Potassium Clavulanate
CAS number： 61177-45-5
Molecular formula： C8H8KNO5
molecular weight： 237.251
Chemical structure：
Producers shown on SFDA
(Record date:27/08/2021）
Producer | Documents | GMP Valid till(based on SFDA) |
Shandong New Time Pharmaceutical Co., Ltd. | GMP, DMF | Valid till July 2023 |
Zhuhai United Laboratories Co., Ltd. | GMP | Valid till March 2023 |
Sinopharm Weiqida Pharmaceutical Co.,Ltd. | GMP | Valid till January 2024 |
United Laboratories (Inner Mongolia) Co., Ltd. | GMP | Valid till September 2023 |
Sichuan Renan Pharmaceutical Co., Ltd. | GMP | Valid till September 2022 |
Producers shown on EP
(Quoted from EP website；record date:27/08/2021）
| Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | Type |
| Potassium clavulanate | DSM Anti-Infectives B.V. NL 2613 AX Delft | R1-CEP 1997-087-Rev 04 | 12/01/2010 | WITHDRAWN BY HOLDER | 11/02/2016 | Chemistry |
| Potassium clavulanate, diluted with silicon dioxide in the ratio 1:1 | CIPAN - COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS, S.A. PT 2600-726 Castanheira Do Ribatejo | R0-CEP 2008-146-Rev 00 | 05/08/2010 | EXPIRED | / | Chemistry |
| Potassium clavulanate, diluted with microcrystalline Cellulose in the ratio 7:3 | Fermic SA de CV MX 09850 Iztapalapa | R1-CEP 2009-358-Rev 00 | R1-CEP 2009-358-Rev 00 | VALID | / | Chemistry |
| Potassium clavulanate, diluted with microcrystalline cellulose in a ratio of 3:2 | Sandoz Industrial Products SpA IT 38068 Rovereto | R0-CEP 2004-234-Rev 01 | 13/10/2009 | EXPIRED | 24/03/2011 | Chemistry |
| Potassium clavulanate, diluted with microcrystalline cellulose in the ratio 1:1 | Fermic SA de CV MX 09850 Iztapalapa | R1-CEP 2006-021-Rev 02 | 03/02/2015 | VALID | / | Chemistry |
| Potassium clavulanate, diluted with microcrystalline cellulose in the ratio 1:1 | CKD BIO CORPORATION KR 15604 Ansan-si | R1-CEP 2005-179-Rev 03 | 09/02/2017 | VALID | / | Chemistry |
| Potassium clavulanate, diluted Microcrystalline cellulose 1:1 blend | Smithkline Beecham Pharmaceuticals GB KA11 5AP Irvine | R1-CEP 2005-244-Rev 01 | 01/12/2017 | VALID | / | Chemistry |
| Potassium clavulanate, diluted with microcrystalline cellulose in a ratio 1:1 | DSM Anti-Infectives B.V. NL 2613 AX Delft | R1-CEP 2002-235-Rev 01 | 12/01/2010 | WITHDRAWN BY HOLDER | 11/02/2016 | Chemistry |
| Potassium clavulanate | Fermic SA de CV MX 09850 Iztapalapa | R1-CEP 2000-404-Rev 03 | 02/09/2013 | VALID | / | Chemistry |
| Potassium clavulanate | SHANDONG NEW TIME PHARMACEUTICAL CO., LTD. CN 273 400 Linyi | R1-CEP 2011-374-Rev 00 | 15/12/2017 | VALID | / | Chemistry |
| Potassium clavulanate | CIPAN - COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS, S.A. PT 2600-726 Castanheira Do Ribatejo | R0-CEP 2008-147-Rev 00 | 05/08/2010 | EXPIRED | 05/08/2015 | Chemistry |
| Potassium clavulanate, diluted with microcrystalline cellulose in the ratio 1:1 | CIPAN - COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS, S.A. PT 2600-726 Castanheira Do Ribatejo | R0-CEP 2008-148-Rev 00 | 05/08/2010 | EXPIRED | 05/08/2015 | Chemistry |
| Potassium clavulanaAte | Smithkline Beecham Pharmaceuticals GB KA11 5AP Irvine | R1-CEP 1999-111-Rev 03 | 03/08/2018 | VALID | / | Chemistry |
