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Telmisartan

CAS number: 144701-48-4

Molecular formula: C33H30N4O2

molecular weight: 514.617

Chemical structure:

Producers shown on SFDA

(Record date:02/09/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Jiangsu Zhongbang Pharmaceutical Co., Ltd.

GMP, DMF
Valid till September 2020

Zhejiang Kinglyuan Pharmaceutical Co., Ltd.

GMP
Valid till November 2024

Topharman Shandong Co., Ltd.

GMP
Valid till November 2023

Yichang HEC Changjiang Pharmaceutical Co., Ltd.

GMP
Valid till March 2023

Weightech (Hunan) Pharmaceutical Co., Ltd.i

GMP
Valid till February 2020

Zhejiang Apeloa Jiayuan Pharmaceutical Co., Ltd. 

GMP
Valid till August 2021

Chongqing Conquer Pharmaceutical Co., Ltd.

GMP
Valid till January 2019

Shandong Xinyi Pharmaceutical Co., Ltd.

GMP
Valid till October 2023

Shandong Qidu Pharmaceutical Co., Ltd. 

GMP
Valid till August 2020

Hunan Dino Pharmaceutical Co., Ltd.

GMP
Valid till May 2021

Beijing Shuanglu Pharmaceutical Co., Ltd.

GMP
Valid till March 2022

Dongzhitang Pharmaceutical (Anhui) Co., Ltd.

GMP
Valid till November 2024

Changzhou Pharmaceutical Factory Co., Ltd.

GMP
Valid tillJuly 2023

Fuzhou Haiwang Fuyao Pharmaceutical Co., Ltd.

GMP
Valid till November 2019

Changzhou Yabang Pharmaceutical Co., Ltd.

