Diclazuril

CAS number： 101831-37-2

Molecular formula： C17H9Cl3N4O2

molecular weight： 407.638

Chemical structure：

Producers shown on SFDA

(Record date:24/08/2021）

Producer	Documents	GMP Valid till(based on SFDA)
Zhejiang Guobang pharmaceutical Co.,Ltd.	GMP, DMF	Valid till May 2026
Changzhou Yabang-QH Pharmachem Co., Ltd.	GMP	Valid till December 2025
Lianyungang City Yahui Pharmachem Co., Ltd.	GMP	Valid till October 2023
Shandong Luxi Veterinary Medicine Co., Ltd.	GMP	Valid till August 2021

Producers shown on EP

(Quoted from EP website；record date:24/08/2021）

Substance	Certificate Holder	Certificate Number	Issue Date	Status	End date	Type
Diclazuril for veterinary use	ELANCO UK AH LIMITED GB L24 9LN Liverpool	R1-CEP 2014-164-Rev 00	23/11/2020	VALID	/	Chemistry
Diclazuril for veterinary use	Eli Lilly Benelux N.V. BE 1000 Brussels	R1-CEP 2003-107-Rev 03	26/02/2013	VALID	/	Chemistry
Diclazuril for veterinary use	ALIVIRA ANIMAL HEALTH LIMITED IN 531 019 Visakhapatnam	R0-CEP 2019-083-Rev 00	20/01/2021	VALID	/	Chemistry
Diclazuril for veterinary use	ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD. CN 312 369 Shangyu	R0-CEP 2018-234-Rev 01	07/04/2021	VALID	/	Chemistry

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:Changzhou Yabang-QH Pharmachem Co., Ltd.is subordinate to Jiangsu Qihui Pharmaceutical Technology Co., Ltd. the company's quality system has passed who certification, EU EDQM certification and US FDA certification, and obtained eu-gmp certificate. Most products have been registered with asmfs and CEPS in Europe, and some products vmfs have passed US FDA certification. EHS system has obtained the effective certification of ISO14001 environmental management system and OHSAS18001 occupational safety and health management system since 2007.

Staff size:200-299 persons

Registered capital:RMB 50 million

Producer:Lianyungang City Yahui Pharmachem Co., Ltd. is subordinate to Jiangsu Qihui Pharmaceutical Technology Co., Ltd. the company's quality system has passed who certification, EU EDQM certification and US FDA certification, and obtained eu-gmp certificate. Most products have been registered with asmfs and CEPS in Europe, and some products vmfs have passed US FDA certification. EHS system has obtained the effective certification of ISO14001 environmental management system and OHSAS18001 occupational safety and health management system since 2007, and has passed the safety, environmental protection and social responsibility audit of well-known pharmaceutical enterprises and third-party institutions at home and abroad for many times.

Staff size:About 50 persons

Registered capital:RMB 20 million

Producer:Shandong Luxi Veterinary Medicine Co., Ltd. was founded in 1990, covering an area of 70000 m2 and a construction area of 28000 m2. The company has 8 veterinary medicine workshops, including powder, premix, oral solution, ointment, ear drops, insecticide (solid), insecticide (liquid) / non chlorine disinfectant (liquid), powder / premix / granule and non chlorine disinfectant (solid), 13 production lines and feed additive workshops. The company's API and all preparation workshops have passed the GMP acceptance of veterinary drugs.

Staff size:100-199 persons

Registered capital:RMB 20.9 million

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

Diclazuril

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