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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 DateStatus
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WITHDRAWN BY HOLDER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WITHDRAWN BY HOLDER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WITHDRAWN BY HOLDER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WITHDRAWN BY HOLDER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:Venturepharm (Hainan) Co., Ltd.,is a group providing outsourced production service management for global pharmaceutical enterprises, which is authorized and managed by venturepharm Group Inc.

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