| Potassium clavulanate, diluted with microcrystalline cellulose in the ratio 7:3 | CKD BIO CORPORATION KR 15604 Ansan-si | R1-CEP 2005-178-Rev 02 | 20/01/2017 | VALID | / | Chemistry |
| Potassium clavulanate | CKD BIO CORPORATION KR 15604 Ansan-si | R1-CEP 2003-183-Rev 04 | 26/01/2017 | VALID | / | Chemistry |
| Potassium clavulanate, diluted with silica, colloidal hydrated in the ratio 1:1 | CKD BIO CORPORATION KR 15604 Ansan-si | R1-CEP 2005-180-Rev 03 | 18/01/2017 | VALID | / | Chemistry |
| Potassium clavulanate, diluted with silicon dioxide in the ratio 1:1 | Deva Holding A.Ş. TR 34303 Istanbul | R1-CEP 2012-391-Rev 00 | 05/11/2018 | VALID | / | Chemistry |
| Potassium clavulanate, diluted silica, colloidal hydrated in a ratio 1:1 | Smithkline Beecham Pharmaceuticals GB KA11 5AP Irvine | R0-CEP 2006-068-Rev 01 | 02/02/2010 | WITHDRAWN BY HOLDER | / | Chemistry |
| Potassium clavulanate, diluted with silica, colloidal hydrated in a ratio of 1:1 | DSM Anti-Infectives B.V. NL 2613 AX Delft | R1-CEP 2002-256-Rev 01 | 12/01/2010 | WITHDRAWN BY HOLDER | 11/02/2016 | Chemistry |
| Potassium clavulanate | LEK PHARMACEUTICALS D.D. SI 1526 Ljubljana | R1-CEP 2003-262-Rev 03 | 17/06/2020 | VALID | / | Chemistry |
| Potassium clavulanate | ZHUHAI UNITED LABORATORIES CO., LTD. CN 519 040 Sanzao Town | R0-CEP 2015-083-Rev 01 | 26/04/2017 | VALID | / | Chemistry |
| Potassium clavulanate Sterile | ZHUHAI UNITED LABORATORIES CO., LTD. CN 519 040 Sanzao Town | R1-CEP 2013-133-Rev 01 | 02/12/2019 | VALID | / | Chemistry |
| Potassium clavulanate | Deva Holding A.Ş. TR 34303 Istanbul | R1-CEP 1998-129-Rev 08 | 18/10/2017 | VALID | / | Chemistry |
| Potassium clavulanate, diluted With microcrystalline cellulose in the ratio 1:1 | ZHUHAI UNITED LABORATORIES CO., LTD. CN 519 040 Sanzao Town | R1-CEP 2013-163-Rev 00 | 12/11/2019 | VALID | / | Chemistry |
| Potassium clavulanate, diluted with microcrystalline cellulose in the ratio 1:1 | Deva Holding A.Ş. TR 34303 Istanbul | R1-CEP 2012-392-Rev 00 | 05/11/2018 | VALID | / | Chemistry |
| Potassium clavulanate Sterile | Smithkline Beecham Pharmaceuticals GB BN14 8QH Worthing | R1-CEP 1999-113-Rev 04 | 26/02/2014 | VALID | / | Chemistry |
| Potassium clavulanate, diluted with microcrystalline cellulose in the ratio 1:1 | LEK PHARMACEUTICALS D.D. SI 1526 Ljubljana | R1-CEP 2007-259-Rev 02 | 05/03/2021 | VALID | / | Chemistry |
| Potassium clavulanate, diluted with silica, colloidal anhydrous in a ratio of 1:1 | Fermic SA de CV MX 09850 Iztapalapa | R1-CEP 2006-018-Rev 02 | 08/12/2014 | VALID | / | Chemistry |
| Potassium clavulanate, diluted with microcrystalline cellulose in the ratio 7:3 | LEK PHARMACEUTICALS D.D. SI 1526 Ljubljana | R1-CEP 2007-258-Rev 02 | 05/03/2021 | VALID | / | Chemistry |
| Potassium clavulanate, diluted with silica, colloidal hydrated in the ratio 1:1 | LEK PHARMACEUTICALS D.D. SI 1526 Ljubljana | R1-CEP 2004-241-Rev 03 | 07/02/2020 | VALID | / | Chemistry |
| Potassium clavulanate, diluted with microcrystalline cellulose in a ratio of 1:1 | LEK PHARMACEUTICALS D.D. SI 1526 Ljubljana | R1-CEP 2004-242-Rev 03 | 07/02/2020 | VALID | / | Chemistry |
| Potassium clavulanate, diluted with silica, colloidal anhydrous (0434) in ratio 1:1 | SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD CN 037 300 Datong | R1-CEP 2014-329-Rev 00 | 03/03/2021 | VALID | / | Chemistry |
