Metformin
CAS number: 657-24-9
Molecular formula: C4H11N5
molecular weight: 129.16
Chemical structure:
Producers shown on SFDA
(Record date:30/08/2021)
Producer | Documents | GMP Valid till(based on SFDA) |
Shandong Keyuan Pharmaceutical Co., Ltd. | GMP | Valid till August 2022 |
Qufu Shengren Pharmaceutical Co., Ltd. | GMP | Valid till March 2022 |
Shijiazhuang Polee Pharmaceutical Co., Ltd. | GMP | Valid till June 2023 |
Shouguang Fukang Pharmaceutical Co., Ltd. | GMP | Valid till November 2021 |
Jiangsu Tohope Pharmaceutical Co., Ltd. | GMP | Valid till July 2023 |
Jilin Jinheng Pharmaceutical Co., Ltd. | GMP | Valid till April 2021 |
Tianjin Pacific Chemical & Pharmaceutical Co.,Ltd | GMP | Valid till December 2019 |
Jiangsu Hanstone Pharmaceutical Co., Ltd. | GMP | Valid till January 2021 |
Dandong Yichuang Pharmaceutical Co., Ltd. | GMP | Valid till June 2020 |
Producers shown on EP
(Quoted from EP website;record date:30/08/2021)
Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | End date |
Metformin Hydrochloride | HARMAN FINOCHEM LIMITED IN 400 098 Mumbai | R1-CEP 2000-059-Rev 11 | 26/03/2020 | VALID | / | Chemistry |
Metformin Hydrochloride Xylene process | SUN PHARMACEUTICAL INDUSTRIES LIMITED IN 400 063 Mumbai | R1-CEP 2011-122-Rev 00 | 05/10/2016 | VALID | / | Chemistry |
Metformin Hydrochloride | Coral Drugs Private Ltd IN 110 001 New Delhi | R0-CEP 2000-082-Rev 01 | 22/10/2004 | EXPIRED | 20/12/2007 | Chemistry |
Metformin Hydrochloride | AARTI DRUGS LIMITED IN 400 022 Mumbai | R0-CEP 2015-250-Rev 01 | 12/12/2018 | VALID | / | Chemistry |
Metformin Hydrochloride | Smruthi Organics Limited IN 413 255 Solapur | R1-CEP 2005-232-Rev 00 | 05/02/2013 | WITHDRAWN BY EDQM | 13/12/2013 | Chemistry |
Metformin Hydrochloride | SUN PHARMACEUTICAL INDUSTRIES LIMITED IN 400 063 Mumbai | R1-CEP 2001-374-Rev 03 | 28/07/2015 | WITHDRAWN BY HOLDER | 07/01/2020 | Chemistry |
Metformin Hydrochloride | AMRI INDIA PVT. LTD. IN 400 071 Mumbai | R1-CEP 2002-163-Rev 00 | 15/04/2009 | WITHDRAWN BY HOLDER | 21/03/2014 | Chemistry |
Metformin Hydrochloride Process I | USV PRIVATE LIMITED IN 400 088 MumbaiUSV PRIVATE LIMITED IN 400 088 Mumbai | R1-CEP 2012-096-Rev 01 | 15/05/2020 | VALID | / | Chemistry |
Metformin Hydrochloride | Merck Santé S.A.S. FR 69008 Lyon | R1-CEP 1997-029-Rev 05 | 18/10/2018 | VALID | / | Chemistry |
Metformin Hydrochloride | EXEMED PHARMACEUTICALS IN 391 440 Vadodara | R1-CEP 2011-328-Rev 02 | 18/11/2019 | VALID | / | Chemistry |
Metformin Hydrochloride | INDOCO REMEDIES LIMITED IN 400 098 Mumbai | R0-CEP 2007-188-Rev 01 | 30/10/2008 | WITHDRAWN BY HOLDER | 13/08/2012 | Chemistry |
Metformin Hydrochloride | Tapi Puerto Rico, Inc. PR 00784 Guayama | R1-CEP 1999-191-Rev 01 | 04/08/2008 | WITHDRAWN BY HOLDER | 06/03/2014 | Chemistry |
Metformin Hydrochloride | Aastrid International Private Limited IN 400 063 Mumbai | R1-CEP 2001-377-Rev 02 | 19/06/2014 | WITHDRAWN BY HOLDER | 17/03/2021 | Chemistry |
Metformin Hydrochloride | Aarti Drugs Limited IN 400 222 Mumbai | R0-CEP 2005-072-Rev 00 | 09/04/2009 | WITHDRAWN BY HOLDER | 06/03/2014 | Chemistry |
Metformin Hydrochloride | Uquifa Mexico S.A. de C.V. MX 62578 Jiutepec | R1-CEP 2003-063-Rev 03 | 29/10/2020 | VALID | / | Chemistry |
Metformin Hydrochloride | THINQ PHARMA-CRO LIMITED IN 400 604 Thane | R0-CEP 2017-310-Rev 00 | 05/04/2019 | VALID | / | Chemistry |