GMP
Valid till June 2024


Producers shown on EP

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

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Telmisartan
WATSON PHARMA PRIVATE LIMITED IN 400 059 Mumbai
  R0-CEP 2010-261-Rev 00
22/01/2013
WITHDRAWN BY EDQM
13/12/2013
Chemistry
Telmisartan Site II
AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad
  R0-CEP 2020-290-Rev 00
09/12/2020
VALID
/Chemistry
Telmisartan
TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva
  R1-CEP 2010-301-Rev 02
24/06/2020
VALID
/
Chemistry
Telmisartan
GRANULES INDIA LIMITED IN 500 081 Hyderabad
  R0-CEP 2011-355-Rev 01
29/01/2015
WITHDRAWN BY HOLDER
03/01/2018
Chemistry
Telmisartan
DR. REDDY'S LABORATORIES LIMITED IN 500 034 Hyderabad
  R1-CEP 2010-165-Rev 02
28/06/2018
VALID
/
Chemistry
Telmisartan
Jiangxi Synergy Pharmaceutical Co., Ltd. CN 330 700 Fengxin
  R1-CEP 2013-135-Rev 00
17/09/2020
VALID
/
Chemistry
Telmisartan
JIANGSU ZHONGBANG PHARMACEUTICAL CO., LTD. CN 211 300 Gaochun
  R1-CEP 2013-085-Rev 00
09/03/2020
VALID
/
Chemistry
Telmisartan
ZHEJIANG TIANYU PHARMACEUTICAL CO., LTD. CN 318 020 Taizhou City
  R1-CEP 2014-190-Rev 00
05/08/2021
VALID
/
Chemistry
Telmisartan
SEQUEL PHARMACHEM PRIVATE LTD. IN 400 706 Nerul
  R0-CEP 2009-146-Rev 00
30/03/2011
EXPIRED
12/04/2016
Chemistry
Telmisartan
Ind-Swift Laboratories Limited IN 160 101 Chandigarh
  R0-CEP 2010-373-Rev 02
12/02/2016
WITHDRAWN BY HOLDER
19/06/2017
Chemistry
Telmisartan
MICRO LABS LIMITED IN 560 001 Bengaluru
  R0-CEP 2014-324-Rev 06
28/10/2019
WITHDRAWN BY HOLDER
12/08/2021
Chemistry
Telmisartan
Interquim, S.A. ES 08173 Sant Cugat Del Vallès
  R1-CEP 2010-363-Rev 00
04/02/2019
VALID
/
Chemistry
Telmisartan
MACLEODS PHARMACEUTICALS LIMITED IN 400 059 Mumbai
  R1-CEP 2011-072-Rev 00
22/05/2018
VALID
/
Chemistry
Telmisartan
Amino Chemicals LTD. MT MRS 3000 Marsa
  R0-CEP 2010-093-Rev 00
11/10/2012
WITHDRAWN BY HOLDER
19/05/2017
Chemistry
Telmisartan
CHROMO LABORATORIES INDIA PRIVATE LIMITED IN 502 307 Pashamylaram
  R0-CEP 2018-104-Rev 00
09/04/2021
VALID
/
Chemistry
Telmisartan
Moehs Iberica S.L. ES 08191 Rubi
  R1-CEP 2012-266-Rev 01
19/10/2020
VALID
/
Chemistry
Telmisartan
GLENMARK LIFE SCIENCES LIMITED IN 400 099 Mumbai
  R1-CEP 2009-028-Rev 03
18/11/2019
VALID
/
Chemistry
Telmisartan
Zhejiang Kinglyuan Pharmaceutical Co., Ltd. CN 312 369 Shangyu
  R0-CEP 2012-048-Rev 00
30/10/2014
EXPIRED
30/10/2019
Chemistry
Telmisartan
ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. CN 317 024 Linhai
  R1-CEP 2009-077-Rev 02
14/04/2021
VALID
/
Chemistry
Telmisartan
Glochem Industries Limited IN 500 018 Hyderabad
  R1-CEP 2010-271-Rev 00
04/11/2016
WITHDRAWN BY HOLDER
11/07/2019
Chemistry
Telmisartan
ALEMBIC PHARMACEUTICALS LIMITED IN 390 003 Vadodara
  R1-CEP 2008-217-Rev 06
02/05/2019
VALID
/
Chemistry
Telmisartan
MSN PHARMACHEM PRIVATE LIMITED IN 502 307 Pashamylaram Village
  R1-CEP 2009-108-Rev 03
12/04/2019
VALID
/
Chemistry
Telmisartan
AGC PHARMA CHEMICALS EUROPE S.L.U. ES 08380 Malgrat De Mar
  R1-CEP 2009-054-Rev 03
03/12/2019
VALID
/
Chemistry
Telmisartan
SUN PHARMACEUTICAL INDUSTRIES LIMITED IN 400 063 Mumbai
  R1-CEP 2009-229-Rev 01
24/09/2018
VALID
/
Chemistry
Telmisartan
JUBILANT GENERICS LIMITED IN 571 302 Nanjangud
  R1-CEP 2011-209-Rev 00
02/03/2018
VALID
/
Chemistry
Telmisartan
DIVI'S LABORATORIES LIMITED IN 500 032 Hyderabad
  R1-CEP 2012-302-Rev 00
01/04/2019
VALID
/
Chemistry
Telmisartan
CADILA HEALTHCARE LIMITED IN 393 002 Ankleshwar
  R1-CEP 2009-235-Rev 01
24/02/2021
VALID
/
Chemistry
Telmisartan
Unichem Laboratories Limited IN 400 102 Mumbai
  R0-CEP 2018-050-Rev 00
27/02/2019
VALID
/
Chemistry
TelmisartanKRKA d.d. SI 8501 Novo Mesto
  R0-CEP 2015-307-Rev 02
25/06/2020
VALID
/
Chemistry
Telmisartan
MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad
  R1-CEP 2008-256-Rev 01
08/04/2019
VALID
/
Chemistry
Telmisartan
TORRENT PHARMACEUTICALS LIMITED IN 382 428 Village Bhat
  R1-CEP 2011-256-Rev 02
18/09/2020
VALID
/
Chemistry
Telmisartan
HETERO LABS LIMITED IN 500 018 Hyderabad
  R0-CEP 2011-272-Rev 03
09/07/2019
WITHDRAWN BY HOLDER
30/07/2019
Chemistry
Telmisartan
AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad
  R1-CEP 2012-061-Rev 02
01/10/2020
VALID
/
Chemistry
Telmisartan Process-II
MICRO LABS LIMITED IN 560 001 Bengaluru
  R0-CEP 2020-388-Rev 00
15/03/2021
VALID
/
Chemistry



Producer:Jiangsu Zhongbang Pharmaceutical Co., Ltd., founded in 2001, is a wholly-owned subsidiary of China's top 500 enterprises - Red Sun Group. With a registered capital of 180 million yuan, the company now has four wholly-owned subsidiaries with more than 700 employees, covering a total area of more than 500 mu.

