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Ceftriaxone Sodium

CAS number: 74578-69-1

Molecular formula: C18H17N8NaO7S3

molecular weight: 576.56

Chemical structure:

Producers shown on SFDA

(Record date:03/09/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Zhuhai Lebang Pharmaceutical Co., Ltd.

GMP
/

Livzon Syntpharm Co.,Ltd.(zhuhaiftz)

GMP
Valid till August 2024

Changzhi Sanbao Biochemical Pharmaceutical Co., Ltd.

GMP
Valid till May 2024

Guangzhou Baiyunshan Chemical pharmaceutical factory 

GMP
Valid till April 2019

Qilu Antibiotics (Linyi) Pharmaceutical Co., Ltd.

GMP
Valid till February 2023

Liaoning Meiya Pharmaceutical Co., Ltd.

GMP
Valid till January 2019

Harbin Pharmaceutical Group General Pharmaceutical Factory

GMP
Valid till June 2020

Chongqing Tiandi Pharmaceutical Co., Ltd.

GMP
Valid till January 2019

Suzhou Dawnrays Pharmaceutical Co., Ltd.

GMP
Valid till November 2023

NCPC Hebei Huamin Pharmaceutical Co., Ltd.

GMP
Valid till October 2022

Henan Kangda Pharmaceutical Co., Ltd.

GMP, DMF
Valid till February 2022

Shenzhen China Resources Gosun Pharmaceuticals Co., Ltd.

GMP
Valid till September 2018

Guangxi Kelun Pharmaceutical Co., Ltd.

GMP
Valid till November 2023

Zhuhai United Laboratories Co., Ltd.

GMP
Valid till December 2023

Sinopharm Weiqida Pharmaceutical Co.,Ltd.i

GMP
Valid till June 2023

Hunan Nucien Pharmaceutical Co., Ltd.

GMP
Valid till January 2019

Qilu Antibiotics Pharmaceutical Co., Ltd.

GMP
Valid till December 2022

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd

GMP
Valid till December 2018

Shandong Luoxin Pharmaceutical Group Hengxin Pharmaceutical Co., Ltd.

GMP
Valid till August 2022

Luoxin Pharmaceutical Group Co., Ltd.

GMP
Valid till November 2018
Shandong Ruiying Xianfeng Pharmaceutical Co., Ltd.
GMP
Valid till November 2023

Shandong Lukang Pharmaceutical Co., Ltd.

GMP
Valid till July 2023

PKU HealthCare Corp., Ltd.

GMP
Valid till May 2019

China Union Chempharma(Suzhou) Co., Ltd.

GMP
Valid till July 2018

Reyoung Pharmaceutical Co., Ltd.

