the European Union and Japan, Some products have passed the on-site inspection of FDA.

Staff size:About 2000 persons

Registered capital:RMB 185 million 700 thousand


Producer:Zhejiang Apeloa Jiayuan Pharmaceutical Co., Ltd is subordinate to Apeloa Pharmaceutical Co., Ltd

Apeloa Pharmaceutical Co., Ltd. is a large comprehensive pharmaceutical enterprise integrating research, development and production of API intermediates, cdmo (contract R & D and production services) and preparations. It is an industrial and financial platform for pharmaceutical business of Hengdian group.

The company has established three competitive management systems of technology, EHS and quality for API intermediates, and has gradually formed strong market competitive advantages in cost, quality and technology. At the same time, it actively implemented the international development strategy and set up business branches in the United States and Hong Kong to provide high-quality services and establish long-term cooperative relations for mainstream pharmaceutical enterprises at home and abroad. The company's main factories have been certified by FDA of the United States, PMDA of Japan and EU. With its comprehensive strength in the chemical pharmaceutical industry, PLO pharmaceutical ranks 21st among the top 100 chemical pharmaceutical enterprises in China.

Staff size:1000-1999 persons

Registered capital:RMB 126.5 million


Producer:Weightech (Hunan) Pharmaceutical Co., Ltd.is a Sino foreign joint venture pharmaceutical enterprise, established in 2003, The production base is located in Changsha National biological industry base, with a planned area of 66000m2. Solid preparation workshop and API workshop including three production lines of tablets, capsules and granules have been built, and have successively passed the national GMP certification.

Staff size:100-199 persons

Registered capital:RMB 10 million


Producer:Zhejiang Huahai Pharmaceutical Co., Ltd.was founded in 1989 and headquartered in Zhejiang, China. The company has nearly 7000 employees and more than 40 subsidiaries around the world (including China, the United States, Japan, Germany, etc.As a leading enterprise in the internationalization of Chinese medicine, Huahai pharmaceutical is the first pharmaceutical company in China to pass the FDA preparation quality certification and independently own the Anda document number. It is also the first Chinese pharmaceutical company to realize large-scale preparation sales in the United States. It has established China's pharmaceutical quality image in the world's high-end pharmaceutical market.

Staff size:About 7000 persons

Registered capital:RMB 1 billion 492 million


Producer:Zhejiang Tianyu Pharmaceutical Co., Ltd., founded in 2003, is headquartered in Taizhou, Zhejiang, with a registered capital of more than 180 million yuan. It has six wholly-owned subsidiaries and more than 3800 employees. Tianyu Co., Ltd. is a joint-stock pharmaceutical enterprise specializing in R & D, manufacturing and sales of APIs and advanced pharmaceutical intermediates. It was successfully listed on Shenzhen Stock Exchange on September 19, 2017.

The company's main products include antihypertensive, hypoglycemic, antithrombotic and antiasthmatic drug raw materials and intermediates. It is one of the world's major manufacturers of cardiovascular raw materials, and its products sell well in markets at home and abroad.

Staff size:About 4000 persons

Registered capital:RMB 348 million


Producer:Livzon Syntpharm Co.,Ltd.(zhuhaiftz) a wholly-owned subsidiary of Lizhu Pharmaceutical Group Co., Ltd., was established in 1993 and is located in Zhuhai Free Trade Zone, Guangdong Province. By the end of 2008, the company had invested more than 300 million yuan in fixed assets, covering an area of about 100000 square meters. It is a API base based on cephalosporin semi synthetic antibiotics built according to GMP standards. The production lines of the whole company have passed GMP certification.

The company has nearly 500 employees. Its main products include ceftriaxone sodium, cefuroxime sodium, cefdixone sodium, ceftazidime, cefepime hydrochloride and cefpirome sulfate. The total annual capacity is 680 tons. The production process and economic and technical indexes of all products have reached the domestic advanced level, and the product quality meets the CP and USP Pharmacopoeia standards.

Staff size:400-499 persons

Registered capital:RMB 128.28 million


Producer:Xiuzheng Pharmaceutical Group Liuhe Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Jilin amendment Pharmaceutical Group, was established in 2000. It is a GMP certified enterprise with import and export qualification.

The company has total assets of 31.9 million yuan, covers an area of 19000 square meters, a construction area of 9696 square meters, and has 188 employees,   50 professional technicians. There are two API production workshops and 9 specialized API production lines. The company can produce 500 tons of various APIs every year.

Staff size:100-199 persons

Registered capital:RMB 3 million


For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +86 18402846978