
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Telmisartan | WATSON PHARMA PRIVATE LIMITED IN 400 059 Mumbai | R0-CEP 2010-261-Rev 00 | 22/01/2013 | WITHDRAWN BY EDQM | 13/12/2013 | Chemistry |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Telmisartan | GRANULES INDIA LIMITED IN 500 081 Hyderabad | R0-CEP 2011-355-Rev 01 | 29/01/2015 | WITHDRAWN BY HOLDER | 03/01/2018 | Chemistry |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 |
Telmisartan | KRKA 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.
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
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