GMP
Valid till July 2023

Producers shown on EP

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

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Ceftriaxone sodium Sterile
Wockhardt Limited IN 393 002 Ankleshwar
  R1-CEP 2002-203-Rev 01
23/05/2011
WITHDRAWN BY HOLDER
04/05/2017
Chemistry
Ceftriaxone sodium Sterile 
AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad
  R1-CEP 2005-189-Rev 00
09/10/2013
WITHDRAWN BY HOLDER
06/02/2014
Chemistry
Ceftriaxone sodium Sterile
Ribbon S.r.l. IT 20145 Milano
  R0-CEP 2003-214-Rev 00
26/01/2005
EXPIRED
26/01/2010
Chemistry
Ceftriaxone sodium Sterile
ACS DOBFAR S.P.A. IT 20067 Tribiano
  R1-CEP 2011-393-Rev 00
26/10/2018
VALID
/Chemistry
Ceftriaxone sodium Sterile, Process T
CJ Corp. 100 802 Seoul
  R0-CEP 2001-087-Rev 01
29/07/2004
EXPIRED
30/04/2007
Chemistry
Ceftriaxone sodium Sterile; Process A
Hanmi Fine Chemical Co., Ltd. KR 429-848 Shihung-City
  R1-CEP 1998-013-Rev 02
12/11/2004
WITHDRAWN BY HOLDER
01/03/2006
Chemistry
Ceftriaxone sodium Sterile
KYONGBO PHARMACEUTICAL CO., LTD. KR 31501 Asan-si
  R1-CEP 2006-305-Rev 02
10/01/2020
VALID
/
Chemistry
Ceftriaxone sodium Sterile; synthetic process
HANMI FINE CHEMICAL CO., LTD. KR 15093 Siheung-si
  R1-CEP 2000-158-Rev 05
02/07/2019
VALID
/
Chemistry
Ceftriaxone sodium Sterile
F Hoffmann-La Roche Ltd. CH 4070 Basel
  R1-CEP 2001-084-Rev 01
06/05/2008
VALID
/
Chemistry
Ceftriaxone sodium sterile
Kukje Pharmaceutical Ind. Co., Ltd. KR 463-839 Seongnam-City
  R1-CEP 2000-017-Rev 00
29/05/2007
WITHDRAWN BY EDQM
13/07/2010
Chemistry
Ceftriaxone sodium sterile and bacterial endotoxins free
ACS DOBFAR S.P.A. IT 20067 Tribiano
  R1-CEP 2003-169-Rev 01
18/02/2011
VALID
/
Chemistry
Ceftriaxone sodium Sterile
FRESENIUS KABI IPSUM S.R.L. IT 20051 Cassina de’ Pecchi
  R1-CEP 2004-119-Rev 08
10/02/2021
VALID
/
Chemistry
Ceftriaxone sodium Sterile
Nectar Lifesciences Limited IN 140 507 Tehsil Dera Bassi
  R1-CEP 2010-342-Rev 00
11/10/2017
VALID
/
Chemistry
Ceftriaxone sodium Sterile
ORCHID PHARMA LIMITED IN 600 034 Chennai
  R1-CEP 1998-100-Rev 06
13/06/2018
VALID
/
Chemistry
Ceftriaxone sodium Sterile
SANDOZ GMBH AT 6250 Kundl
  R1-CEP 2004-137-Rev 04
02/09/2016
VALID
/
Chemistry
Ceftriaxone sodium Sterile
SANDOZ GMBH AT 6250 Kundl
  R1-CEP 1999-192-Rev 05
16/02/2018
VALID
/
Chemistry
Ceftriaxone sodium Sterile
Qilu Antibiotics Pharmaceutical Co., Ltd. CN 250 105 Jinan
  R1-CEP 2006-017-Rev 03
29/06/2018
VALID
/
Chemistry


Producer:Zhuhai Lebang Pharmaceutical Co., Ltd. was established on December 24, 2001. Its business scope includes: research, development, production and sales of self-produced sterile API (cefepime hydrochloride and ceftriaxone sodium); New drugs produced by bioengineering technology (produced and operated with drug production license).

Staff size:About 50 persons

Registered capital:Hong Kong dollar 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 yuan 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 company has nearly 500 employees. Its main products include ceftriaxone sodium, cefuroxime sodium, cefdixone sodium, ceftazidime, cefepime hydrochloride and cefpirome sulfate. The total annual capacity is 680 tons. 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.

Staff size:400-499 persons

Registered capital:RMB 128.28 million


Producer:Changzhi Sanbao Biochemical Pharmaceutical Co., Ltd. has total assets of 23.236 million yuan and covers an area of 85310.5 square meters (about 130 mu).

The company's main business: biochemical and chemical preparation production; Biochemical and chemical synthesis of APIs, pharmaceutical intermediates and fine chemicals, and the production of seven dosage forms and more than 50 varieties of injections, tablets, capsules, granules, powders, dry suspensions, eye drops, syrups and APIs.

Main production capacity: annual production of 300 million small volume injections, 1 billion tablets (granules and bags), 200 tons of biochemical API, 120 tons of cephalosporin sterile API and 500 tons of cephalosporin pharmaceutical intermediates

Staff size:About 50 persons

Registered capital:RMB 1996 million


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:Shandong Anhong Pharmaceutical Co., Ltd. (formerly Qilu Antibiotics (Linyi) Pharmaceutical Co., Ltd.) was incorporated in 2009 and is a subsidiary of Shandong Qilu Pharmaceutical Group Co., Ltd.