| Potassium clavulanate, diluted with cellulose microcrystalline (0316) in ratio 1:1 | SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD CN 037 300 Datong | R1-CEP 2014-327-Rev 00 | 05/03/2021 | VALID | / | Chemistry |
| Potassium clavulanate, diluted with silica, colloidal hydrated in the ratio 1:1 | LEK PHARMACEUTICALS D.D. SI 1526 Ljubljana | R1-CEP 2007-260-Rev 02 | 08/03/2021 | VALID | / | Chemistry |
| Potassium clavulanate Sterile | Sandoz Industrial Products S.A. ES 08520 Les Franqueses Del Vallès | R1-CEP 1998-142-Rev 09 | 10/03/2021 | VALID | / | Chemistry |
| Potassium clavulanate Code Number 472803 | LEK PHARMACEUTICALS D.D. SI 1526 Ljubljana | R1-CEP 1998-001-Rev 09 | 25/02/2020 | VALID | / | Chemistry |
| Potassium clavulanate | SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD CN 037 300 Datong | R1-CEP 2014-320-Rev 00 | 05/03/2021 | VALID | / | Chemistry |
| Potassium clavulanate, diluted With microcrystalline cellulose in the ratio 1:1 | SHANDONG NEW TIME PHARMACEUTICAL CO., LTD. CN 273 400 Linyi | R1-CEP 2011-375-Rev 02 | 08/04/2021 | VALID | / | Chemistry |
| Potassium clavulanate, diluted With silicone dioxide in the ratio 1:1 | ZHUHAI UNITED LABORATORIES CO., LTD. CN 519 040 Sanzao Town | R1-CEP 2013-187-Rev 00 | 13/11/2019 | VALID | / | Chemistry |
| Potassium clavulanate, diluted With silicone dioxide in the ratio 1:1 | SHANDONG NEW TIME PHARMACEUTICAL CO., LTD. CN 273 400 Linyi | R1-CEP 2011-376-Rev 02 | 01/03/2021 | VALID | / | Chemistry |
Producer:Shandong New Time Pharmaceutical Co., Ltd. is a member enterprise of Lunan Pharmaceutical Group. It is a national key high-tech enterprise. It was founded on March 23, 2002. It has more than 4000 employees. The overall planning covers an area of 8600 Mu and the planned investment is 10 billion yuan. It is mainly engaged in the R & D and production of traditional Chinese medicine, western medicine, chemical raw materials, preparations, antibiotics, biopharmaceutical and genetic engineering.
The enterprise has established a quality assurance system in line with international quality supervision concepts such as ICH, FDA and EDQM. All dosage forms and varieties have passed the new national GMP certification and won the title of "the best industrial enterprise in China's pharmaceutical R & D product line" for many times. The overall quality management level ranks in the forefront of the same industry in the country.
Staff size:4000-4990 persons
Registered capital:RMB 363.908 million
Producer:Zhuhai United Laboratories Co., Ltd. is a subsidiary of The United Laboratories International Holdings Limited (United Lab). United Lab now has 11 major series of preparation products, more than 60 varieties, more than 120 product specifications, and nearly 50 varieties of 5 major series of API and intermediate products. All workshops of UL have passed the new version of GMP certification in China, and many products have successively obtained EU GMP certification and US FDA certification. With advanced enzymatic production technology, UL has become the first enterprise in China to obtain the EU CEP certificate of enzymatic amoxicillin, and a number of scientific and technological achievements have obtained national patents.
