
Cefoperazone Sodium
CAS number: 62893-20-3
Molecular formula: C25H26N9NaO8S2
molecular weight: 667.65
Chemical structure:
Producers shown on SFDA
(Record date:03/09/2021)
Producer | Documents | GMP Valid till(based on SFDA) |
Suzhou Dawnrays Pharmaceutical Co., Ltd. | GMP | Valid till November 2023 |
Qilu Antibiotics Pharmaceutical Co., Ltd. | GMP | Valid till February 2023 |
NCPC Hebei Huamin Pharmaceutical Co., Ltd. | GMP | Valid till June 2021 |
Zhuhai United Laboratories Co., Ltd. | GMP | Valid till December 2023 |
Henan Kangda Pharmaceutical Co., Ltd. | GMP | Valid till January 2022 |
Guangdong Liguo Pharmaceutical Co., Ltd | GMP | / |
Sinopharm Weiqida Pharmaceutical Co.,Ltd. | GMP | Valid till September 2018 |
Luoxin Pharmaceutical Group Co., Ltd. | GMP | Valid till August 2018 |
Shandong Luoxin Pharmaceutical Group Hengxin Pharmaceutical Co., Ltd. | GMP | Valid till August 2022 |
Harbin Hejia Pharmaceutical Co., Ltd. | GMP | Valid till May 2022 |
Guangzhou Baiyunshan chemical pharmaceutical factory | GMP | Valid till January 2021 |
Shandong Ruiying Pioneer Pharmaceutical Co., Ltd. | GMP, DMF | Valid till November 2023 |
Reyoung Pharmaceutical Co., Ltd. | GMP | Valid till October 2023 |
Shandong Lukang Pharmaceutical Co., Ltd. | GMP | Valid till August 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 |
Cefoperazone sodium Sterile | FRESENIUS KABI IPSUM S.R.L. IT 20051 Cassina de’ Pecchi | R1-CEP 2003-277-Rev 04 | 10/02/2021 | VALID | / | Chemistry |
Cefoperazone sodium Sterile | Qilu Antibiotics Pharmaceutical Co., Ltd. CN 250 105 Jinan | R1-CEP 2007-202-Rev 02 | 14/05/2020 | VALID | / | Chemistry |
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: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: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: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: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: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: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: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:Harbin Hejia Pharmaceutical Co., Ltd., established in May 1995, is a wholly-owned subsidiary of Hebei Hejia Pharmaceutical Technology Group Co., Ltd. its business scope is the production of chemical raw materials (cephalosporins), preparations (cephalosporins), tablets, capsules and granules. Self operated or acting as an agent for the import and export of various commodities (except for commodities and Technologies Prohibited or restricted by the state).
Staff size:100-199 persons
Registered capital:RMB 65.5 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 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: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
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: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
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