Amoxicillin
CAS number： 26787-78-0
Molecular formula： C16H19N3O5S·3H2O
molecular weight： 419.46
Chemical structure：
Producers shown on SFDA
(Record date:09/09/2021）
Producer | Documents | GMP Valid till(based on SFDA) |
Sinopharm Weiqida Pharmaceutical Co.,Ltd. | GMP | Valid till January 2026 |
Hebei Expedition YACCA Pharmaceutical Co., Ltd. | GMP | Valid till November 2025 |
United Laboratories (Inner Mongolia) Co., Ltd. | GMP | Valid till June 2023 |
Producers shown on EP
(Quoted from EP website；record date:25/08/2021）
| Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | Type |
| Amoxicillin trihydrate Powder, compacted and micronised powder | KDL Biotech Limited IN 400 018 Mumbai | R0-CEP 1997-129-Rev 00 | 24/01/2005 | WITHDRAWN BY EDQM | 11/03/2011 | Chemistry |
| Amoxicillin sodium Sterile, Process Y | Amifarma S.L. ES 08389 Palafolls (Barcelona) | R1-CEP 1998-002-Rev 00 | 09/09/2003 | WITHDRAWN BY HOLDER | 30/05/2005 | Chemistry |
| Amoxicillin trihydrate | SUN PHARMACEUTICAL INDUSTRIES LIMITED IN 400 063 Mumbai | R1-CEP 1997-028-Rev 04 | 29/05/2015 | WITHDRAWN BY HOLDER | 12/07/2021 | Chemistry |
| Amoxicillin trihydrate Mexico, Powder material, Compacted Grade A, Compacted for Direct Compression | Fersinsa GB S.A. De C.V. MX 25900 Ramos Arizpe | R2-CEP 1995-030-Rev 02 | 02/06/2014 | VALID | / | Chemistry |
| Amoxicillin trihydrate | SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD. CN 037 304 Datong | R0-CEP 2019-244-Rev 00 | 23/07/2020 | VALID | / | Chemistry |
| Amoxicillin sodium | FRESENIUS KABI IPSUM S.R.L. IT 20051 Cassina de’ Pecchi | R1-CEP 2008-267-Rev 06 | 09/07/2021 | VALID | / | Chemistry |
| Amoxicillin sodium Sterile | ACS DOBFAR S.P.A. IT 20067 Tribiano | R1-CEP 1998-069-Rev 01 | 17/06/2009 | VALID | / | Chemistry |
| Amoxicillin trihydrate India, Process O | DSM Anti-Infectives B.V. NL 2613 AX Delft | R2-CEP 1995-014-Rev 01 | 21/02/2006 | WITHDRAWN BY HOLDER | 23/05/2011 | Chemistry |
| Amoxicillin trihydrate Compacted | North China Pharmaceutical Group Semisyntech Co., Ltd. CN 052 165 Shijiazhuang | R1-CEP 2009-329-Rev 00 | 17/03/2015 | WITHDRAWN BY HOLDER | 28/05/2019 | Chemistry |
| Amoxicillin trihydrate | AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad | R1-CEP 2007-147-Rev 03 | 03/10/2017 | VALID | Chemistry | |
| Amoxicillin trihydrate | PARABOLIC DRUGS LIMITED IN 134 109 Panchkula District | R1-CEP 2004-266-Rev 01 | 16/11/2012 | WITHDRAWN BY EDQM | 29/07/2015 | Chemistry |
| Amoxicillin trihydrate Enzymatic process | GlaxoSmithKline Research & Development Limited GB TW8 9GS London | R1-CEP 2015-064-Rev 00 | 03/03/2021 | VALID | Chemistry | |
| Amoxicillin trihydrate For veterinary purposes only, sterile | SANDOZ GMBH AT 6250 Kundl | R0-CEP 2007-018-Rev 02 | 28/05/2013 | WITHDRAWN BY HOLDER | 08/09/2014 | Chemistry |
| Amoxicillin trihydrate | Oman Chemicals And Pharmaceuticals L.L.C. OM 512 Al Buraimi | R1-CEP 1996-060-Rev 03 | 20/12/2010 | WITHDRAWN BY EDQM | 08/04/2021 | Chemistry |
| Amoxicillin trihydrate India, Process 1 | DSM Anti-Infectives India LIMITED IN 144 533 Toansa | R1-CEP 2001-351-Rev 01 | 23/01/2008 | WITHDRAWN BY HOLDER | 23/05/2011 | Chemistry |
| Amoxicillin trihydrate | ANTIBIÓTICOS DE LEÓN S.L.U ES 24009 León | R1-CEP 2001-123-Rev 03 | 16/02/2015 | VALID | / | Chemistry |
| Amoxicillin trihydrate | North China Pharmaceutical Group Semisyntech Co., Ltd. CN 052 165 Shijiazhuang | R1-CEP 2004-074-Rev 00 | 30/04/2013 | WITHDRAWN BY HOLDER | 28/05/2019 | Chemistry |
| Amoxicillin trihydrate Egypt | DSM Anti-Infectives B.V. NL 2613 AX Delft | R2-CEP 1994-013-Rev 03 | 03/07/2009 | WITHDRAWN BY HOLDER | 10/01/2018 | Chemistry |
| Amoxicillin trihydrate | Teva Pharmaceutical Industries Ltd. IL 49131 Petach Tikva | R1-CEP 2004-146-Rev 01 | 01/08/2013 | VALID | / | Chemistry |
| Amoxicillin sodium Sterile | Istituto Biochimico Italiano "G. Lorenzini" S.p.A. IT 04011 Aprilia | R1-CEP 1996-013-Rev 07 | 12/01/2018 | VALID | / | Chemistry |
