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Amoxicillin

CAS number: 26787-78-0

Molecular formula: C16H19N3O5S·3H2O

molecular weight: 419.46

Chemical structure:

Producers shown on SFDA

(Record date:25/08/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Inner Mongolia Changsheng Pharmaceutical Co., Ltd.

GMP

Valid till March 2020

Zhuhai United Laboratories Co., Ltd.
GMP
Valid till December  2023
The United Laboratories (inner Mongolia) Co., Limited
GMP

Valid till February 2021

North China Pharmaceutical Group Semisyntech Co., Ltd.
GMP
Valid till NovembeR 2023 
Sinopharm Weiqida Pharmaceutical Co.,Led.
GMP, DMF

Valid till March 2022

Huabei Huari Pharmaceutical Co., Ltd. 
GMPValid till March 2019
Henan Lvyuan Pharmaceutical Co.,Ltd.
GMP, DMF
Valid till October 2020
Cspc Heibei Zhongrun Pharmaceutiacl Co., Ltd.
GMP

Valid till May 2022

Sichuan Ren An Pharmaceutical Co., Ltd.
GMP
Valid till December 2021
Shandong Bairui Pharmaceutical Co., Ltd.
GMPValid till June 2024
Reyoung Pharmaceutical Co., Ltd.
GMPValid till May  2019
Livzon Syntpharm Co.,ltd.(zhuhaiftz)
GMP/
Harbin Pharmaceutical Group Co., Ltd. General Pharm. Factory
GMP
Valid till September 2024
Shandong Lukang Pharmaceutical Co.,Ltd.
GMPValid till September 2023
Hunan Er-Kang Pharmaceutical Co., Ltd.
GMPValid till September 2018


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WITHDRAWN BY EDQM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WITHDRAWN BY HOLDER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WITHDRAWN BY HOLDER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
24/04/2019VALID
/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:Inner Mongolia Changsheng Pharmaceutical Co., Ltd a wholly foreign-owned enterprise, was established in October 2003. It mainly produces and operates amoxicillin, ampicillin API and related pharmaceutical intermediates. There are more than 1300 employees, the company covers an area of 1500 mu, the cumulative investment in fixed assets has reached 2.5 billion yuan, and the cumulative tax paid has exceeded 1 billion yuan; In 2019, the sales revenue was nearly 1.5 billion yuan and the profit and tax was 150 million yuan; The main products have passed the international high-end certification such as FDA of the United States and CEP of the European Union; Export products account for 40% of the company's total sales, and the products are sold to more than 20 countries and regions around the world.

Staff size:900-999 persons

Registered capital:Hong Kong dollar 271.6472 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:The United Laboratories (inner Mongolia) Co., Limited is subordinate to UL International Holding Co., Ltd. and is the fifth pharmaceutical factory built in China. At present, the total investment is nearly 8.1 billion yuan and the total number of employees is more than 5400. It is the production base with the largest investment and the most complete industrial chain of UL and one of the largest drug production bases in Northwest China.

Staff size:5000-5999 persons

Registered capital:RMB 2920 million


Producer:Huabei Pharmaceutical Group Co., Ltd. is the largest pharmaceutical enterprise in China, located in Shijiazhuang, the capital of Hebei Province.

By the end of 2018, Huayao group had total assets of 20.6 billion yuan, nearly 15000 employees, more than 40 subsidiaries (branches), and three national innovation platforms: National Engineering Research Center for microbial drugs, State Key Laboratory for antibody drug development, national local joint engineering laboratory for antibiotic enzyme catalysis and crystallization technology. Its main products are chemical pharmaceuticals There are nearly 1000 product specifications in the fields of modern biotechnology drugs, vitamins and nutritional health products, modern traditional Chinese medicine, biological agricultural and veterinary drugs, and the treatment fields cover anti infection, cardio cerebrovascular, nephropathy, anti-tumor and immune regulation. The process route and production layout of the main production units are designed and implemented in accordance with the current version of GMP in Europe and America and the new version of GMP in China, It has a modern pharmaceutical production platform with international leading level.

Staff size:900-999 persons

Registered capital:RMB 128.68952 million 


Producer:Sinopharm Weiqida Pharmaceutical Co.,Led.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:Huabei Huari Pharmaceutical Co., Ltd. is a Sino Japanese cooperative enterprise jointly established by Huabei pharmaceutical and Elista Co., Ltd. and a mainstream manufacturer of procaine penicillin, benzylpenicillin and other semi synthetic penicillin series products in the world. Adhering to the 50 year penicillin manufacturing history and quality of Huabei pharmaceutical, with advanced production technology, highly scientific and perfect quality assurance system, the quality of Huari products meets and exceeds the standards of Chinese Pharmacopoeia, American Pharmacopoeia, British Pharmacopoeia and European Pharmacopoeia. It can provide complete DMF, edmf, cos and other relevant documents. Users are in more than 30 countries and regions around the world, Highly praised. The company passed the national GMP certification in December 1998 and became the first sterile API manufacturer in China to pass the national certification. Hebei Huari Pharmaceutical Co., Ltd. has been committed to FDA certification since its establishment, and has accepted FDA on-site inspection in March 2003.The company is now deregistered.

