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.	GMP	Valid till December 2022
Jiangsu Hengrui Medicine Co.,Ltd.	GMP	Valid till November 2024
Zhejiang Hisun Pharmaceutical Co., Ltd.	GMP	Valid 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 CN 318 000 Taizhou City	R0-CEP 2010-331-Rev 01	14/09/2012	WITHDRAWN BY HOLDER	21/12/2020	Chemistry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Letrozole	MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad	R1-CEP 2013-214-Rev 00	01/10/2019	WITHDRAWN BY HOLDER	16/09/2020	Chemistry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