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Ampicillin Sodium

CAS number: 69-52-3

Molecular formula: C16H18N3NaO4S

molecular weight: 371.387

Chemical structure:

Producers shown on SFDA

(Record date:25/08/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Sichuan Ren An Pharmaceutical Co., Ltd.
GMPValid till October 2020

Huabei Huari Pharmaceutical Co., Ltd. 

GMP
Valid till June 2018

Henan Xinxiang Huaxing Pharmaceutical Factory 

GMP, DMF
Valid till August 2020

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd

GMP
Valid till August 2024

Sinopharm Weiqida Pharmaceutical Co.,Led.i

GMP
Valid till May 2020
Hebei Union Pharmaceutical Co., Ltd.
GMP
Valid till November 2024

Zhuhai United Laboratories Co., Ltd. 

GMP
Valid till December 2023

Qilu Tianhe Pharmaceutical Co., Ltd. 

GMP
Valid till December 20221
North China Pharmaceutical Group Semisyntech Co., Ltd.
GMP, DMF 
Valid till November 2023
Shandong Lukang Pharmaceutical Co.,Ltd.
GMP
Valid till July 2023

Harbin Pharmaceutical Group General Pharmaceutical Factory

GMP
Valid till September 2024


Producers shown on EP

(Quoted from EP website;record date:25/08/2021)

Substance
Certificate Holder
Certificate Number
Issue  Date
Status
End date
Type
Ampicillin sodium
FRESENIUS KABI IPSUM S.R.L. IT 20051 Cassina de’ Pecchi
R1-CEP 2012-224-Rev 02
04/05/2021
VALID
/Chemistry
Ampicillin sodium Sterile
Istituto Biochimico Italiano "G. Lorenzini" S.p.A. IT 04011 Aprilia
R1-CEP 1999-169-Rev 05
26/07/2016
VALID
/Chemistry
Ampicillin sodium Sterile
FRESENIUS KABI IPSUM S.R.L. IT 20051 Cassina de’ Pecchi
R1-CEP 2007-227-Rev 04
11/02/2021
VALID
/Chemistry
Ampicillin sodium Sterile
AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad
R1-CEP 2008-001-Rev 04
10/03/2020
VALID/Chemistry
Ampicillin sodium Sterile and for parenteral preparations
ACS DOBFAR S.P.A. IT 20067 Tribiano
R1-CEP 2004-303-Rev 02
04/12/2020
VALID
/Chemistry
Ampicillin sodium Sterile
SANDOZ GMBH AT 6250 Kundl
R2-CEP 1993-005-Rev 07
17/10/2018
VALID
/Chemistry


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: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 Xinxiang Huaxing Pharmaceutical Factory is located in the Central Plains. It is close to Beijing Guangzhou railway in the West and national highway 107 in the East. The transportation is very convenient. The factory covers an area of more than 300000 square meters and a construction area of more than 130000 square meters, and has a group of high and intermediate technical teams and management personnel, with an annual production of more than 200 tons of inosine and more than 1000 tons of penicillin. Huaxing Pharmaceutical Factory has established a perfect quality control and quality assurance system, has advanced testing instruments at home and abroad, and its products are sold at home and abroad, which is praised by the majority of customers.

Staff size:100-199 persons

Registered capital:RMB 799 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: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:Hebei Union Pharmaceutical Co., Ltd. located at No. 58, Cangfeng Road, Shijiazhuang City, Hebei Province, is a wholly foreign-owned enterprise. It is a pharmaceutical enterprise in China that uses freeze-drying technology to produce penicillin antibiotics on a large scale. It was founded in October 1988. The company's products are divided into two series: API and preparation.

The company's institutional setup and staffing have been capable, especially the personnel directly engaged in production and management. They have received training in Italy and other countries and have a high level of standardization. The company's business process has been designed and demonstrated by colleges and universities, which has laid a solid management foundation for ensuring the company's product quality. The company has passed the national GMP certification and ISO9001 quality system certification as a whole. It dominates the same industry in China with "strong technical strength", "stable and reliable product quality", "high degree of production automation, high labor productivity and high enterprise reputation", and has maintained brand advantages for many years.

Staff size:50-99 persons

Registered capital:RMB 25.48 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:Qilu Tianhe Pharmaceutical Co., Ltd. established in 2006, has developed into a national high-tech enterprise integrating the production of API and its preparations, scientific research, pharmaceutical R & D outsourcing and other businesses. The company has advanced amikacin production workshop and tazobactam production workshop, advanced anti-tumor chemical synthesis production base, and aseptic lyophilization workshop group with advanced technology and large lyophilization scale.

The whole staff, comprehensive and whole process of the company are managed and controlled in strict accordance with GMP. High level technicians and world-class high-precision testing instruments and ensure the reliability of testing data and product quality. All products of the company have passed the new national GMP certification, and the main products have passed FDA, MHRA, TGA, PMDA, EDQM, who and German GMP certification.

Staff size:2000-2999 persons

Registered capital:RMB 612.5 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: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:Harbin Pharmaceutical Group General Pharmaceutical Factory belongs to Harbin Pharmaceutical Group Co., Ltd., which is a sino-foreign joint stock enterprise. It is a key antibiotic production base in China, a national large-scale first-level pharmaceutical enterprise, and one of the 500 large industrial enterprises in China.

Founded in 1958, the factory mainly produces penicillin and cephalosporin antibiotics, with a total of more than 30 kinds of apis and 18 kinds of dosage forms. It covers an area of 1.09 million square meters and has fixed assets of 2.156 billion yuan. It also has the production capacity of 1000 tons/year of 6-APA, 800 tons/year of 7-ACA, 4300 tons/year of antibiotic apis and intermediates and 3 billion doses of powder.

Staff size:3000-3999 persons

Registered capital:---


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