
Levetiracetam
CAS number: 102767-28-2
Molecular formula: C8H14N2O2
molecular weight: 170.20900
Chemical structure:
Producers shown on SFDA
(Record date:30/08/2021)
Producer | Documents | GMP Valid till(based on SFDA) |
Venturepharm (Hainan) Co., Ltd. | GMP | Valid till January 2024 |
Chongqing Shenghuaxi Pharmaceutical Co., Ltd. | GMP | Valid till June 2024 |
Second Pharma Co., Ltd. | GMP | Valid till November 2024 |
Renhe Yikang Pharmaceutical Co., Ltd. | GMP | Valid till October 2024 |
Shangyu Jingxin Pharmaceutical Co., Ltd. | GMP | Valid till August 2024 |
Shenzhen Salubris Pharmaceuticals Co., Ltd. | GMP | Valid till May 2024 |
Zhuhai United Laboratories Co., Ltd. | GMP | Valid till December 2023 |
Producers shown on EP
(Quoted from EP website;record date:30/08/2021)
Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | Type |
Levetiracetam | JUBILANT GENERICS LIMITED IN 571 302 Nanjangud | R1-CEP 2011-159-Rev 00 | 09/07/2018 | VALID | / | Chemistry |
Levetiracetam | ZHEJIANG CHANGMING PHARMACEUTICAL CO., LTD. CN 317 200 Tiantai | R1-CEP 2012-072-Rev 00 | 13/05/2019 | VALID | / | Chemistry |
Levetiracetam | SECOND PHARMA CO., LTD. CN 312 369 Shangyu City | R1-CEP 2014-219-Rev 00 | 15/12/2020 | VALID | / | Chemistry |
Levetiracetam | MYLAN LABORATORIES LIMITED IN 502 325 Hyderabad | R0-CEP 2011-089-Rev 03 | 01/07/2015 | WITHDRAWN BY HOLDER | 27/07/2017 | Chemistry |
Levetiracetam | DR. REDDY'S LABORATORIES LIMITED IN 500 034 Hyderabad | R1-CEP 2011-084-Rev 01 | 16/05/2018 | VALID | / | Chemistry |
Levetiracetam | SMS PHARMACEUTICALS LIMITED IN 500 034 Hyderabad | R1-CEP 2014-275-Rev 00 | 09/12/2020 | VALID | / | Chemistry |
Levetiracetam | PHALANX LABS PRIVATE LIMITED IN 500 034 Hyderabad | R0-CEP 2015-319-Rev 00 | 16/12/2016 | WITHDRAWN BY HOLDER | 17/03/2021 | Chemistry |
Levetiracetam | AMOLI ORGANICS PRIVATE LIMITED IN 400 021 Mumbai | R0-CEP 2014-270-Rev 02 | 24/10/2019 | VALID | / | Chemistry |
Levetiracetam Process II | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. CN 317 024 Linhai | R1-CEP 2012-325-Rev 00 | 20/02/2019 | VALID | / | Chemistry |
Levetiracetam Form-I | HETERO LABS LIMITED IN 500 018 Hyderabad | R0-CEP 2011-353-Rev 02 | 29/09/2015 | WITHDRAWN BY HOLDER | 18/05/2018 | Chemistry |
Levetiracetam Code product 2577 | ESTEVE QUIMICA S.A. ES 08038 Barcelona | R1-CEP 2011-042-Rev 05 | 15/06/2021 | VALID | / | Chemistry |
Levetiracetam Form I, LET Process | HETERO LABS LIMITED IN 500 018 Hyderabad | R0-CEP 2014-072-Rev 02 | 31/08/2016 | WITHDRAWN BY HOLDER | 18/05/2018 | Chemistry |
Levetiracetam | MSN LIFE SCIENCES PRIVATE LIMITED IN 503 101 Bhiknoor Village | R0-CEP 2019-300-Rev 01 | 07/05/2021 | VALID | / | Chemistry |
Levetiracetam Process B | DIVI'S LABORATORIES LIMITED IN 500 032 Hyderabad | R1-CEP 2014-079-Rev 01 | 04/12/2020 | VALID | / | Chemistry |
Levetiracetam | Neuland Laboratories Limited IN 500 034 Hyderabad | R1-CEP 2011-380-Rev 03 | 24/10/2019 | VALID | / | Chemistry |
Levetiracetam | SRINI PHARMACEUTICALS PRIVATE LIMITED IN 508 252 Choutuppal | R0-CEP 2018-176-Rev 00 | 12/05/2020 | VALID | / | Chemistry |
