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Cefprozil

CAS number: 92665-29-7

Molecular formula: C18H19N3O5S

molecular weight: 389.426

Chemical structure:

Producers shown on SFDA

(Record date:03/09/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Zhejiang Apeloa Tospo Pharmaceutical Co., Ltd.

GMP
Valid till October 2020

Nantong Kangxin Pharmaceutical Co., Ltd.

GMP
Valid till October 2020

Zhejiang Huafang Pharmaceutical Co., Ltd.

GMP
Valid till March 2019

Guangzhou Baiyunshan Chemical pharmaceutical factory

GMP
Valid till January 2016

Zhejiang Dongying Pharmaceutical Co., Ltd.

GMP
Valid till April 2024

Suzhou Shengda Pharmaceutical Co., Ltd.

GMP
Valid till December 2021

Qilu Antibiotics Pharmaceutical Co., Ltd.

GMP
Valid till August 2023

Fu'an Pharmaceutical (Group) Co., Ltd.

GMP
Valid till February 2019

Topfond Pharmaceutical Co., Ltd.

GMP
Valid till December 2020

Producers shown on EP

(Quoted from EP website;record date:03/09/2021)

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Cefprozil monohydrate
Qilu Antibiotics Pharmaceutical Co., Ltd. CN 250 105 Jinan
  R1-CEP 2013-093-Rev 00
20/06/2019
VALID
/Chemistry
Cefprozil monohydrate Powder and compacted
CENTRIENT PHARMACEUTICALS NETHERLANDS B.V. NL 2613 AX Delft
  R0-CEP 2017-301-Rev 00
06/06/2019
VALID
/Chemistry
Cefprozil monohydrate Process II
Qilu Antibiotics Pharmaceutical Co., Ltd. CN 250 105 Jinan
  R0-CEP 2020-252-Rev 00
19/02/2021
VALID
/Chemistry
Cefprozil monohydrate
AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad
  R1-CEP 2013-092-Rev 00
16/08/2019
VALID
/Chemistry


Producer:Zhejiang Apeloa Tospo Pharmaceutical Co., Ltd. is a member enterprise of Hengdian group, focusing on the R & D, production and sales of cephalosporin antibiotic APIs and pharmaceutical intermediates. It is the largest manufacturer of cefixime in China.

The company has passed iso9001a international quality system certification and ISO14001 environmental quality system certification. Among the company's existing products, cefixime and cefdinir APIs have passed the new GMP certification, florfenicol APIs have passed the GMP certification of veterinary drugs, oz has passed the PMDA certification of Japan, TTA and florfenicol have passed the FDA certification of the United States, and have passed the quality audit of Novartis, Roche, Merck and other large international companies, establishing a long-term friendly cooperative relationship with the world pharmaceutical giants.

Staff size:500-599 persons

Registered capital:RMB 130 million


Producer:Nantong Kangxin Pharmaceutical Co., Ltd. was established in 2006, covering an area of 86668 square meters. With fixed assets of 42.85 million yuan and a modern R & D center of 1000 square meters, it has formed an integrated system of science, industry and trade, and successfully developed and stored dozens of new products, including drugs, biopharmaceuticals and drug intermediates. At present, the company has passed the national GMP acceptance standard and established ERP enterprise resource management system; Built an internal LAN and fully implemented paperless office.
Staff size:About 50 persons

Registered capital:RMB 85.48847 million


Producer:Zhejiang Huafang Pharmaceutical Co., Ltd., founded in September 1993, covers an area of 46666.9m2, a construction area of 32009 m2, with total assets of 300 million yuan and fixed assets of 150 million yuan.   The company has a perfect safety, environmental protection and occupational health management system, and passed ISO9001, ISO14001 and OSHAS18001 system certification in 2008. The company is mainly engaged in anti infective drugs, anti allergic drugs, antifungal drugs, antipyretic and analgesic drugs and various intermediates, with an annual production capacity of 2500 tons.

Staff size:200-299 persons

Registered capital:RMB 27 million 887 thousand and 300


Producer:Guangzhou Baiyunshan Chemical pharmaceutical factory covers an area of 240000 square meters. It is a wholly-owned subsidiary of Guangzhou Baiyunshan Pharmaceutical Co., Ltd. controlled by Guangzhou Pharmaceutical Group. It is a large chemical pharmaceutical enterprise focusing on the production of cephalosporin APIs. Founded in 1987, it is the first batch of enterprises to obtain national GMP certification.