United Labowns advanced production equipment and adequate production capacity. Every year, it can produce 1.8 billion capsules, 1 billion tablets, 134 million sachets of granules, 86 million sachets of suspension, 20 million vials of oral solution, 117 million vials of powder injections, 37.8 million tubes of ointments, 28 million vials of lyophilized powder for injection, 24 million tubes of eye drops and about 300 million tubes of insulin preparation.
Staff size:2000-2999 persons
Registered capital:RMB 1 billion 678 million 396 thousand
Producer:Sinopharm Weiqida Pharmaceutical Co.,Ltd.is a wholly-owned subsidiary of Shanghai Modern Pharmaceutical Co., Ltd. the company is located in the pharmaceutical industrial park of Datong Economic and Technological Development Zone, Shanxi Province. Its holding Sinopharm group Datong Weiqida Zhongkang Pharmaceutical Co., Ltd. covers a total area of 1314 Mu and has 4310 employees.
Wichita and Wichita Zhongkang have the production capacity of three mother nuclei of 7aca, 6apa and 7adca antibiotics, and form a complete industrial chain of cephalosporins and penicillins from basic raw materials to terminal preparations. Their products are highly competitive in domestic and foreign markets. All production workshops of the company have passed the new national GMP certification, and the production workshops of core products are designed and constructed in accordance with the standards of FDA and CEP of the European Union. The company has set up product R & D centers and joint laboratories in Shanghai, Guangzhou and the headquarters, formed a trinity scientific and technological R & D system, and has a scientific and technological R & D team with high quality and strong professional ability.
Staff size:About 4300 persons
Registered capital:RMB 112 million
Producer:United Laboratories (Inner Mongolia) Co., Ltd. is a modern comprehensive pharmaceutical enterprise integrating medicine, chemical intermediates and human (Veterinary) APIs. The company was founded in April 2007, covering a total area of nearly 3000 mu, with more than 5400 employees and a total investment of nearly 9 billion yuan. The main products include: 6-APA, amoxicillin API, penicillin G potassium, clavulanate potassium, etc.
The company fully implements GMP, adheres to the quality management policy of "scientific management, strict monitoring, high quality and efficiency and customer satisfaction", and improves the drug production quality with the integrity and technology of the enterprise. In 2015, it passed the certification of quality system (ISO9001), environmental system (ISO14001) and occupational health and safety management system (ISO18001). The company's products sell well in more than 60 countries and regions such as Europe, Africa, South America, Southeast Asia, India, Iran, the United States, the Middle East and Pakistan. Among them, 6-APA has passed FDA certification; Amoxicillin API has passed the certification of EU, India, Mexico and South Korea.
Staff size:5000-5999 persons
Registered capital:RMB 2920 million
Producer:Sichuan Renan Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Chengdu Beite Pharmaceutical Co., Ltd., was established in August 2013. It is a high-tech enterprise dedicated to the R & D, production and sales of high-end APIs and intermediates.
At present, Sichuan ren'an Pharmaceutical Co., Ltd. has two production bases, which are located in Yuechi County, Guang'an City, Sichuan Province and Qingbaijiang District, Chengdu City. Its headquarters is set up in Yuechi production base. Yuechi production base covers an area of 325 mu, with a construction area of 55636.83 square meters. It has 9 GMP production workshops, 1 pilot workshop and more than 700 employees. It mainly produces penicillin sterile API, cephalosporin non sterile API, ordinary non sterile API (including ephedrine), precursor API, etc., and has 55 API production approvals, Among them, 18 varieties have passed the national GMP certification and achieved industrial production, and the sterile API "ampicillin sodium" has passed the two international GMP certification of EU and Japan. Qingbaijiang production base covers an area of 30 mu and a construction area of 6100 square meters. It has two GMP production workshops, mainly producing ordinary non sterile API.
Staff size:700-799 persons
Registered capital:RMB 180 million
For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +86 18402846978
Tel: Cell/WhatsApp/WeChat: +86 18402846978
Email: paulzhang@yinuopharmchem.com
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