The company has perfect GMP management system, complete production facilities and equipment, advanced testing instruments and information system to ensure excellent and reliable product quality. The company has passed the GMP on-site inspection in China, South Korea, Japan and other countries, and many API have EU CEP certificate and China GMP certificate. The API workshop has two GMP certified production lines with an annual production capacity of 50 tons. The solid preparation workshop has equipment for making tablets, capsules and granules.

Staff size:100-199 persons
Registered capital:RMB 180 million


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:Topharman Shandong Co., Ltd.has passed the GMP inspection of China, the United States, the European Union and Japan. Tefaman has four production workshops and four independent clean areas with complete equipment and facilities, which can effectively control the chemical reaction from - 70 ℃ to 250 ℃.
Staff size:100-199 persons

Registered capital:RMB 10 million


Producer:Yichang HEC Changjiang Pharmaceutical Co., Ltd., formerly Yichang Changjiang Pharmaceutical Co., Ltd., was restructured into a joint stock limited company in 2015,

HEC pharmaceutical is the largest manufacturer of macrolide in the world and has passed the FDA certification; It is the largest Tamiflu production base in China; It is one of the enterprises with the highest level of producing insulin biological drugs; It is the most powerful enterprise in R & D, overseas registration and production of generic drugs in Europe, America and other developed countries; It is the first domestic pharmaceutical enterprise with independent research and development, independent registration and certification by FDA, EU and who.

Staff size:About 5000 persons

Registered capital:RM 45.202285 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 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:Chongqing Conquer Pharmaceutical Co., Ltd., founded in 1999, covers an area of 24000 square meters, with a plant construction area of nearly 10000 square meters, and has passed the new version of GMP certification in 2013. The company's existing product dosage forms are tablets and capsules, of which the tablet production capacity can reach 1 billion tablets and the capsule production capacity can reach 500 million tablets. At present, the company has 25 registration approvals for preparation products and 3 registration approvals for raw material production, forming a series of product groups such as hypoglycemic, antihypertensive, hypolipidemic, respiratory system, antibiotics, anti allergy and hepatobiliary drugs.
Staff size:200-299 persons

Registered capital:RMB 76.36181 million


Producer:Shandong Xinyi Pharmaceutical Co., Ltd. is a comprehensive pharmaceutical enterprise integrating manufacturing, sales and R & D, jointly funded by Shanghai Xinyi Pharmaceutical Factory Co., Ltd., a wholly-owned subsidiary of Shanghai Pharmaceutical Group Co., Ltd., Shandong Pingyuan pharmaceutical factory and Dezhou Borun Pharmaceutical Technology Co., Ltd.

Staff size:200-299 persons

Registered capital:RMB 17740.615851 million


Producer:Shandong Qidu Pharmaceutical Co., Ltd. is located in Linzi District, Zibo City, the former capital of the state of Qi, a famous historical and cultural city. There are more than 3800 employees, covering an area of more than 600 mu and a total asset of nearly 3 billion yuan.

Qidu Pharmaceutical Co., Ltd. is a comprehensive research-oriented pharmaceutical production enterprise focusing on injections with oral preparations and APIs. Its products mainly involve basic infusion, intravenous nutrition, plasma substitutes, anti infection, anti-tumor, cardio cerebrovascular, endocrine, pharmaceutical packaging materials and medical consumables, and has more than 170 drug production approval numbers.

The company has passed ISO9001 international quality management system certification, ISO14001 international environmental management system certification and national intellectual property management system certification.

Staff size:3000-3999 persons

Registered capital:RMB 90 million


Producer:Hunan Dino Pharmaceutical Co., Ltd., founded in 1997, formerly from Hunan Pharmaceutical Industry Research Institute, is a modern growth high-tech enterprise engaged in the production and marketing of medicine and raw materials.   At present, the company has two GMP certified modern pharmaceutical bases in Liuyang and Changsha, including more than ten dosage forms and 14 production lines, such as tablets, capsules, ointments, dry suspensions, pellets, small volume injections, chemical synthetic APIs and oral liquids. Strictly control "quality" and establish a quality assurance system in line with international quality supervision concepts such as FDA, ICH and EDQM.

