Cefuroxime axetil

CAS number： 64544-07-6

Molecular formula： C20H22N4O10S

molecular weight： 510.47

Chemical structure：

Producers shown on SFDA

(Record date:05/09/2021）

Producer	Documents	GMP Valid till(based on SFDA)
Guangdong Liguo Pharmaceutical Co., Ltd.	GMP	Valid till October 2023
Anhui BBAC Likang Pharmaceutical Co., Ltd.	GMP, DMF	Valid till December 2020
NCPC Hebei Huamin Pharmaceutical Co., Ltd.	GMP, DMF	Valid till October 2023
Zhuhai United Laboratories Co., Ltd.	GMP	Valid till December 2019

Producers shown on EP

(Quoted from EP website；record date:05/09/2021）

Substance	Certificate Holder	Certificate Number	Issue Date	Status	End date	Type
Cefuroxime axetil amorphous	Deva Holding Inc. TR 59501 Cerkezköy / Tekirdag	R0-CEP 2003-176-Rev 00	23/06/2005	EXPIRED	16/07/2010	Chemistry
Cefuroxime axetil Amorphous	SANDOZ PRIVATE LIMITED IN 400 705 Navi Mumbai	R1-CEP 2002-131-Rev 00	29/01/2009	WITHDRAWN BY HOLDER	08/10/2018	Chemistry
Cefuroxime axetil Amorphous	SURYA PHARMACEUTICAL LTD. IN 160 009 Chandigarh	R0-CEP 2010-251-Rev 00	26/10/2012	WITHDRAWN BY EDQM	10/01/2014	Chemistry
Cefuroxime axetil	Kukje Pharmaceutical Ind. Co., Ltd. KR 463-839 Seongnam-City	R0-CEP 2002-190-Rev 01	18/11/2004	EXPIRED	07/07/2009	Chemistry
Cefuroxime axetil	GlaxoSmithKline Research & Development Limited GB TW8 9GS London	R1-CEP 2002-050-Rev 02	02/07/2013	WITHDRAWN BY HOLDER	24/10/2019	Chemistry
Cefuroxime axetil Amorphous	COVALENT LABORATORIES PRIVATE LIMITED IN 500 073 Hyderabad	R1-CEP 2011-172-Rev 02	09/03/2021	VALID	/	Chemistry
Cefuroxime axetil	Fako Ilaçlari A.S. TR 34390 Istanbul	R1-CEP 2000-398-Rev 00	23/02/2007	VALID	/	Chemistry
Cefuroxime axetil	Ranbaxy Laboratories Limited IN 122 015 Gurgaon	R1-CEP 2002-176-Rev 01	02/03/2010	WITHDRAWN BY HOLDER	28/04/2017	Chemistry
Cefuroxime axetil	ORCHID PHARMA LIMITED IN 600 034 Chennai	R1-CEP 2002-114-Rev 03	30/06/2016	VALID	/	Chemistry
Cefuroxime axetil Enzymatic process	ORCHID PHARMA LIMITED IN 600 034 Chennai	R1-CEP 2010-206-Rev 03	19/06/2020	VALID	/	Chemistry
Cefuroxime axetil Amorphous	TITAN PHARMACEUTICAL CO., LTD. (GUANGDONG) CN 517 447 Heyuan City	R0-CEP 2017-034-Rev 02	02/09/2021	VALID	/	Chemistry
Cefuroxime axetil	DAEWOONG BIO INC. KR 445-746 Hwasung-City	R1-CEP 2003-114-Rev 00	04/02/2011	VALID	/	Chemistry
Cefuroxime axetil	UNIMARK REMEDIES LIMITED IN 400 099 Mumbai	R1-CEP 2007-198-Rev 01	17/07/2015	VALID	/	Chemistry
Cefuroxime axetil Amorphous	Wockhardt Limited IN 400 051 Mumbai	R1-CEP 2003-051-Rev 01	17/12/2009	VALID	/	Chemistry
Cefuroxime axetil Amorphous	NECTAR LIFESCIENCES LIMITED IN 140 507 Tehsil Dera Bassi	R1-CEP 2009-045-Rev 02	28/05/2019	VALID	/	Chemistry
Cefuroxime axetil	AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad	R1-CEP 2002-252-Rev 06	05/03/2021	VALID	/	Chemistry
Cefuroxime axetil	Dhanuka Laboratories Ltd. IN 122 001 Gurgaon	R0-CEP 2011-173-Rev 00	18/03/2013	WITHDRAWN BY EDQM	07/05/2018	Chemistry
Cefuroxime axetil	PARABOLIC DRUGS LIMITED IN 140 201 Mohali District	R1-CEP 2008-203-Rev 00	05/05/2015	VALID	/	Chemistry
Cefuroxime axetil Amorphous, Process-II	Nectar Lifesciences Limited IN 140 507 Tehsil Dera Bassi	R0-CEP 2016-170-Rev 00	16/12/2016	VALID	/	Chemistry
Cefuroxime axetil	SUN PHARMACEUTICAL INDUSTRIES LIMITED IN 400 063 Mumbai	R1-CEP 2001-353-Rev 04	19/02/2018	VALID	/	Chemistry

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:Anhui BBAC Likang Pharmaceutical Co., Ltd., a wholly-owned subsidiary of BBCA Pharmaceutical , was established in November 2010 with a registered capital of 66 million yuan. It is mainly engaged in the production and sales of APIs and the import and export of its products and technologies. The company is located in Bengbu high tech Development Zone, covering an area of about 135 mu.

At present, the company has an annual production capacity of 8000 tons of paracetamol and 2000 tons of dc90. The product quality meets the requirements of Chinese Pharmacopoeia (cp2010), European Pharmacopoeia (EP7) and American Pharmacopoeia (usp36), and has been highly praised by customers in domestic and foreign markets.

Staff size:200-299 persons

Registered capital:RMB 138 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

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

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