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Imatinib Mesylate

CAS number: 220127-57-1

Molecular formula: C30H35N7O4S

molecular weight: 589.708

Chemical structure:

Producers shown on SFDA

(Record date:06/09/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Lianyungang Runzhong Pharmaceutical Co., Ltd.

GMPValid till April 2023

Jiangsu Hansoh Pharmaceutical Group Co., Ltd.

GMP
Valid till September 2023

CSPC Ouyi Pharmaceutical Co., Ltd. 

GMP
Valid till November 2022


Producers shown on EP

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Producer:Lianyungang Runzhong Pharmaceutical Co., Ltd., a wholly-owned subsidiary and API production base of Zhengda Tianqing Pharmaceutical Group, was established in 2010, covering an area of 206 mu. In 2012, it was recognized as a high-tech enterprise, mainly engaged in the R & D, production and sales of various chemical APIs.

At present, the company has 7 product production workshops, 4 pilot workshops for new products, 1 product development center, and 2 drug inspection centers, power workshops and warehouses. There are 52 products approved for listing in China, of which 16 are listed as high-tech products in Jiangsu Province, involving liver disease, tumor, cardiovascular, respiratory and other fields, with an annual production capacity of more than 100 tons.

With the continuous increase of product types and production scale, the economic benefits of the company have also increased year by year. In 2020, the sales revenue will reach 3.5 billion yuan, including 10 API products such as arotinib hydrochloride, magnesium isoglycyrrhizinate and Diammonium Glycyrrhizinate, forming a "product group with sales of more than 100 million". The company has passed FDA certification for "zero defect" twice, and 14 products passed GMP on-site inspection in 2020, indicating that the company's quality management is at a high level in the industry.

Staff size:1000-1999 persons

Registered capital:RMB 103 million 528 thousand and 805


Producer:Founded in 1995, Jiangsu Hansoh Pharmaceutical Group Co., Ltd.is a leading R &D-driven pharmaceutical company in China. The company was listed on the Hong Kong Stock Exchange in June 2019

We have set up effective in house sales force with therapeutic area focus and strong academic promotion capabilities. We have established world class facilities and a manufacturing quality management system that compares with the cGMP requirements in China,  the United States and Japan. Our manufacturing systems have obtained cGMP certifications from the U.S. FDA and the Japanese PMDA,  and we plan to leverage our strong track record and experience to obtain additional quality system certifications and adopt advanced standards for entries into overseas markets. Our manufacturing quality management system enables us to produce all of our pharmaceutical products and the majority of our active pharmaceutical ingredients (APIs) in-h ouse.

Staff size:9000-9999 persons

Registered capital:RMB 1 million


Producer:CSPC Ouyi Pharmaceutical Co., Ltd. is a listed enterprise under CSPC Pharmaceutical Group Co., Ltd.

The company has four pharmaceutical preparation production buildings designed according to GMP standards and four API production lines with international advanced level. The product dosage forms include small volume injection, powder injection, freeze-dried powder injection, tablet, hard capsule, soft capsule, granule, dry suspension, etc. The annual production capacity is: 9 billion tablets, 400 million hard capsules, 400 million soft capsules, 600 million bags of granules, 600 million small volume injections, 300 million powder injections and 200 million bags of dry suspensions. The product quality meets BP, USP, JP and EP standards respectively according to different requirements of customers. The company has passed the national GMP quality certification, "zero defect item" has passed the FDA certification of the United States, has also passed the MCC quality certification of South Africa, and many varieties have obtained the EU CEP certificate.

Staff size:4000-4999 persons

Registered capital:RMB 300 million


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