Levetiracetam | SOLARA ACTIVE PHARMA SCIENCES LIMITED IN 600 032 Chennai | R1-CEP 2012-324-Rev 01 | 20/10/2020 | VALID | / | Chemistry |
Levetiracetam | HANGZHOU HUADONG MEDICINE GROUP ZHEJIANG HUAYI PHARMACEUTICAL CO.,LTD CN 322 002 Yiwu | R1-CEP 2011-035-Rev 03 | 29/03/2019 | VALID | / | Chemistry |
Levetiracetam Process V | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. CN 317 024 Linhai | R0-CEP 2015-390-Rev 01 | 17/04/2018 | WITHDRAWN BY HOLDER | 01/04/2019 | Chemistry |
Levetiracetam | LUPIN LIMITED IN 400 055 Mumbai | R1-CEP 2013-242-Rev 01 | 03/11/2020 | VALID | / | Chemistry |
Levetiracetam Form I | AURORE LIFE SCIENCES PRIVATE LIMITED IN 500 081 Hyderabad | R0-CEP 2021-196-Rev 00 | 13/07/2021 | VALID | / | Chemistry |
Levetiracetam | AURORE LIFE SCIENCES PRIVATE LIMITED IN 500 081 Hyderabad | R0-CEP 2019-157-Rev 00 | 25/02/2021 | VALID | / | Chemistry |
Levetiracetam | TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva | R0-CEP 2011-302-Rev 04 | 03/11/2017 | WITHDRAWN BY HOLDER | 30/01/2018 | Chemistry |
Levetiracetam | ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO., LTD. CN 322 118 Hengdian | R1-CEP 2013-246-Rev 00 | 05/03/2020 | VALID | / | Chemistry |
Levetiracetam | AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad | R1-CEP 2010-245-Rev 03 | 14/11/2018 | VALID | / | Chemistry |
Levetiracetam | DIVI'S LABORATORIES LIMITED IN 500 032 Hyderabad | R1-CEP 2011-219-Rev 01 | 01/08/2018 | VALID | / | Chemistry |
Levetiracetam | ZHEJIANG JIANGBEI PHARMACEUTICAL CO., LTD. CN 318 017 Taizhou City | R1-CEP 2012-084-Rev 03 | 01/09/2020 | VALID | / | Chemistry |
Levetiracetam | SHANGYU JINGXIN PHARMACEUTICAL CO., LTD. CN 312 369 Shangyu | R1-CEP 2014-139-Rev 00 | 27/01/2021 | VALID | / | Chemistry |
Levetiracetam Form-I Process-II | HETERO LABS LIMITED IN 500 018 Hyderabad | R1-CEP 2014-113-Rev 01 | 19/07/2021 | VALID | / | Chemistry |
Levetiracetam | INNOVARE LABS PRIVATE LIMITED IN 531 011 Visakhapatnam | R0-CEP 2019-269-Rev 00 | 21/06/2021 | VALID | / | Chemistry |
Levetiracetam | ABA CHEMICALS (SHANGHAI) LIMITED CN 200 063 Shanghai | R1-CEP 2015-035-Rev 00 | 27/08/2021 | VALID | / | Chemistry |
Producer:
With 7 advanced API and preparation production bases in Asia, the company provides comprehensive production outsourcing services for global pharmaceutical enterprises. Customers can obtain professional support and services from the early stage of product development to large-scale production. All production bases of vante have passed GMP certification, and two API production bases have passed FDA certification.
Staff size:100-199 persons
Registered capital:RMB 194 million 870 thousand and 600
Producer:Chongqing Shenghuaxi Pharmaceutical Co., Ltd. was established in 1998 and officially restructured into a joint stock limited company in 2010; At present, the company has more than 900 employees. After more than ten years of development, it has been established Jingjing is a high-tech API and pharmaceutical preparation enterprise integrating R & D, production and sales.