Staff size:/

Registered capital:RMB 52.43152 million


Producer:Henan Lvyuan Pharmaceutical Co., Ltd. is a modern high-tech pharmaceutical joint-stock enterprise jointly invested and constructed by Liuzhuang village and several domestic companies. It covers an area of 266800 square meters, a planned construction area of 110000 square meters and a total investment of more than 1 billion yuan

Lvyuan pharmaceutical attaches great importance to the introduction, training and development of talents, and has established a perfect quality assurance system. The company has more than 1000 employees, of which more than 30% are professional technicians, who are fully responsible for the R & D and quality supervision of the company's products.

Staff size:100-199 persons

Registered capital:RMB 650 million


Producer:CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.is a joint venture invested and established by CSPC Pharmaceutical Group Co., Ltd. in the mainland. It is a professional production base of antibiotic raw materials and preparations in China and a major supplier of non patented drugs in China. The market share of amoxicillin dispersible tablets and Amoxicillin Capsules produced by the company ranks first in the industry.

The "zero defect items" of cephalosporin powder injection, tablet and capsule passed the FDA certification for the first time; The annual output is 1.2 billion powder injections, 4.4 billion capsules and 800 million tablets; It is divided into four dosage forms: powder injection, capsule, tablet and granule; More than 150 specifications of antibiotics were produced. All kinds of products have passed GMP certification and meet the latest national standards.

Staff size:2000-2999 persons
Registered capital:RMB 678 million 555 thousand and 900


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


Producer:Shandong Bairui Pharmaceutical Co., Ltd. is a semi synthetic antibiotic API production base integrating scientific research, development, pilot test, production and sales. The company has been cancelled.

Staff size:/

Registered capital:RMB 12 million


Producer:Reyoung Pharmaceutical Co., Ltd, which was converted into a limited company under the PRC law in 1998 and is now a Singapore-listed company, was established in 1966. The company is an ISO9001、ISO14001、OHS18001 authentication enterprise and possess postdoctoral programme and ERP system and so on. The trademark of “reyoung” is famous trademark of China.

 reyoung It covers an area of more than 343,000 square meters, with the total asset of USD500 millions. There is more than 4000 staff in Reyoung Pharm., of whom approximate 21 percents of the total staff is sales&marketing personnel. All the workshops, which can produce eight categories and more than 340 specifications of pharmaceutical products including tablets, capsules, granules, sterile active ingredients, small volume injection, powder for injection, lyophilized powder for injection, suppository, have passed GMP certification of the Chinese SFDA. The sales and marketing network for its products covers all the big and medium cities throughout the mainland of PRC.

Staff size:3000-3999 persons

Registered capital:RMB 12 million


Producer:Livzon Syntpharm Co.,ltd.(zhuhaiftz) a wholly-owned subsidiary of Lizhu Pharmaceutical Group Co., Ltd., was established in 1993 and is located in Zhuhai Free Trade Zone, Guangdong Province.

By the end of 2008, the company had invested more than 300 million in fixed assets, covering an area of about 100000 square meters. It is a API base based on cephalosporin semi synthetic antibiotics built according to GMP standards. The production lines of the whole company have passed GMP certification. The production process and economic and technical indexes of all products have reached the domestic advanced level, and the product quality meets the CP and USP Pharmacopoeia standards. With an annual output value and sales of more than 600 million yuan, it has become one of the largest cephalosporin sterile API production bases in China.

Staff size:400-499 persons

Registered capital:RMB 128.28 million


Producer:Harbin Pharmaceutical Group Co., Ltd. General Pharm. Factory is a key antibiotic production base in China and a large national first-class pharmaceutical enterprise. It is the backbone of Harbin Pharmaceutical Group and one of the pillar enterprises of Harbin local economic development. Harbin Pharmaceutical adheres to the enterprise philosophy of "above quality and pursuing human health", carries forward the enterprise spirit of "carrying things with great virtue and being cautious and strong", follows the business purpose of "the best quality and the best service", constantly develops and innovates and strives to forge ahead.

The Pharmaceutical General Factory of Harbin Pharmaceutical Group is subordinate to Harbin Pharmaceutical Group Co., Ltd. It is a Sino foreign joint-stock enterprise. It is a key antibiotic production base in China, a national large-scale first-class pharmaceutical enterprise, and one of China's 500 large industrial enterprises.

Staff size:3000-3999 persons

Registered capital:---


Producer:Shandong Lukang Pharmaceutical Co., Ltd. (hereafter referred to as Lukang Pharma), found in 1966 in Jining, Shandong Province, is a state-owned large-scale comprehensive pharmaceutical enterprise, which was listed on the main board in 1997

By far, the company has a total asset of RMB 6.6 billion and more than 6,000 employees. The company owns 13 joint ownership enterprises, including 5 wholly-owned subsidiaries, 6 holding companies and 2 joint ventures. Qinghai Lukang Dadi company is the production base of Chinese traditional medicine and Tibetan traditional medicine, Shandong Lukang Saite company is the production base of Non Penicillin and Non-Cephalosporin FDFs, and Shandong Lukang Biological Pesticides company is the production base of Agricultural Chemical.

Staff size:About 6200 persons

Registered capital:RMB 880 million 200 thousand


Producer:Hunan Er-Kang Pharmaceutical Co., Ltd. is an enterprise focusing on the field of pharmaceutical excipients, and it is also one of the few enterprises in China that have the registration approval of new penicillin antibiotics - sulbacillin sodium API and finished products. At present, the company has 120 varieties of excipients, 43 varieties of APIs and 148 approvals of finished drugs, forming a new comprehensive development pattern focusing on pharmaceutical excipients and three series of products of APIs and finished drugs.

Staff size:About 1700 persons

Registered capital:RMB 2 billion 63 million


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