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Risperidone

CAS number: 106266-06-2

Molecular formula: C23H27FN4O2

molecular weight: 410.48

Chemical structure:

Producers shown on SFDA

(Record date:07/09/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Zhejiang Huahai Pharmaceutical Co., Ltd.

GMP, DMF
Valid till December 2020

Qilu Pharmaceutical Co., Ltd.

GMPValid till May 2022

Wuxi Jida Pharmaceutical Co., Ltd.

GMP
Valid till September 2020

Fu'an Pharmaceutical Group Ningbo team Pharmaceutical Co., Ltd.

GMP
Valid till March 2020

Jiangsu Nhwa Pharmaceutical Co., Ltd.

GMP
Valid till August 2020

Changzhou siyao Pharmaceutical Co., Ltd.

GMP
Valid till December 2020

Tipr Pharmaceutical Co., Ltd.

GMP
Valid till January 2021


Producers shown on EP

(Quoted from EP website;record date:07/09/2021)

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End Date
 Type
Risperidone
Janssen Pharmaceutical Ltd IE County Cork
  R0-CEP 2000-257-Rev 01
17/08/2004
WITHDRAWN BY HOLDER
07/03/2006
Chemistry
Risperidone
SYNTHON BV NL 6545 CM Nijmegen
  R0-CEP 2004-126-Rev 00
04/10/2006
WITHDRAWN BY HOLDER
15/04/2011
Chemistry
Risperidone
Medichem, S.A. ES 08970 Sant Joan Despí
  R1-CEP 2007-105-Rev 00
30/04/2013
VALID
/Chemistry
Risperidone
ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. CN 317 024 Linhai
  R1-CEP 2006-308-Rev 00
07/10/2013
VALID
/
Chemistry
Risperidone
LUPIN LIMITED IN 400 055 Mumbai
  R1-CEP 2007-160-Rev 01
13/09/2016
VALID
/
Chemistry
Risperidone
TORRENT PHARMACEUTICALS LIMITED IN 382 428 Village Bhat
  R1-CEP 2004-160-Rev 02
27/05/2020
VALID
/
Chemistry
Risperidone
RPG Life Sciences Limited IN 400 703 Navi Mumbai
  R1-CEP 2004-135-Rev 05
26/10/2015
VALID
/
Chemistry
Risperidone
TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva
  R1-CEP 2003-110-Rev 03
03/09/2020
VALID
/Chemistry
Risperidone 'RIS'
JUBILANT GENERICS LIMITED IN 571 302 Nanjangud
  R1-CEP 2006-046-Rev 02
18/12/2017
VALID
/
Chemistry
Risperidone Form 1
DR. REDDY'S LABORATORIES LIMITED IN 500 034 Hyderabad  R1-CEP 2009-243-Rev 02
05/01/2018
VALID
/
Chemistry
Risperidone
CADILA HEALTHCARE LIMITED IN 391 440 Dabhasa Village
  R1-CEP 2005-078-Rev 01
15/02/2021
VALID
/
Chemistry
Risperidone
Inke, S.A. ES 08755 Castellbisbal
  R1-CEP 2006-054-Rev 00
16/07/2012
VALID
/
Chemistry
Risperidone
CIPLA LIMITED IN 400 013 Mumbai
  R1-CEP 2005-037-Rev 02
28/07/2014
VALID
/
Chemistry
Risperidone
AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad
  R1-CEP 2005-094-Rev 02
13/12/2017
VALID
/
Chemistry
Risperidone
WUXI JIDA PHARMACEUTICAL CO., LTD. CN 214 445 Jiangyin
  R1-CEP 2012-264-Rev 00
13/02/2019
VALID
/
Chemistry
Risperidone
JANSSEN PHARMACEUTICA NV BE 2340 Beerse
  R1-CEP 2001-183-Rev 05
10/01/2017
VALID
/
Chemistry
Risperidone
JUBILANT GENERICS LIMITED IN 571 302 Nanjangud
  R1-CEP 2002-151-Rev 06
02/05/2018
VALID
/
Chemistry
Risperidone
MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad
  R1-CEP 2006-060-Rev 05
02/05/2019
VALID
/
Chemistry
Risperidone
VENKATA NARAYANA ACTIVE INGREDIENTS PRIVATE LIMITED IN 600 017 Chennai
  R0-CEP 2018-210-Rev 00
05/11/2020
VALID
/
Chemistry

Producer:Zhejiang Huahai Pharmaceutical Co., Ltd.was founded in 1989 and headquartered in Zhejiang, China. The company has nearly 7000 employees and more than 40 subsidiaries around the world (including China, the United States, Japan, Germany, etc.As a leading enterprise in the internationalization of Chinese medicine, Huahai pharmaceutical is the first pharmaceutical company in China to pass the FDA preparation quality certification and independently own the Anda document number. It is also the first Chinese pharmaceutical company to realize large-scale preparation sales in the United States. It has established China's pharmaceutical quality image in the world's high-end pharmaceutical market.