At present, the company has formed four series of chemical API production bases of cephalosporins, penem, anticancer and general drugs. Many product technical levels are at the international advanced level, and have passed the official certification at home and abroad, such as China GMP, the United States FDA, Japan PMDA, Germany GMP, South Korea KFDA, etc.

Staff size:1000-1999 persons

Registered capital:RMB 30 million


Producer:Liaoning Meiya Pharmaceutical Co., Ltd. is subordinate to the antibiotic division of Shanghai Pharmaceutical Group, which was established in 2002. Covering an area of 114.000 m2, it is divided into two production areas. One is the pharmaceutical intermediate production area, covering an area of 34000m2. There are five synthesis workshops, mainly producing cephalosporin pharmaceutical intermediates and other intermediates. It passed ISO9001 (2000) certification in 2003; The other is the API production area, covering an area of 80000m2. There is a synthesis workshop and aseptic workshop. The aseptic workshop has six production lines. It passed the GMP certification of China in February 2005. At present, the production capacity of sterile cephalosporin API is up to 500 tons / year, and the production capacity of pharmaceutical intermediates is up to 700 tons / year.
Staff size:400-499 persons

Registered capital:RMB 300 million


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:/


Producer:Chongqing Tiandi Pharmaceutical Co., Ltd., established in December 2003, is a holding subsidiary of the listed company Hainan sea Co., Ltd., with total assets of 230 million yuan. All products have passed GMP certification of the State Food and Drug Administration and ISO9001 certification of China Quality Certification Center. After 8 years of continuous development, the company has established a strategic partnership for sustainable development with many well-known pharmaceutical enterprises in China.

Staff size:500-599 persons

Registered capital:RMB 532 million 916 thousand and 370


Producer:Suzhou Dawnrays Pharmaceutical Co., Ltd.is subordinate to Dawnrays pharmaceutical Co., Ltd. Suzhou Dawnrays Pharmaceutical Co., Ltd., founded on December 8, 1995, is one of the earliest enterprises in China to pass the GMP certification. It is mainly engaged in the development, manufacture and sales of cephalosporin antibiotics and systemic specialty drugs.

Staff size:600-699 persons

Registered capital:USD 131.5 million


Producer:NCPC Hebei Huamin Pharmaceutical Co., Ltd.was officially established in April 2010. The company now has two antibiotic mother cores, 7-ACA and 7-ADCA, and 63 drug production numbers including raw materials and preparations. The products cover the leading varieties of cephalosporin generation 1 to 4. It has become the first complete industrial chain of North China pharmaceutical - a professional company for the production and operation of cephalosporin products, It has formed a command platform for the unified production and operation of cephalosporin from raw materials to preparations.

Staff size:1000-1999 persons

Registered capital:RMB 1 billion 450 million 139 thousand


Producer:Henan Kangda Pharmaceutical Co., Ltd. is wholly-owned by Beijing yuekang Pharmaceutical Group, with more than 300 employees. The company has a complete drug production, operation management system and quality management (GMP) system, and has 91 approval numbers of various drugs, including 19 APIs, 36 injections, 32 tablets and 4 capsules. It has 4 cephalosporin synthesis and sterile API production workshops, 1 non sterile API production workshop, injection (powder injection) production workshop and solid preparation production workshop (tablet and capsule).

Staff size:300-399 persons

Registered capital:RMB 90 million


Producer:Shenzhen China Resources Gosun Pharmaceuticals Co., Ltd.founded in 1991, is a wholly-owned subsidiary of China Resources Sanjiu Pharmaceutical Co., Ltd. 

the company has an annual total output of 450 tons of third-generation cephalosporin sterile powder, two API production lines, including four modern automatic production lines for powder injection, and an annual output of 200 million powder injection preparations; The main products of China Resources Jiuxin and its subordinate enterprises include more than 30 varieties, such as cefazolin sodium pentahydrate for injection, cefuroxime sodium for injection, cefonicid sodium for injection, cefotaxime sodium for injection and ceftizole sodium for injection; At the same time, we also produce sterile APIs and intermediates, and the product quality has reached the international advanced level.