Taking new drug R & D as the core competitiveness of the enterprise, the company has built a large-scale scientific research system, with more than 200 full-time scientific and technological developers; The company invests more than 12% of its sales revenue into new drug research and development every year. The company has three production bases, with more than ten fully sterile API and non sterile API production workshops, fine, drying and charter workshops, as well as a number of pharmaceutical preparation workshops; It has an annual production capacity of more than one billion yuan for APIs and pharmaceutical preparations.
Staff size:About 800 persons
Registered capital:RMB 66 million
Producer:Second Pharma Co., Ltd., was established in 2003, covering an area of 200 mu. It is the relocation of the API business of Beijing SECCO Pharmaceutical (formerly Beijing No. 2 pharmaceutical factory, subordinate to Beijing Pharmaceutical Group) from Beijing. It is jointly invested and established by SECCO pharmaceutical and Zhejiang XinHeCheng.
The company is recognized as a national high-tech enterprise, has established a perfect quality management system, is equipped with advanced instruments and equipment, and has passed the cGMP certification inspection of FDA and the PQ certification of who for many times. The company strictly performs its social responsibilities, attaches great importance to safety, environmental protection and labor employment, and has passed cleaner production audit, safety standardization acceptance, ISO14001 environmental management system certification and OHSAS18001 occupational health and safety management system certification.
Staff size:300-399 persons
Registered capital:RMB 80.12 million
Producer:Renhe Yikang Pharmaceutical Co., Ltd., a subsidiary of Renhe Yikang group, was established in 2016, with API workshop, oral solution workshop, small volume injection workshop and oral solid preparation workshop. Oral solution workshop and small volume injection workshop have obtained GMP certificate.
Staff size:300-399 persons
Registered capital:RMB 20 million
Producer:Shangyu Jingxin Pharmaceutical Co., Ltd. is a wholly-owned subsidiary of Zhejiang Jingxin Pharmaceutical Co., Ltd. Zhejiang Jingxin Pharmaceutical Co., Ltd. is one of the top 100 pharmaceutical enterprises in China and a listed pharmaceutical company. The company is located in the West Zone of Shangyu Industrial Park, Hangzhou Bay, Zhejiang Province. Its products are mainly the production of APIs. It is one of the largest production bases of quinolone APIs in China“ Cyclopropyl hydrochloride and levofloxacin hydrochloride occupy a large market share in China. API products sell well in Southeast Asia, South Asia, Latin America, Europe and other international markets.
The company has fully passed the national GMP certification, ISO14001 certification, simvastatin has obtained cos certificate, ciprofloxacin hydrochloride has obtained cos certificate, French GMP certificate, EU GMP certificate and KFDA registration certificate.
Staff size:500-599 persons
Registered capital:RMB 150 million
Producer:Shenzhen Salubris Pharmaceuticals Co., Ltd., established in 1998 and listed on Shenzhen Stock Exchange in 2009, is a comprehensive pharmaceutical listed company integrating pharmaceutical product R & D, production and sales. The company accurately distributes the global industrial chain, covering more than 30 countries and regions such as China, the United States, Germany, France and Japan. All products and production workshops of the company have passed the domestic GMP certification, Daya Bay production base has passed the EU GMP certification, and the key product Taijia has obtained the listing license of 12 EU countries. All kinds of products enjoy a good reputation in the industry.
Staff size:About 3500 persons
Registered capital:RMB 1 billion 115 million
Producer:Zhuhai United Laboratories Co., Ltd. is a subsidiary of The United Laboratories International Holdings Limited (United Lab). United Lab now has 11 major series of preparation products, more than 60 varieties, more than 120 product specifications, and nearly 50 varieties of 5 major series of API and intermediate products. All workshops of UL have passed the new version of GMP certification in China, and many products have successively obtained EU GMP certification and US FDA certification. With advanced enzymatic production technology, UL has become the first enterprise in China to obtain the EU CEP certificate of enzymatic amoxicillin, and a number of scientific and technological achievements have obtained national patents.
United Labowns advanced production equipment and adequate production capacity. Every year, it can produce 1.8 billion capsules, 1 billion tablets, 134 million sachets of granules, 86 million sachets of suspension, 20 million vials of oral solution, 117 million vials of powder injections, 37.8 million tubes of ointments, 28 million vials of lyophilized powder for injection, 24 million tubes of eye drops and about 300 million tubes of insulin preparation.
Staff size:2000-2999 persons
Registered capital:RMB 1 billion 678 million 396 thousand
For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +86 18402846978