Staff size:About 7000 persons

Registered capital:RMB 1 billion 492 million


Producer:Qilu Pharmaceutical Co., Ltd. is one of the first batch of GMP certified enterprises by the State Food and drug administration. Among them, non sterile APIs (fermentation, chemical synthesis), sterile APIs and various preparations have passed the certification of the US Food and Drug Administration (USFDA), the European Drug Quality Council (EDQM), the UK MHRA, the South African pharmaceutical Regulatory Commission (MCC) and other national drug regulatory agencies.

Qilu pharmaceutical has seven production bases including preparation, chemical synthesis and biotechnology and antibiotic fermentation, covering an area of 1.9 million square meters. The company's automatic production line and other main production equipment and testing instruments are purchased from major professional pharmaceutical equipment manufacturers in the world.

Staff size:7000-7999 persons

Registered capital:RMB 60 million


Producer:Wuxi Jida Pharmaceutical Co., Ltd., a wholly-owned subsidiary invested by Kunming Jida Pharmaceutical Co., Ltd. in Jiangsu, was established in June 2005. Wuxi Jida Pharmaceutical Co., Ltd. is committed to developing cutting-edge generic chemical APIs that meet the requirements of the United States and EU countries, with the goal of building an international pharmaceutical raw material base. The company regards product quality as the foundation of enterprise survival and development. While obtaining China GMP certification, the company actively applies for high-end market certification such as FDA and COS in Europe.
Staff size:100-199 persons

Registered capital:RMB 73 million


Producer:Fu'an Pharmaceutical Group Ningbo team Pharmaceutical Co., Ltd., a subsidiary of Fu'an Pharmaceutical (Group) Co., Ltd., is the production base of antitumor API of the group. Founded in August 1992, Tianheng has been engaged in the pharmaceutical industry for more than 20 years and has fully passed the national GMP certification. The enterprise has national first-class medical science and technology strength and medical science and technology research center.

Staff size:400-499 persons

Registered capital:RMB 415 million


Producer:Jiangsu Nhwa Pharmaceutical Co., Ltd.  founded in 1978 and listed on Shenzhen Stock Exchange in 2008, is a pharmaceutical enterprise integrating science, industry and trade.

It has three large pharmaceutical GMP production bases for APIs and preparations, covering a total area of more than 900 mu. The enterprise has national certified workshops for APIs, solid preparations, water injections and lyophilized powder injections, and more than 10 automatic production lines for tablets, capsules, water injections and powder injections. At present, there are 39 kinds of APIs, 300 tons / year; More than 100 kinds of Western medicine preparations, 4 billion tablets (tablets) of solid preparations per year and 100 million injections per year.

According to the enterprise development strategy, we have made great efforts to save energy, reduce consumption and protect the environment, passed the international environmental certification (ISO14000), vigorously developed the export business of API, carried out EU edmf and FDA certification, and strive to gain a place in the international market.

Staff size:About 5000 persons

Registered capital:RMB 1 billion 8 million


Producer:Changzhou siyao Pharmaceutical Co., Ltd. has passed the three management system certification of national drug GMP, international environmental management ISO14001 and international occupational health and safety OHSMS18001, and three products have passed the certification of FDA and CEP of the European Union.

Current production capacity: 25 raw material intermediates, 100 tons, of which 50 tons are self exported; 20 million lyophilized powder needles and 100 million water needles; 2 billion capsules, tablets and controlled and sustained release preparations; 20 million creams and new transdermal patches.

Staff size:400-499 persons

Registered capital:USD 7.08 million


Producer:Tipr Pharmaceutical Co., Ltd.Research Institute was formerly directly under the State Food and drug administration. The pharmaceutical products produced by the company mainly involve antipsychotics, non steroidal anti-inflammatory, analgesia and detoxification, hypoglycemic, antiviral, cardio cerebrovascular and other fields. The dosage forms include small volume injection, tablet, granule, hard capsule, oral liquid and API. All dosage forms have passed GMP certification. It is a designated production unit of national psychotropic drugs and a comprehensive high-tech enterprise.
Staff size:300-399 persons

Registered capital:RMB 50 million


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