Home>APIs>

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