Clemastine Fumarate

CAS number： 14976-57-9

Molecular formula： C21H26ClNO.C4H4O4

molecular weight： 459.97

Chemical structure：

Producers shown on SFDA

(Record date:18/10/2021）

Producer	Documents	GMP Valid till(based on SFDA)
Jinan Gaohua Pharmaceutical Co., Ltd.	GMP	Valid till March 2020
Shandong Keyuan Pharmaceutical Co., Ltd.	GMP	Valid till July 2024
Penglai Nuokang Pharmaceutical Co., Ltd.	GMP	Valid till November 2019

Producers shown on EP

(Quoted from EP website；record date:18/10/2021）

Substance	Certificate Holder	Certificate Number	Issue Date	Status	End date	Type
Clemastine fumarate	SEKISUI MEDICAL CO., LTD. Tokyo JP	R1-CEP 2001-262 - Rev 04	17/02/2017	Valid	/	Chemical

Producer:Jinan Gaohua Pharmaceutical Co., Ltd., formerly known as Jinan Gaohua pharmaceutical factory, was founded in 1992. The new company covers an area of 16666.66 square meters, and the construction area of plant facilities is 6600 square meters, including 2260m2 oral solid preparation workshop, 2000m2 API workshop, 1200m2 warehouse, 600m2 office building, 920m2 public supporting facilities and 320m2 testing center. The greening area of the plant area accounts for 53% of the total area, The plant layout and environment meet GMP requirements.

Staff size:50-99 persons

Registered capital:RMB 2.1 million

Producer:Shandong Keyuan Pharmaceutical Co., Ltd. is a national high-tech enterprise, a core member enterprise of Linuo group's health industry and a backbone enterprise of chemical synthetic drugs in Shandong Province. It is committed to the R & D, production and sales of chemical API products and the development of China's pharmaceutical industry

The development of international high-end CMO / cdmo business has established strategic partnership with many well-known international enterprises.

In February 2016, Keyuan pharmaceutical was successfully listed in the National SME share transfer system,

At present, the company has obtained the domestic GMP certificate and the EU CEP certificate with international top certification, and has passed the international official certification of the United States FDA, Canada, Japan, South Korea and so on. The company has a relatively perfect production and R & D system. The production plant is located in the development zone of Shanghe County, Jinan, covering an area of more than 200 acres

Staff size:About 400 persons

Registered capital:RMB 58 million

Producer:Penglai Nuokang Pharmaceutical Co., Ltd. was established in 2002, with a total area of 69 thousand square meters. It has a modern R & D center laboratory with 41 thousand square meters and more than 1100 square meters in line with the requirements of the national GMP, and 7 production workshops. It has freeze-dried powder injection, small volume injection, tablet, granule, hard capsule, aerosol, spray. The scale production capacity of 12 modern production lines such as chemical raw materials and biochemical raw materials and more than 70 production varieties of various dosage forms, with an annual production of 72 million lyophilized powder injections and 45 million small volume injections; There were 250 million tablets, 50 million granules, 40 million capsules, 6 million aerosol and 6 million bottles of sprays.

Staff size:200-299 persons
Registered capital:RMB 92.7117 million

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

Clemastine Fumarate

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