Metformin Hydrochloride | ABHILASH CHEMICALS AND PHARMACEUTICALS PRIVATE LIMITED IN 625 301 Madurai | R1-CEP 2006-312-Rev 02 | 31/07/2017 | VALID | / | Chemistry |
Metformin Hydrochloride | Farmhispania, S.A. ES 08160 Montmeló | R1-CEP 1999-183-Rev 04 | 18/02/2014 | VALID | / | Chemistry |
Metformin Hydrochloride | VISTIN PHARMA AS NO 3766 Sannidal | R1-CEP 1999-030-Rev 08 | 27/02/2019 | VALID | / | Chemistry |
Metformin Hydrochloride | IPCA Laboratories Limited IN 400 067 Mumbai | R1-CEP 2005-156-Rev 03 | 08/09/2017 | / | Chemistry | |
Metformin Hydrochloride | Auro Laboratories Limited IN 400 030 Mumbai | R1-CEP 2005-123-Rev 03 | 31/07/2017 | VALID | / | Chemistry |
Metformin Hydrochloride | USV PRIVATE LIMITED IN 400 088 Mumbai | R1-CEP 1997-049-Rev 08 | 07/07/2020 | VALID | / | Chemistry |
Metformin Hydrochloride | KORES (INDIA) LIMITED IN 400 705 Navi Mumbai | R1-CEP 2006-219-Rev 00 | 01/08/2013 | WITHDRAWN BY HOLDER | 06/02/2014 | Chemistry |
Metformin Hydrochloride | OLON S.P.A. IT 20053 Rodano | R1-CEP 2000-306-Rev 04 | 26/02/2014 | WITHDRAWN BY HOLDER | 07/01/2020 | Chemistry |
Metformin Hydrochloride | BLUE CIRCLE ORGANICS PRIVATE LIMITED IN 421 501 Ambernath West | R0-CEP 2013-149-Rev 01 | 06/10/2015 | EXPIRED | 15/07/2019 | Chemistry |
Metformin Hydrochloride | GRANULES INDIA LIMITED IN 500 081 Hyderabad | R1-CEP 2004-124-Rev 06 | 12/07/2021 | VALID | / | Chemistry |
Metformin Hydrochloride | AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad | R1-CEP 2004-088-Rev 07 | 02/03/2021 | VALID | / | Chemistry |
Metformin Hydrochloride | SINBIOTIK S.A. DE C.V. MX 54090 Tlalnepantla | R0-CEP 2019-060-Rev 00 | 25/11/2019 | VALID | / | Chemistry |
Metformin Hydrochloride Site-II | SUN PHARMACEUTICAL INDUSTRIES LIMITED IN 400 063 Mumbai | R0-CEP 2016-223-Rev 01 | 10/02/2021 | VALID | / | Chemistry |
Metformin Hydrochloride | IOL CHEMICALS AND PHARMACEUTICALS LTD IN 148 101 Fatehgarh Channa Village | R1-CEP 2013-188-Rev 00 | 21/04/2020 | VALID | / | Chemistry |
Metformin Hydrochloride BPL Site | GRANULES INDIA LIMITED IN 500 081 Hyderabad | R0-CEP 2018-120-Rev 00 | 08/11/2018 | VALID | / | Chemistry |
Metformin Hydrochloride | SOHAN HEALTHCARE PVT. LTD. IN 413 802 Kurkumbh | R1-CEP 2009-233-Rev 01 | 16/12/2020 | VALID | / | Chemistry |
Metformin Hydrochloride Micronised, non-micronised | SHOUGUANG FUKANG PHARMACEUTICAL CO., LTD. CN 262 700 Shouguang City | R1-CEP 2008-043-Rev 06 | 13/01/2021 | VALID | / | Chemistry |
Metformin Hydrochloride | SHANDONG SHOUGUANG BOKANG PHARMACEUTICAL CO., LTD. CN 262 714 Yangkou Town | R0-CEP 2019-141-Rev 00 | 22/03/2021 | VALID | / | Chemistry |
Metformin Hydrochloride | LAURUS LABS LIMITED IN 500 034 Hyderabad | R0-CEP 2016-319-Rev 02 | 30/07/2021 | VALID | / | Chemistry |
Metformin Hydrochloride | Wanbury Limited IN 400 703 Vashi, Navi Mumbai | R1-CEP 1998-079-Rev 10 | 10/08/2021 | VALID | / | Chemistry |
Producer:Shandong Keyuan Pharmaceutical Co., Ltd. is a national high-tech enterprise, a core member enterprise of Linuo group's health industry and a backbone enterprise of chemical synthetic drugs in Shandong Province. It is committed to the R & D, production and sales of chemical API products and the development of China's pharmaceutical industry
The development of international high-end CMO / cdmo business has established strategic partnership with many well-known international enterprises.
