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Cefixime

CAS number: 79350-37-1

Molecular formula: C16H15N5O7S2

molecular weight: 453.45

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 May 2022

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd

GMP
Valid till January 2020

Guangzhou Baiyunshan Chemical Pharmaceutical Factory

GMP
Valid till January 2021

Guangdong Liguo Pharmaceutical Co., Ltd. 

GMP
Valid till October 2009

Tianjin Pharmaceutical Holdings Gencom Pharmacy Co., Ltd.

GMP
Valid till January 2020

Sichuan Renan Pharmaceutical Co., Ltd.

GMP, DMF
Valid till January 2021

Luoxin Pharmaceutical Group Stock Co., Ltd.

GMP
Valid till November 2018

Shandong Luoxin Pharmaceutical Group Hengxin Pharmaceutical Co., Ltd.

GMP
Valid till January 2020

Shandong Lukang Pharmaceutical Co., Ltd.

GMP
Valid till January 2020

Qilu Antibiotics Pharmaceutical Co., Ltd.

GMP
Valid till June 2022

Sinopharm Weiqida Pharmaceutical Co.,Ltd.

GMP
Valid till June 2018

Guangxi Kelun Pharmaceutical Co., Ltd.

GMP
Valid till September 2017


Producers shown on EP

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

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Cefixime 
SANDOZ GMBH AT 6250 Kundl
  R1-CEP 2009-347-Rev 02
31/10/2018
VALID
/Chemistry
Cefixime
HANMI FINE CHEMICAL CO., LTD. KR 15093 Siheung-si
  R1-CEP 2002-155-Rev 06
02/07/2019
VALID
/Chemistry
Cefixime Process 2
AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad
  R1-CEP 2011-243-Rev 00
05/04/2018
VALID
/Chemistry
Cefixime
Dhanuka Laboratories Ltd. IN 122 001 Gurgaon
  R1-CEP 2003-014-Rev 02
02/06/2014
WITHDRAWN BY EDQM
07/05/2018
Chemistry
Cefixime
SURYA PHARMACEUTICAL LTD. IN 160 009 Chandigarh
  R0-CEP 2007-314-Rev 00
21/01/2010
WITHDRAWN BY EDQM
10/01/2014
Chemistry
Cefixime
Astellas Pharma Inc. JP 174-8612 Tokyo
  R1-CEP 2001-073-Rev 00
13/07/2006
VALID
/Chemistry
Cefixime
SANDOZ PRIVATE LIMITED IN 400 705 Navi Mumbai
  R1-CEP 2001-449-Rev 00
14/05/2008
WITHDRAWN BY HOLDER
16/08/2018
Chemistry
Cefixime
Astellas Pharma Inc. JP 174-8612 Tokyo
  R1-CEP 1999-158-Rev 01
04/04/2007
VALID
/Chemistry
Cefixime
NECTAR LIFESCIENCES LIMITED IN 140 507 Tehsil Dera Bassi
  R1-CEP 2011-239-Rev 00
08/03/2019
VALID
/Chemistry
Cefixime
AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad
  R1-CEP 2007-055-Rev 02
13/12/2017
VALID
/Chemistry
Cefixime
LUPIN LIMITED IN 400 098 Mumbai
  R0-CEP 2004-123-Rev 00
01/08/2007
WITHDRAWN BY HOLDER
23/05/2012
Chemistry
Cefixime
ORCHID PHARMA LIMITED IN 600 034 Chennai
  R1-CEP 2002-125-Rev 02
30/06/2016
VALID
/Chemistry
Cefixime
KYONGBO PHARMACEUTICAL CO., LTD. KR 31501 Asan-si
  R0-CEP 2014-217-Rev 0002/12/2016
WITHDRAWN BY HOLDER
12/07/2021
Chemistry
Cefixime
SANDOZ PRIVATE LIMITED IN 400 705 Navi Mumbai
  R0-CEP 2010-192-Rev 00
08/01/2014
WITHDRAWN BY HOLDER
16/08/2018
Chemistry
Cefixime
PARABOLIC DRUGS LIMITED IN 140 201 Mohali District
  R1-CEP 2009-005-Rev 00
08/04/2016
VALID
/Chemistry
Cefixime
UNIMARK REMEDIES LIMITED IN 400 099 Mumbai
  R1-CEP 2008-124-Rev 00
20/11/2015
SUSPENDED
27/04/2021
Chemistry
Cefixime
NECTAR LIFESCIENCES LIMITED IN 140 507 Tehsil Dera Bassi
  R0-CEP 2017-042-Rev 01
19/02/2020
VALID
/Chemistry
Cefixime
Qilu Antibiotics Pharmaceutical Co., Ltd. CN 250 105 Jinan
  R1-CEP 2014-213-Rev 0019/02/2021VALID
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: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: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:Guangdong Liguo Pharmaceutical Co., Ltd., established in 1995, is a pharmaceutical enterprise specializing in the R & D and production of cephalosporins. The company passed the EU GMP certification in March 2013, providing a first opportunity for products to expand into the mainstream market. At present, the annual production capacity is 600 tons of sterile API and 600 tons of oral API.