Staff size:500-599 persons

Registered capital:RMB 500 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


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: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:Hunan Nucien Pharmaceutical Co., Ltd.(formerly Hunan Nonferrous Kaibai biopharmaceutical Co., Ltd.) focuses on the R & D, production and marketing of chemical drugs, and is committed to the R & D and industrialization of new drugs and specific drugs for major diseases and sudden diseases.     The research and development of Nan Xin pharmaceutical products is guided by the research and development of innovative drugs. The echelons of the products and existing products have been formed. Good layout has been achieved in a variety of anti influenza drugs, anti-cancer drugs, diabetic nephropathy drugs, cardiovascular and cerebrovascular drugs, anti infective drugs and so on.
Staff size:About 50 persons

Registered capital:140 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: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:Shandong Luoxin Pharmaceutical Group Hengxin Pharmaceutical Co., Ltd. is a wholly-owned subsidiary of Luoxin Pharmaceutical Group Co., Ltd.

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

Staff size:RMB 50 million

Registered capital:700-799 persons


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 Ruiying Pharmaceutical Group Co., Ltd. (formerly Shandong Ruiying Xianfeng Pharmaceutical Co., Ltd.) is a large pharmaceutical manufacturing enterprise integrating scientific research, pilot test, production and sales, covering the fields of biological fermentation, chemical synthesis, aseptic pharmacy and so on, forming a complete industrial chain.

The company has passed the international quality system certification, the GMP certification of the State Food and drug administration, the national EHS certification and the KFDA certification of South Korea, and has its own import and export rights. In addition to sales at home and abroad, its products are also exported to more than a dozen countries such as Europe, America and so on.

Staff size:900-999 persons

Registered capital:RMB 40 million


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:PKU HealthCare Corp., Ltd.is a core member enterprise of Founder group medical and pharmaceutical industry - Peking University medical industry group. It has more than 50 years of pharmaceutical manufacturing history and a national technology center. It is a key backbone enterprise of Chinese medicine, a national innovative pilot enterprise and a key high-tech enterprise of the national torch plan.

Peking University Pharmaceutical has a pharmaceutical manufacturing base built according to international cGMP in Liangjiang New Area, Chongqing. Its products cover more than 10 categories and more than 100 varieties, such as anti-tumor, psychoneurological, cardiovascular, immunosuppressive, anti microbial, antipyretic and analgesic. The company has a perfect quality assurance system, which has passed the FDA and EU GMP certification.

Staff size:About 800 persons

Registered capital:RMB 596 million


Producer: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:Reyoung Pharmaceutical Co., Ltd., established in 1966, is a modern comprehensive pharmaceutical company. Reyoung is given the title of National Trustworthy Company for Contract and Credit, Grade AAA Credit Company and Credit Company of Shandong Medical Industry. In the past 50 years, Reyoung inherits the mission “Reyoung Pharma., Benefit the public, insists the business concept “Innovation is the basis, Product quality is first. Never stop exploration and innovation, forging ahead with determination, and realizing the sustainable healthy development. Now Reyoung consists of 3 factory sites (covering an area of 1 million m2), possessing more than more than 30 workshops (9 categories, and 400 strengths) focusing on developing, manufacturing and selling Powder for Injection (including Lyophilized Powder for Injection), Small Volume Injection, Traditional Chinese Medicine, Tablets, Capsules, Granules, Suppository, Mixtures and APIs. All the workshops have been passed the cGMP. Reyoung also pass ISO system certificates. Reyoung also passed the oversea audit like PIC/S GMP.

Staff size:About 4000 persons

Registered capital:RMB 366.74 million


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