Citalopram Hydrobromide

CAS number： 59729-32-7

Molecular formula： C20H22BrFN2O

molecular weight： 405.35

Chemical structure：

Producers shown on SFDA

(Record date:07/09/2021）

Producer	Documents	GMP Valid till(based on SFDA)
Zhejiang Huahai Pharmaceutical Co., Ltd.	GMP, DMF	Valid till June 2023
Wuxi Jida Pharmaceutical Co., Ltd.	GMP	Valid till September 2020
Sichuan Kelun Pharmaceutical Co., Ltd.	GMP	Valid till January 2021
Jiangsu Nhwa Pharmaceutical Co., Ltd.	GMP	Valid till October 2020

Producers shown on EP

(Quoted from EP website；record date:07/09/2021）

Substance	Certificate Holder	Certificate Number	Issue Date	Status	End date	Type
Citalopram hydrobromide	ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. CN 317 024 Linhai	R1-CEP 2010-037-Rev 01	17/07/2020	VALID	/	Chemistry
Citalopram hydrobromide	SHODHANA LABORATORIES LIMITED IN 500 055 Hyderabad	R1-CEP 2010-228-Rev 01	19/06/2017	VALID	/	Chemistry
Citalopram hydrobromide	IPCA Laboratories Limited IN 400 067 Mumbai	R1-CEP 2010-296-Rev 00	08/12/2016	VALID	/	Chemistry
Citalopram hydrobromide	AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad	R1-CEP 2009-043-Rev 01	18/12/2017	VALID	/	Chemistry
Citalopram hydrobromide	DR. REDDY'S LABORATORIES LIMITED IN 500 034 Hyderabad	R1-CEP 2009-304-Rev 01	22/05/2017	VALID	/	Chemistry
Citalopram hydrobromide DGR process	JUBILANT GENERICS LIMITED IN 571 302 Nanjangud	R1-CEP 2010-379-Rev 01	10/06/2016	VALID	/	Chemistry
Citalopram hydrobromide	MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad	R1-CEP 2009-016-Rev 02	08/02/2019	VALID	/	Chemistry
Citalopram hydrobromide	CIPLA LIMITED IN 400 013 Mumbai	R1-CEP 2009-012-Rev 01	08/02/2018	VALID	/	Chemistry
Citalopram hydrobromide	H. Lundbeck A/S DK 2500 Valby	R1-CEP 2010-222-Rev 00	27/01/2017	VALID	/	Chemistry
Citalopram hydrobromide	NATCO PHARMA LIMITED IN 500 034 Hyderabad	R1-CEP 2009-390-Rev 01	14/02/2017	VALID	/	Chemistry
Citalopram hydrobromide	WUXI JIDA PHARMACEUTICAL CO., LTD. CN 214 445 Jiangyin	R1-CEP 2011-214-Rev 00	14/09/2017	VALID	/	Chemistry
Citalopram hydrobromide	HETERO DRUGS LIMITED IN 500 018 Hyderabad	R1-CEP 2009-248-Rev 02	26/09/2019	VALID	/	Chemistry
Citalopram hydrobromide CTP Process	HETERO DRUGS LIMITED IN 500 018 Hyderabad	R1-CEP 2012-120-Rev 02	14/10/2019	VALID	/	Chemistry
Citalopram hydrobromide	JUBILANT GENERICS LIMITED IN 571 302 Nanjangud	R1-CEP 2009-175-Rev 03	23/06/2021	VALID	/	Chemistry

Producer:Zhejiang Huahai Pharmaceutical Co., Ltd.was founded in 1989 and headquartered in Zhejiang, China. The company has nearly 7000 employees and more than 40 subsidiaries around the world (including China, the United States, Japan, Germany, etc.As a leading enterprise in the internationalization of Chinese medicine, Huahai pharmaceutical is the first pharmaceutical company in China to pass the FDA preparation quality certification and independently own the Anda document number. It is also the first Chinese pharmaceutical company to realize large-scale preparation sales in the United States. It has established China's pharmaceutical quality image in the world's high-end pharmaceutical market.

Staff size:About 7000 persons

Registered capital:RMB 1 billion 492 million

Producer:Wuxi Jida Pharmaceutical Co., Ltd., a wholly-owned subsidiary invested by Kunming Jida Pharmaceutical Co., Ltd. in Jiangsu, was established in June 2005. Wuxi Jida Pharmaceutical Co., Ltd. is committed to developing cutting-edge generic chemical APIs that meet the requirements of the United States and EU countries, with the goal of building an international pharmaceutical raw material base. The company regards product quality as the foundation of enterprise survival and development. While obtaining China GMP certification, the company actively applies for high-end market certification such as FDA and COS in Europe.
Staff size:100-199 persons

Registered capital:RMB 73 million

Producer:Sichuan Kelun Pharmaceutical Co., Ltd., subordinate to Kelun group, was successfully listed on Shenzhen Stock Exchange in June 2010.

Sichuan Kelun Pharmaceutical Co., Ltd. is a core manufacturer and a leading large-capacity injection production base in China. The company has 568 varieties of 981 specifications of pharmaceutical products, including 124 varieties of 292 specifications of infusion products, 393 varieties of 636 specifications of other dosage forms of pharmaceutical products, 51 varieties of 53 specifications of API. In addition, the company has 10 varieties of antibiotic intermediates and 4 varieties of medical devices with 7 specifications. The drugs produced by the company are classified according to the scope of clinical application, with a total of 25 dosage forms and 568 kinds of drugs.

Staff size:About 20000 persons

Registered capital:RMB 1 billion 425 million

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

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

Citalopram Hydrobromide

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