In February 2016, Keyuan pharmaceutical was successfully listed in the National SME share transfer system,
At present, the company has obtained the domestic GMP certificate and the EU CEP certificate with international top certification, and has passed the international official certification of the United States FDA, Canada, Japan, South Korea and so on. The company has a relatively perfect production and R & D system. The production plant is located in the development zone of Shanghe County, Jinan, covering an area of more than 200 acres
Staff size:About 400 persons
Registered capital:RMB 58 million
Producer:Qufu Shengren Pharmaceutical Co., Ltd. is a national GMP certified enterprise and the first enterprise in Shandong Province to obtain the production license of medicinal Stevia.
With a registered capital of 19.68 million yuan, the company is located in Shengwang international science and Technology Park, Shuyuan economic development zone. It covers an area of 18000 square meters and has more than 200 employees. The company has been committed to the research and production of APIs, food additives, various pharmaceutical raw materials and intermediates extracted from natural plants for many years. Its main products include stevia The raw materials are metformin hydrochloride, stevioside, rebaudioside A399-A340, etc. the products sell well in 18 provinces, cities and autonomous regions in China and international markets such as Japan, South Korea, the United States and Canada, enjoying a good reputation.
In recent years, the company has invested more than 30 million yuan to build two Stevia production lines. Stevioside (glycoside) can achieve an annual output of 500t. High content RA products also have an annual output of 500t, and now all have reached the production capacity.
The company's products fully adopt GMP standards and establish a quality assurance system in line with GMP standards. At the same time, the company has world-class testing instruments and equipment and GMP standard testing and testing center, and has strong technical strength and scientific research platforms such as provincial enterprise technology center and postdoctoral workstation.
Producer:Founded in 2006, Shijiazhuang Polee Pharmaceutical Co., Ltd. is a comprehensive modern manufacturer of APIs, pharmaceutical excipients and pharmaceutical intermediates integrating production, R & D and sales. The main products are cimetidine (type A / AB) and metformin hydrochloride; Pharmaceutical excipients: aspartame, magnesium aluminum silicate; Pharmaceutical intermediate cimetidine dichret, dimethylamine hydrochloride. The factory covers an area of 34000 square meters and has a registered capital of 21 million yuan. The company is located in xinzhaidian Industrial Zone, Zhao county, Shijiazhuang City, 650m away from national highway 308, 28km away from Shijiazhuang city and 4km away from xinzhaidian exit of Qingyin expressway. The transportation is very convenient.
the company is designed and constructed according to GMP requirements. The plant layout is reasonable, the environment is beautiful, the production workshop equipment is advanced, and the company is equipped with advanced inspection instruments, which can meet the production needs. The company pays attention to product quality, organizes production and quality management in strict accordance with the requirements of GMP, and the product quality is stable. Both cimetidine and metformin hydrochloride have passed the new GMP certification. Cimetidine was registered in Taiwan and India in 2011. Metformin hydrochloride was registered in India in 2016 and in Taiwan in 2017.
Producer:Founded in 1993, Shouguang Fukang is a premier research and technology driven Chinese pharmaceutical enterprise with demonstrated capabilities for new drug research and development. It is ranked 42nd among China's Pharmaceutical Industry, employs 3,000 people and has a manufacturing campus of over 300 acres (2,000 Chinese acre).
Shouguang Fukang Pharmaceutical Co., Ltd. specializes in the development, manufacturing and marketing of 5 core product categories. They are PHARMACEUTCAL API, INTERMEDITES and FINISHED DOSE as well as BROMIDE COMPOUNDS and PAPER ADDITIVES, with a total of more than 60 products. Our production and sales volume of the API, trimethoprim (TMP), accounts for more than 70% of the world market. We are the No. 1 domestic producer and marketer of omeprazole, sulfamethoxazole (SMZ) and metformin HCl and the largest production base of bromide compounds. In a joint venture with BASF, we produce the following paper additives ; ODB-II, ODB-I, S-205 and EGTE, to the highest international standards.