The factory's characteristic product cefathiamidine is the first semi synthetic cephalosporin first developed and listed by Chinese pharmaceutical enterprises in the world, which is protected by national patents. Cefixime was first listed in China by Baiyun Mountain and was only authorized by fujizawa, the original manufacturer of cefixime in China.

Staff size:300-399 persons

Registered capital:/


Producer:Zhejiang Dongying Pharmaceutical Co., Ltd. was established in 2005 and was wholly acquired by Zhejiang Guobang Pharmaceutical Co., Ltd. in March 2013. All products of the company have passed the national pharmaceutical GMP certification and are committed to the R & D, production and operation of cephalosporin antibiotics. It has an annual production capacity of 150 tons of cephalosporin sterile API, 600 tons of oral cephalosporin API and 1000 tons of pharmaceutical intermediates.

Staff size:100-199 persons

Registered capital:RMB 234 million 57 thousand and 776


Producer:Suzhou Shengda Pharmaceutical Co., Ltd.(formerly China Union Chempharma(suzhou) Co., Ltd.), founded in 2003, covers an area of more than 66000 square meters. It is a high-tech enterprise specializing in the R & D, production and sales of cephalosporin antibiotics. Product categories include oral API and sterile API. All products have passed the national GMP certification

Staff size:200-299 persons

Registered capital:RMB 10 million


Producer:Qilu Antibiotics Pharmaceutical Co., Ltd.was established in 1995, specializing in the production of cephalosporin APIs. It has three series of products: sterile APIs, oral APIs and pharmaceutical intermediates. The company has 26 listed varieties.

The company is the first in the same industry in China to pass the GMP certification in China and the EDQM certification in the European Union, and has successfully passed the official certification of Australia TGA, the FDA of the United States, Japan PMDA, South Korea MFDs, Britain EDQM, Cyprus MOH and Brazil Anvisa. It has obtained 11 CEP certificates for cephalosporins including the world's first CEP certificate. At present, there are 16 CEP certificates in China.

Staff size:2000-2999 persons

Registered capital:USD 319.27 million


Producer:Fu'an Pharmaceutical (Group) Co., Ltd., established on February 25, 2004, is the first enterprise in Changshou economic and Technological Development Zone to be successfully listed on Shenzhen GEM. The company has 9 wholly-owned and holding subsidiaries.

In 2020, it was rated as one of the top 100 in China's drug R & D comprehensive strength, one of the top 100 in China's chemical drug R & D strength, one of the top 100 in Chongqing's manufacturing industry, the Key Laboratory of industry and informatization of Chongqing Economic and Information Technology Commission, Chongqing new R & D institution and post doctoral research workstation.

Staff size:About 3000 persons

Registered capital:RMB 1 billion 190 million


Producer:Topfond Pharmaceutical Co., Ltd.is a large-scale large-scale enterprise integrating the production and sales of finished products, chemical synthesis raw materials and biological fermentation raw materials, and pharmaceutical management. Comprehensive pharmaceutical company.

Topfond Pharmaceutical was founded in 1969. In December 2000, the A shares of Topfond  Pharmaceutical was listed on the Shanghai Stock Exchange. After more than 40 years of hard work, the company has grown from small to large, from weak to strong, and has now developed into a large pharmaceutical group with 5 subsidiaries, 4 production plants and 1 national technology development center. It has 4000 employees. There are more than 4 people with total assets of more than 4 billion yuan. The company's production scale of finished preparations and fermentation tonnage of antibiotic raw materials are among the best in the industry in the country. Joined China General Technology Group in August 2008. In July 2013, it successfully realized the merger and absorption of shares exchange with China National Pharmaceutical and Health Industry Co., Ltd., and was officially included in China Pharmaceutical Management.

Topfond Pharmaceutical produces and reserves more than 10 types and nearly 600 varieties and specifications of products. It has an oral solid preparation workshop with an annual production capacity of nearly 6 billion tablets (tablets), the scale is among the forefront of the industry; the antibiotic fermentation tonnage is 12,000m³. The raw materials and some preparation products are exported to more than 20 countries and regions including Western Europe, Southeast Asia, the Middle East, North Africa, India, etc., and an international marketing network is initially formed.

Staff size:2000-2999 persons

Registered capital:RMB 420 million


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