Enrofloxacin Base

CAS number： 93106-60-6

Molecular formula： C19H22FN3O3

molecular weight： 359.39

Chemical structure：

Producers shown on SFDA

(Record date:10/09/2021）

Producer	Documents	GMP Valid till(based on SFDA)
Zhejiang Langhua Pharmaceutical Co., Ltd.	GMP	Valid till June 2026
Zhejiang Guobang Pharmaceutical Co., Ltd.	GMP	Valid till January 2026
Shangyu Jingxin Pharmaceutical Co., Ltd.	GMP	Valid till December 2023

Producers shown on EP

(Quoted from EP website；record date:10/09/2021）

Substance	Certificate Holder	Certificate Number	Issue Date	Status	End date	Type
Enrofloxacin for veterinary use	ZHEJIANG LANGHUA PHARMACEUTICAL CO., LTD. CN 317 016 Linhai	R1-CEP 2012-034-Rev 01	12/04/2018	VALID		Chemistry
Enrofloxacin for veterinary use	ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD. CN 312 369 Shangyu	R1-CEP 2013-086-Rev 00	08/04/2019	VALID		Chemistry
Enrofloxacin for veterinary use	MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad	R1-CEP 2010-068-Rev 02	01/09/2021	VALID		Chemistry

Producer:Zhejiang Langhua Pharmaceutical Co., Ltd., a subsidiary of Weiya biotechnology holding group, was founded in 1986.

Langhua pharmaceutical has three R & D centers in Shanghai, Taizhou and Ningbo. The production base has repeatedly passed the cGMP audit of global regulators, including FDA of the United States, EDQM of the European Union, nmpa of China, Ministry of health, labor and welfare of Japan, who, etc., as well as the EHS special audit and PSCI audit of international pharmaceutical companies.

Staff size:400-499 persons

Registered capital:RMB 120 million

Producer:Zhejiang Guobang Pharmaceutical Co., Ltd. is the core enterprise of Guobang enterprise group, mainly producing and operating pharmaceutical raw materials, chemical intermediates and veterinary drugs. The whole enterprise has passed ISO9001:2000 quality system and ISO14001 environmental quality system certification. All products are produced in strict accordance with ICH Q7A standards and have passed the domestic GMP certification. American DMF and European DMF, which have independently compiled drugs, have a production capacity and market share of more than 30% of similar products in China.

Staff size:1000-1999 persons

Registered capital:RMB 138.8 million

Producer:Shangyu Jingxin Pharmaceutical Co., Ltd. is a wholly-owned subsidiary of Zhejiang Jingxin Pharmaceutical Co., Ltd. Zhejiang Jingxin Pharmaceutical Co., Ltd. is one of the top 100 pharmaceutical enterprises in China and a listed pharmaceutical company. The company is located in the West Zone of Shangyu Industrial Park, Hangzhou Bay, Zhejiang Province. Its products are mainly the production of APIs. It is one of the largest production bases of quinolone APIs in China“ Cyclopropyl hydrochloride and levofloxacin hydrochloride occupy a large market share in China. API products sell well in Southeast Asia, South Asia, Latin America, Europe and other international markets.

The company has fully passed the national GMP certification, ISO14001 certification, simvastatin has obtained cos certificate, ciprofloxacin hydrochloride has obtained cos certificate, French GMP certificate, EU GMP certificate and KFDA registration certificate.

Staff size:500-599 persons

Registered capital:RMB 150 million

For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +8618402846978

Enrofloxacin Base

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