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. | GMP | Valid 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Risperidone | Janssen Pharmaceutical Ltd IE County Cork | R0-CEP 2000-257-Rev 01 | 17/08/2004 | WITHDRAWN BY HOLDER | 07/03/2006 | Chemistry |
Risperidone | SYNTHON BV NL 6545 CM Nijmegen | R0-CEP 2004-126-Rev 00 | 04/10/2006 | WITHDRAWN BY HOLDER | 15/04/2011 | Chemistry |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