Home>APIs>

Clozapine

CAS number: 5786-21-0

Molecular formula: C18H19ClN4

molecular weight: 326.82

Chemical structure:

Producers shown on SFDA

(Record date:06/09/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Taizhou Xingming Pharmaceutical Co., Ltd.

GMP, DMFValid till December 2020

Wuhan Shiji Pharmaceutical Co., Ltd. 

GMP
Valid till March 2023

Huizhou Dongjiang Pharmaceutical Co., Ltd. 

GMP
/

Shouguang Fukang Pharmaceutical Co., Ltd. 

GMP
Valid till July 2022

Jinan Jinda Pharmaceutical Chemistry Co., Ltd.

GMP
Valid till December 2020

Wepon Pharmaceutical Group Co., Ltd.

GMP
Valid till December 2020



Producers shown on EP

(Quoted from EP website;record date:06/09/2021)

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Clozapine
SHOUGUANG FUKANG PHARMACEUTICAL CO., LTD. CN 262 700 Shouguang City
  R1-CEP 2012-006-Rev 00
12/04/2018
VALID
/Chemistry
Clozapine
AREVIPHARMA GMBH DE 01445 Radebeul
  R1-CEP 2006-205-Rev 01
05/11/2015
VALID
/Chemistry
Clozapine
WUHAN SHIJI PHARMACEUTICAL CO., LTD. CN 430 000 Wuhan
  R1-CEP 2010-087-Rev 01
23/04/2019
VALID
/Chemistry
Clozapine
Medichem, S.A. ES 08970 Sant Joan Despí
  R1-CEP 2008-151-Rev 00
13/07/2015
VALID
/Chemistry
Clozapine
MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad
  R1-CEP 2008-234-Rev 01
04/08/2017
VALID
/Chemistry
Clozapine
ZCL CHEMICALS LTD. IN 393 002 Ankleshwar
  R0-CEP 2018-192-Rev 01
12/02/2021
VALID
/Chemistry
Clozapine
Cambrex Profarmaco Milano S.r.l. IT 20067 Paullo
  R1-CEP 2005-128-Rev 02
11/06/2018
VALID
/Chemistry


Producer:Taizhou Xingming Pharmaceutical Co., Ltd. is a pharmaceutical enterprise specializing in the production of pharmaceutical raw materials and pharmaceutical intermediates. Its predecessor is Taizhou Jiaojiang Xingming chemical plant, which was founded in 1986.

At present, our company produces nearly 20 kinds of pharmaceutical intermediates and chemical products. The main products are adenine, clozapine, sulindac and intermediates.

Staff size:100-199 persons

Registered capital:RMB 2.28 million


Producer:Wuhan Shiji Pharmaceutical Co., Ltd. is a manufacturer dedicated to the R & D and production of chemical APIs. The company has established and implemented a complete quality management system, climbed to the world's top quality management level, and the quality system has been recognized by many well-known companies at home and abroad. The company has domestic pharmaceutical talents and has high-level technical force in drug R & D, production, registration and market development. The company's varieties have passed the official certification of FDA of the United States and EDQM of the European Union.

Staff size:About 50 persons

Registered capital:RMB 50 million


Producer:Huizhou Dongjiang Pharmaceutical Co., Ltd. (formerly Dongjiang pharmaceutical factory) was founded in 1984 and is subordinate to Huada Group Industrial Co., Ltd. Dongjiang pharmaceutical covers an area of 20000 square meters, with an annual output of 100 tons of clozapine. The cGMP of clozapine passed the FDA certification in April 2002.

Staff size:About 50 persons

Registered capital:RMB 3 million


Producer:Founded in 1993, Shouguang Fukang is a premier research and technology driven Chinese pharmaceutical enterprise with demonstrated capabilities for new drug research and development. It is ranked 42nd among China's Pharmaceutical Industry, employs 3,000 people and has a manufacturing campus of over 300 acres (2,000 Chinese acre).

Shouguang Fukang Pharmaceutical Co., Ltd. specializes in the development, manufacturing and marketing of 5 core product categories. They are PHARMACEUTCAL API, INTERMEDITES and FINISHED DOSE as well as BROMIDE COMPOUNDS and PAPER ADDITIVES, with a total of more than 60 products. Our production and sales volume of the API, trimethoprim (TMP), accounts for more than 70% of the world market. We are the No. 1 domestic producer and marketer of omeprazole, sulfamethoxazole (SMZ) and metformin HCl and the largest production base of bromide compounds. In a joint venture with BASF, we produce the following paper additives ; ODB-II, ODB-I, S-205 and EGTE, to the highest international standards.

Shouguang Fukang has established and implemented comprehensive quality assurance and quality control systems, with certifications of ISO9001/14001 and OHSAS18001. Shouguang Fukang was one of the first companies to receive SFDA GMP certification and five of our APIs, TMP, SMZ, omeprazole, metformin HCl and clozapine, have successfully passed USFDA inspection in Year 2011. We also gained COS certification from the European Directorate for the Quality of Medicines (EDQM). In addition we have successfully passed quality site audits from numerous renowned multinational corporations. Our company's products are domestically sold in 26 provinces and are exported to over 60 countries worldwide.

Staff size:1000-1999 persons

Registered capital:USD 156 million


Producer:Jinan Jinda Pharmaceutical Chemistry Co., Ltd. has 48 years of professional production history of chemical synthetic pharmaceutical APIs. It can produce 21 kinds of API and four kinds of intermediate products. Nineteen products have passed China GMP certification. It has passed the on-site inspection of FDA for five times. Furantoin series products are applying for CEP certificate, and DMF / edmf documents have been submitted for many varieties such as topidone hydrochloride and trisodium chloride.

Staff size:100-199 persons

Registered capital:RMB 1 million 769 thousand and 800


Producer:Founded in 1970, Wepon Pharmaceutical Group is a high-tech enterprise specializing in the R & D, production and sales of modern traditional Chinese medicine, chemical APIs and preparations. With a registered capital of 360 million yuan, it now has 6 subsidiaries, 192 drug production approval numbers and 16 dosage forms.

Staff size:500-599 persons

Registered capital:RMB 360 million


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