Staff size:800-899 persons
Registered capital:RMB 17.876059 million


Producer:Beijing Shuanglu Pharmaceutical Co., Ltd. is the first high-tech enterprise in the capital to land on the SME Board of Shenzhen Stock Exchange. Since its establishment in 1994, relying on its technical advantages and continuous innovation, the company has researched, developed and put on the market more than 70 varieties of three national class I new drugs with independent intellectual property rights. The company has eight production bases, with a total area of 150000 square meters, The production capacity covers the high-tech fields involved in new pharmaceutical projects such as biological fermentation, biochemistry, traditional Chinese medicine extraction, chemical raw materials and antibodies, as well as oral solid preparations and production lines dedicated to water injection, powder injection, external medicine and anti-tumor in strict accordance with international GMP standards.
Staff size:About 800 persons

Registered capital:RMB 1 billion 27 million


Producer:Dongzhitang  Pharmaceutical (Anhui) Co., Ltd. is a pharmaceutical enterprise under Hong Kong Yuetong Co., Ltd. The company is located in the biomedical industrial park of Huainan Economic and Technological Development Zone, Anhui Province, covering an area of 50000 square meters and a construction area of 15000 square meters. Toshiba Tang Pharmaceutical (Anhui) Co., Ltd. has the following production lines: oral liquid preparations, oral solid preparations, decoction pieces of traditional Chinese medicine and chemical APIs. It can produce more than ten dosage forms and more than 100 varieties of traditional Chinese medicine pellets, concentrated traditional Chinese medicine pills, granules, tablets, capsules, oral liquids, syrups and plasters. All dosage forms have passed GMP certification.

Staff size:50-99 persons
Registered capital:RMB 18 million 233 thousand and 965


Producer:Changzhou Pharmaceutical Factory Co., Ltd. is a state-owned core enterprise of Shanghai Pharmaceutical. It is a comprehensive pharmaceutical enterprise with equal emphasis on chemical raw materials and chemical preparations and all-round development of science, industry and trade.

The company produces more than 30 kinds of APIs and more than 150 varieties of needles, tablets and capsules throughout the year. In 2016, the company's rosuvastatin calcium tablets passed the on-site inspection of Anda in the United States. In November 2007, the company passed the EU GMP certification. It has become the second enterprise in Jiangsu and the seventh enterprise in China that has passed the EU GMP certification. In 2012, it passed the EU GMP certification again.

Staff size:800-899 persons

Registered capital:RMB 108 million


Producer:Fuzhou Haiwang Fuyao Pharmaceutical Co., Ltd. is a holding subsidiary of Shenzhen Haiwang Group Co., Ltd. the company is located at No. 279, Zhongxia, Gushan Town, Jin'an District, Fuzhou, covering an area of 180000 square meters (2.7 hectares). Since 2000, the company has invested more than 100 million yuan in the transformation and large-scale construction of 17 dosage forms, 42 production lines and 9 production workshops, At present, all production lines of the company have passed the new national GMP certification. At the same time, the company is also in line with international standards and has passed ISO9001 quality management system and ISO14000 environmental management system certification at one time.  

The company has 6 infusion production lines of soft bags, plastic bottles and glass bottles, with an annual production capacity of 250 million bottles (bags)

Annual production of 2 billion tablets, 300 million capsules and 50 million packages of granules and powders; The hourly production capacity of small volume injections, anti-tumor, hormone and common preparations is more than 30000, with an annual output of more than 300 million; The annual production is 2 billion tablets, 300 million capsules and 50 million bags of granules and powders.

Staff size:600-699 persons

Registered capital:RMB 30 million


Producer:Changzhou Yabang Pharmaceutical Co., Ltd., established in October 2002, is located at No. 6, Liangchang East Road, Jintan Economic Development Zone, Changzhou City, Jiangsu Province, with a registered capital of 70 million yuan. Its business scope is the production and sales of chemical APIs. It is a subsidiary controlled by Jiangsu Yabang Pharmaceutical Group Co., Ltd.

The company covers an area of 80000 square meters, a construction area of 14000 square meters and a total investment of more than 100 million. It has 6 fine baking bag production lines, 5 synthesis workshops, 1 hydrogenation workshop, 1 testing center and 1 R & D center that meet the requirements of GMP, a set of sewage treatment devices and environmental protection facilities. The greening area is more than 40%, forming a professional company of 500 t / a API and pharmaceutical intermediates.

Staff size:200-299 persons   

Registered capital:RMB 70 million


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