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Letrozole

CAS number: 112809-51-5

Molecular formula: C17H11N5

molecular weight: 285.31

Chemical structure:

Producers shown on SFDA

(Record date:06/09/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Venturepharm (Hainan) Co., Ltd.

GMPValid till December 2022

Jiangsu Hengrui Medicine Co.,Ltd. 

GMPValid till November 2024

Zhejiang Hisun Pharmaceutical Co., Ltd.

GMPValid till November 2024


Producers shown on EP

(Quoted from EP website;record date:06/09/2021)

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Letrozole
FRESENIUS KABI ONCOLOGY LIMITED IN 741 235 Kalyani
  R1-CEP 2007-338-Rev 01
07/04/2020
VALID
/Chemistry
Letrozole
SCINOPHARM TAIWAN, LTD. TW 74144 Shan-Hua
  R1-CEP 2008-127-Rev 02
04/04/2019
VALID
/
Chemistry
Letrozole
SHILPA MEDICARE LIMITED IN 584 135 Raichur
  R1-CEP 2013-321-Rev 00
12/05/2020
VALID
/
Chemistry
Letrozole
APOTEX PHARMACHEM INDIA PVT. LTD IN 560 099 Bangalore
  R0-CEP 2011-066-Rev 00
24/05/2013
EXPIRED
29/05/2018
Chemistry
Letrozole
DR. REDDY'S LABORATORIES LIMITED IN 500 034 Hyderabad
  R1-CEP 2008-280-Rev 01
30/04/2015
VALID
/
Chemistry
Letrozole
HETERO LABS LIMITED IN 500 018 Hyderabad
  R1-CEP 2012-145-Rev 01
14/03/2019
VALID
/
Chemistry
Letrozole
Zhejiang Hisun Pharmaceutical Co., Ltd. CN 318 000 Taizhou City
  R0-CEP 2010-331-Rev 01
14/09/2012
WITHDRAWN BY HOLDER
21/12/2020
Chemistry
Letrozole
NATCO PHARMA LIMITED IN 500 034 Hyderabad
  R1-CEP 2007-150-Rev 03
14/02/2017
VALID
/
Chemistry
Letrozole
SYNTHON BV NL 6545 CM Nijmegen
  R1-CEP 2010-269-Rev 01
25/10/2016
VALID
/
Chemistry
Letrozole
Ind-Swift Laboratories Limited IN 160 101 Chandigarh
  R1-CEP 2009-105-Rev 03
26/01/2021
VALID
/
Chemistry
Letrozole
JIANGSU HENGRUI MEDICINE CO., LTD. CN 222 047 Lianyungang
  R1-CEP 2010-270-Rev 02
26/08/2019
VALID
/
Chemistry
Letrozole
NOVARTIS PHARMA AG CH 4002 Basel
  R0-CEP 2019-149-Rev 00
03/09/2020
VALID
/
Chemistry
Letrozole
CIPLA LIMITED IN 400 013 Mumbai
  R1-CEP 2010-300-Rev 00
08/07/2019
VALID
/Chemistry
Letrozole
MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad
  R1-CEP 2013-214-Rev 00
01/10/2019
WITHDRAWN BY HOLDER
16/09/2020
Chemistry
Letrozole
MAC CHEM PRODUCTS (INDIA) PVT. LTD. IN 400 059 Mumbai
  R1-CEP 2012-350-Rev 01
19/12/2019
VALID
/
Chemistry
Letrozole
SUN PHARMACEUTICAL INDUSTRIES LIMITED IN 400 063 Mumbai
  R1-CEP 2009-147-Rev 00
02/12/2015
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:Jiangsu Hengrui Medicine Co.,Ltd. is a pharmaceutical company engaged in the development and commercialization of innovative and high-quality drugs. 

The company has 28000 employees globally, fifth R & D centers were built around the globe and several subsidiaries were established in the US, EU, and Japan.

The company has 10 manufacturing facilities and most of them maintain USP, EUP, and JP. We are the first Chinese company that exported injections on a large scale to the US, EU, and Japan markets. All dosage forms of the company have passed the national GMP certification, and ifosfamide, etoposide, mesilar and tiotepa have passed the verification of FDA.

Staff size:About 30000 persons

Registered capital:RMB 6 billion 397 million


Producer:Zhejiang Hisun Pharmaceutical Co., Ltd. was founded in 1956. In 2000, Hisun issued A-shares in Shanghai stock exchange, but it continues to remain a state-owned enterprise. Hisun is one of the largest antibiotics and anti-tumor drug production bases in the country. It has won several titles, including first batch of innovative enterprises, national technology innovation demonstration enterprises, and "National Industrial Brand Demonstration Enterprise” of the Chinese Ministry of Industry and Information Technology. 

Hisun began as a small chemical factory and entered the pharmaceutical field in the early 1970s. Since its founding over 60 years ago in 1956, Hisun has amassed a total asset worth of 21.8 billion RMB. While Hisun is primarily engaged in the R&D, manufacturing, and sales and marking of API and final dosage forms of chemical and biological drugs, its core business has extended to include branded generic drugs, biosimilarst and other innovative drugs. 

Staff size:About 9000 persns

Registered capital:RMB 1 billion 169 million


For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +86 18402846978