Staff size:400-499 persons
Registered capital:Hong Kong dollar 97.36 million


Producer:Tianjin Pharmaceutical Holdings Gencom Pharmacy Co., Ltd.is a large international cephalosporin drug production base jointly invested by Tianjin Pharmaceutical Group and Tianjin Zhongxin Pharmaceutical Co., Ltd. in April 2003, covering an area of 137900 square meters, with a total investment of 400 million yuan and a construction area of 30000 square meters.  

Cephalosporin intermediates include gcle and 7-avca, among which gcle sells well in international markets such as India; Riboflavin sodium phosphate is in short supply in markets such as Japan. The company takes the lead in the domestic market.

Staff size:200-299 persons

Registered capital:RMB 189.5 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


Producer:Luoxin Pharmaceutical Group Co., Ltd. is a large pharmaceutical enterprise group integrating drug R & D, production, trade and medical and health services.

At present, the company has four manufacturing bases, including more than 50 production lines, including powder injection, lyophilized powder injection, solid preparation (including cephalosporins), spray, aerosol, pre encapsulation, large capacity injections, small volume injections, chemical raw materials, cephalosporins, and so on. There are more than ten dosage forms and more than 300 product specifications on the market. There are 48 national new drugs. The company can produce 1 billion powder injections, 500 million freeze-dried powder injections, 400 million large bottles of injections (bags), 500 million small volume injections, 7 billion tablets, 2 billion capsules, 300 million capsules, 80 million dry suspensions, 300 tons of micro pills, 1000 tons of raw materials, 30 million aerosol cans, spray ingredients, and pre encapsulated branches.

Staff size:2000-2999 persons

Registered capital:RMB 60.96 million


Producer:Shandong Luoxin Pharmaceutical Group Hengxin Pharmaceutical Co., Ltd. is a wholly-owned subsidiary of Luoxin Pharmaceutical Group Co., Ltd.
Staff size:RMB 50 million

Registered capital:700-799 persons


Producer:Shandong Lukang Pharmaceutical Co., Ltd. is the first large joint-stock enterprise in the pharmaceutical industry of Shandong Province, and the controlling shareholder is Shandong Lukang Pharmaceutical Group Co., Ltd. Lukang Pharmaceutical is a national large-scale first-class enterprise and the most complete variety of domestic pharmaceutical enterprises that have passed GMP certification, and is the first enterprise in the national western medicine system to pass ISO9001 quality system certification and ISO14001 environmental system certification“ The trademark of "Lukang brand" has been officially recognized as a well-known trademark in China by the Trademark Office of the State Administration for Industry and commerce. It is one of the five international well-known brands cultivated in Shandong Province. As of December 31, 2006, the total assets of the company reached 2.43 billion yuan.

All production workshops of the company have successfully passed GMP certification; Domestic sales are distributed in East China, North China, South China, northeast, northwest and southwest, and exported to Europe, North America and Southeast Asia. The company has actively adjusted the product layout and optimized the product structure, and has formed three series of product chains with 6-APA, 7-ACA and 7-ADCA as the parent core, realizing the successful leap from traditional antibiotic production to semi synthetic antibiotic production.

Staff size:6000 persons

Registered capital:RMB 880 million 200 thousand


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: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:Guangxi Kelun Pharmaceutical Co., Ltd. (formerly Guilin Dahua), now subordinate to Sichuan Kelun Pharmaceutical Co., Ltd., founded on November 22, 1996, is a manufacturer of cephalosporin antibiotic API and powder injection. The plant covers a total area of 79847.29 square meters, including a construction area of 14599.49 square meters. Guangxi Kelun became the first batch of GMP compliant units in 1999. At present, the factory is the only production base of cephalosporin antibiotics in Guangxi, which is fully equipped from API to preparation.
Staff size:400-499 persons

Registered capital:RMB 60 million


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