| Amoxicillin trihydrate Micronised, normal and high density powder | ZHUHAI UNITED LABORATORIES CO., LTD. CN 519 040 Sanzao Town | R1-CEP 2006-039-Rev 02 | 16/10/2020 | VALID | / | Chemistry |
| Amoxicillin trihydrate Material codes 472191, 472188, 472205, 451787, 440017, 440029, 452360 | Sandoz Industrial Products S.A. ES 08520 Les Franqueses Del Vallès | R2-CEP 1995-034-Rev 06 | 12/11/2015 | VALID | / | Chemistry |
| Amoxicillin trihydrate | INNER MONGOLIA CHANGSHENG PHARMACEUTICAL CO., LTD. CN 010 206 Tuoketuo | R1-CEP 2007-315-Rev 02 | 31/01/2020 | VALID | / | Chemistry |
| Amoxicillin trihydrate Almería, Spain | CENTRIENT PHARMACEUTICALS NETHERLANDS B.V. NL 2613 AX Delft | R1-CEP 2001-367-Rev 05 | 21/03/2019 | VALID | / | Chemistry |
| Amoxicillin sodium Sterile | SANDOZ GMBH AT 6250 Kundl | R1-CEP 1998-058-Rev 06 | 18/10/2013 | VALID | / | Chemistry |
| Amoxicillin sodium Sterile | AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad | R1-CEP 2008-002-Rev 01 | 02/06/2017 | VALID | / | Chemistry |
| Amoxicillin trihydrate Enzymatic process | AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad | R0-CEP 2017-037-Rev 01 | 16/04/2019 | VALID | / | Chemistry |
| Amoxicillin trihydrate | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. CN 050 041 Shijiazhuang City | R1-CEP 2004-147-Rev 00 | 22/04/2013 | WITHDRAWN BY HOLDER | 16/09/2019 | Chemistry |
| Amoxicillin sodium Sterile | ZHUHAI UNITED LABORATORIES CO., LTD. CN 519 040 Sanzao Town | R1-CEP 2013-125-Rev 01 | 06/11/2020 | VALID | / | Chemistry |
| Amoxicillin trihydrate Toansa, India | CENTRIENT PHARMACEUTICALS NETHERLANDS B.V. NL 2613 AX Delft | R1-CEP 2007-226-Rev 03 | 24/04/2019 | VALID | / | Chemistry |
| Amoxicillin trihydrate | GlaxoSmithKline Research & Development Limited GB TW8 9GS London | R1-CEP 2000-010-Rev 04 | 04/06/2018 | VALID | / | Chemistry |
| Amoxicillin trihydrate Enzymatic process | North China Pharmaceutical Group Semisyntech Co., Ltd. CN 052 165 Shijiazhuang | R1-CEP 2014-220-Rev 00 | 09/11/2020 | VALID | / | Chemistry |
| Amoxicillin trihydrate Powder, compacted | THE UNITED LABORATORIES (INNER MONGOLIA) CO., LTD. CN 015 000 Bayannaoer | R1-CEP 2012-078-Rev 01 | 13/06/2018 | VALID | / | Chemistry |
| Amoxicillin trihydrate Enzymatic process, compacted | North China Pharmaceutical Group Semisyntech Co., Ltd. CN 052 165 Shijiazhuang | R0-CEP 2017-009-Rev 00 | 06/04/2017 | VALID | / | Chemistry |
| Amoxicillin trihydrate Compacted | INNER MONGOLIA CHANGSHENG PHARMACEUTICAL CO., LTD. CN 010 206 Tuoketuo | R0-CEP 2016-310-Rev 01 | 08/01/2020 | VALID | / | Chemistry |
| Amoxicillin trihydrate | Fersinsa GB S.A. De C.V. MX 25900 Ramos Arizpe | R0-CEP 2018-178-Rev 01 | 19/08/2020 | VALID | / | Chemistry |
| Amoxicillin trihydrate Compacted | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. CN 050 041 Shijiazhuang City | R1-CEP 2012-245-Rev 00 | 26/01/2018 | WITHDRAWN BY HOLDER | 16/09/2019 | Chemistry |
| Amoxicillin sodium Sterile, process E | Sandoz Industrial Products S.A. ES 08520 Les Franqueses Del Vallès | R1-CEP 1999-036-Rev 08 | 08/02/2018 | VALID | / | Chemistry |
| Amoxicillin trihydrate Compacted | ZHUHAI UNITED LABORATORIES CO., LTD. CN 519 040 Sanzao Town | R1-CEP 2007-191-Rev 03 | 06/02/2019 | VALID | / | Chemistry |
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:Hebei Expedition YACCA Pharmaceutical Co., Ltd. is subordinate to Hebei Yuanzheng Pharmaceutical Co., Ltd. the company was established in 2007.
Yuanzheng pharmaceutical has three factories and 26 GMP production lines. The company can annually produce 800 million veterinary powder injections, 300 million water injections, 80 million bags of powder (powder), 10 million bottles of disinfectants and 200 tons of API.
Staff size:300-399 persons
Registered capital:RMB 100 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
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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