Aripiprazole
CAS number: 129722-12-9
Molecular formula: C23H27Cl2N3O2
molecular weight: 448.39
Chemical structure:
Producers shown on SFDA
(Record date:06/09/2021)
Producer | Documents | GMP Valid till(based on SFDA) |
Topharman Shandong Co., Ltd. | GMP | Valid till November 2023 |
Chongqing Pharmaceutical Research Institute Co., Ltd. | GMP | Valid till February 2021 |
Chongqing Medical Engineering Institute Pharmaceutical Co., Ltd. | GMP | Valid till February 2024 |
Chengdu Hongda Pharmaceuticals Co., Ltd. | GMP | Valid till June 2019 |
Jiangsu Nhwa Pharmaceutical Co., Ltd. | GMP | Valid till March 2020 |
Jiangsu Hansoh Pharmaceutical Group Co., Ltd. | GMP | Valid till August 2022 |
Producers shown on EP
(Quoted from EP website;record date:06/09/2021)
Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | Type |
Aripiprazole Process III | AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad | R0-CEP 2020-300-Rev 00 | 18/02/2021 | VALID | / | Chemistry |
Aripiprazole | CADILA PHARMACEUTICALS LIMITED IN 393 002 Ankleshwar | R0-CEP 2016-308-Rev 00 | 04/09/2019 | VALID | / | Chemistry |
Aripiprazole | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. CN 317 024 Linhai | R1-CEP 2014-011-Rev 00 | 28/01/2020 | VALID | / | Chemistry |
Aripiprazole Process-II | HETERO LABS LIMITED IN 500 018 Hyderabad | R0-CEP 2017-254-Rev 01 | 02/09/2021 | VALID | / | Chemistry |
Aripiprazole | JUBILANT GENERICS LIMITED IN 571 302 Nanjangud | R1-CEP 2013-324-Rev 00 | 08/07/2021 | VALID | / | Chemistry |
Aripiprazole | SYNTHON BV NL 6545 CM Nijmegen | R0-CEP 2019-191-Rev 00 | 25/09/2020 | VALID | / | Chemistry |
Aripiprazole Type-I | HETERO LABS LIMITED IN 500 018 Hyderabad | R0-CEP 2013-361-Rev 02 | 01/02/2019 | VALID | / | Chemistry |
Aripiprazole Form B | Neuland Laboratories Limited IN 500 034 Hyderabad | R0-CEP 2017-289-Rev 00 | 26/02/2020 | VALID | / | Chemistry |
Aripiprazole | NIFTY LABS PVT. LTD. IN 500 016 Hyderabad | R0-CEP 2017-198-Rev 01 | 06/07/2021 | VALID | / | Chemistry |
Aripiprazole | Unichem Laboratories Limited IN 400 102 Mumbai | R0-CEP 2015-010-Rev 01 | 15/02/2018 | VALID | / | Chemistry |
Aripiprazole | ALEMBIC PHARMACEUTICALS LIMITED IN 390 003 Vadodara | R1-CEP 2013-292-Rev 00 | 23/11/2020 | VALID | / | Chemistry |
Aripiprazole Process II | AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad | R0-CEP 2018-134-Rev 02 | 01/07/2021 | VALID | / | Chemistry |
Aripiprazole | MACLEODS PHARMACEUTICALS LIMITED IN 400 059 Mumbai | R0-CEP 2015-229-Rev 00 | 09/01/2017 | VALID | / | Chemistry |
Aripiprazole | HEC PHARM CO., LTD. CN 443 300 Yidu City | R0-CEP 2016-208-Rev 01 | 24/07/2018 | VALID | / | Chemistry |
Aripiprazole | PHARMACEUTICAL SOLUTIONS FZCO AE P. O. Box 261176 Dubai | R0-CEP 2015-191-Rev 00 | 19/04/2017 | WITHDRAWN BY HOLDER | 27/07/2021 | Chemistry |
Aripiprazole | MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad | R1-CEP 2013-330-Rev 01 | 02/09/2021 | VALID | / | Chemistry |
Aripiprazole | OLON S.P.A. IT 20053 Rodano | R1-CEP 2014-188-Rev 00 | 02/06/2021 | VALID | / | Chemistry |
Aripiprazole | TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva | R0-CEP 2018-267-Rev 00 | 22/07/2020 | VALID | / | Chemistry |
Aripiprazole | EGIS Pharmaceuticals PLC HU 1106 Budapest | R1-CEP 2014-252-Rev 00 | 14/12/2020 | VALID | / | Chemistry |
Aripiprazole | ZCL CHEMICALS LTD. IN 393 002 Ankleshwar | R0-CEP 2016-021-Rev 02 | 07/05/2021 | VALID | / | Chemistry |
Aripiprazole | AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad | R1-CEP 2013-337-Rev 01 | 30/06/2021 | VALID | / | Chemistry |
Aripiprazole | PHARMACEUTICAL WORKS POLPHARMA S.A. PL 83-200 Starogard Gdanski | R1-CEP 2013-230-Rev 01 | 16/07/2021 | VALID | / | Chemistry |
Aripiprazole | MSN PHARMACHEM PRIVATE LIMITED IN 502 307 Pashamylaram Village | R1-CEP 2014-285-Rev 00 | 19/07/2021 | VALID | / | Chemistry |
Producer:Topharman Shandong Co., Ltd.has passed the GMP inspection of China, the United States, the European Union and Japan. Tefaman has four production workshops and four independent clean areas with complete equipment and facilities, which can effectively control the chemical reaction from - 70 ℃ to 250 ℃.
Staff size:100-199 persons
Registered capital:RMB 10 million
Producer:Chongqing Pharmaceutical Research Institute Co., Ltd.was established in 1950 and is now wholly owned by Chongqing Yaoyou Pharmaceutical Co., Ltd. The total area of the company's Laboratory for R & D is more than 7000 square meters, equipped with international advanced analysis and testing equipment, and more than 1000 sets of various instruments and equipment. It has applied for more than 270 Chinese invention patents, 24 PCT patents and 37 foreign patents, and obtained 76 Chinese patent authorizations and 20 foreign patent authorizations.
Staff size:About 50 persons
Registered capital:RMB 55 million
Producer:The current business status of Chongqing Medical Engineering Institute Pharmaceutical Co., Ltd. is cancelled.
Staff size:/
Registered capital:RMB 135 million
Producer:Chengdu Hongda Pharmaceutical Co., Ltd. is subordinate to Kanghong pharmaceutical, which was established in 2007. It is a manufacturing industry. Its main industry is manufacturing, and its service fields are the production of API (aripiprazole, mosapride citrate, venlafaxine hydrochloride, pramipexole hydrochloride and dextropiclon, API of class II psychotropic drugs).
Staff size:50-99 persons
Registered capital:RMB 4 millio
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:Founded in 1995, Jiangsu Hansoh Pharmaceutical Group Co., Ltd.is a leading R &D-driven pharmaceutical company in China. The company was listed on the Hong Kong Stock Exchange in June 2019
We have set up effective in house sales force with therapeutic area focus and strong academic promotion capabilities. We have established world class facilities and a manufacturing quality management system that compares with the cGMP requirements in China, the United States and Japan. Our manufacturing systems have obtained cGMP certifications from the U.S. FDA and the Japanese PMDA, and we plan to leverage our strong track record and experience to obtain additional quality system certifications and adopt advanced standards for entries into overseas markets. Our manufacturing quality management system enables us to produce all of our pharmaceutical products and the majority of our active pharmaceutical ingredients (APIs) in-h ouse.
Staff size:9000-9999 persons
Registered capital:RMB 1 million
For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +86 18402846978