Shouguang Fukang has established and implemented comprehensive quality assurance and quality control systems, with certifications of ISO9001/14001 and OHSAS18001. Shouguang Fukang was one of the first companies to receive SFDA GMP certification and five of our APIs, TMP, SMZ, omeprazole, metformin HCl and clozapine, have successfully passed USFDA inspection in Year 2011. We also gained COS certification from the European Directorate for the Quality of Medicines (EDQM). In addition we have successfully passed quality site audits from numerous renowned multinational corporations. Our company's products are domestically sold in 26 provinces and are exported to over 60 countries worldwide.
Registered capital:USD 156 million
Producer:
The company covers a total area of 210 mu (including 60 mu of new preparation factory), with a construction area of 26000 m2. It has shady trees, lawns and beautiful environment, presenting a strong atmosphere of garden factory. There are more than 300 employees, including more than 80 professional and technical personnel.
It passed ISO9001 quality management system certification in 2001, ERP information management in 2002, ISO14001 international environmental protection system certification and GB / T28001 (OHSAS18001) occupational health and safety management system certification in 2005, drug GMP certification in the same year and health food GMP certification in 2006.
Staff size:100-199 persons
Registered capital:RMB 120 million
Producer:Jilin Jinheng Pharmaceutical Co., Ltd., established in April 2003, is a large comprehensive pharmaceutical group integrating API, bioengineering pharmacy, western medicine, Chinese patent medicine, health products and pharmaceutical intermediates.
Jilin Hengjin Pharmaceutical Co., Ltd. is a key high-tech enterprise recognized by the state, with independent import and export management rights. At present, there are 343 kinds of preparation products and 23 varieties of synthetic drugs. It has many modern production lines such as solid preparations, oral liquid, powder injection, water injection and chemical API, all of which have passed the national GMP certification.
Registered capital:RMB 16.25 million
Producer:Tianjin Pacific Chemical Pharmaceutical Co., Ltd. was founded in 2001. It is located in the development zone of Jinnan District, Tianjin. It covers an area of more than 39000 square meters. The building area is 9259.55 square meters.
The company now produces and operates a variety of API varieties, equipped with advanced production equipment and testing instruments, and high-quality personnel are engaged in scientific research, development, technology and sales. So as to achieve strict scientific management of production and quality and good after-sales service. Take GMP as the standard, follow the company philosophy and purpose of "more scientific, more rigorous and more standardized - responsible for life", strictly manage and ensure quality. Continuously improve the competitiveness of fist products and strive to make greater development in all work of the enterprise.
Staff size:200-299 persons
Registered capital:RMB 36million 9 hundred and 95 thousand 9 hundred
Producer:Jiangsu Hanstone Pharmaceutical Co., Ltd. is a modern API pharmaceutical enterprise completed and put into operation in 2005, and has become a high-tech enterprise in Jiangsu Province.
The two plant areas of the company cover an area of about 70 mu, and the investment in the new plant area is more than 60 million yuan. It mainly produces and operates chemical synthetic APIs and sterile APIs. According to the latest relevant national laws and regulations, the workshop shall be constructed according to GMP standards. Since its establishment, it has experienced more than ten domestic and international GMP certification of API. At the end of 2013, all sterile APIs of the company passed the GMP certification of 2010 version, and at the end of 2015, all non sterile APIs of the company passed the GMP certification of 2010 version, laying a good foundation for the next development of the company. The main product ranitidine hydrochloride quality and sales volume in China. It was registered by Japan DMF in November 2006 and became a qualified foreign manufacturer of Japanese API. After receiving the strict inspection of the Japanese government, the company successfully passed the GMP inspection of PMDA of Japan's Ministry of health, labor and welfare, marking that ranitidine hydrochloride of our company has become a product successfully exported to the Japanese market, paving the way for large-scale sales in the Japanese market.
Staff size:50-99 persons
Registered capital:RMB 20.36 million
Producer:The predecessor of Dandong Yichuang Pharmaceutical Co., Ltd. is the former Dandong pharmaceutical factory. The former Dandong pharmaceutical factory was founded in 1954 and is a large state-owned enterprise. Dandong Yichuang Pharmaceutical Co., Ltd. is a joint-stock company transformed on this basis in December 2003. The registered capital of the company is 7.14 million yuan and has total assets of 460 million yuan. The new plant is located in the Binhai west area of Donggang Economic Development Zone, covering an area of 131 mu with a total investment of nearly 240 million yuan. As of June 2015, it has completed the new national GMP certification of small volume injection, solid oral preparation and synthetic API workshop and obtained the certificate. The company's main product dosage forms officially reached production in 2015. The new plant has formed a production capacity of 240 tons of chemical APIs, 3 billion tablets, 50 million freeze-dried powder injections and 50 million water injections.
Registered capital:RMB 7 million 142 thousand and 857
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