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Fudosteine

CAS number: 13189-98-5

Molecular formula: C6H13NO3S

molecular weight: 79.24

Chemical structure:

Producers shown on SFDA

(Record date:07/09/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Zhejiang Guobang Pharmaceutical Co., Ltd.

GMP
Valid till November 2024

HEC Pharmaceutical Co., Ltd.

GMP
Valid till May 2022

Weihai Disu Pharmaceutical Co., Ltd.

GMP
Valid till January 2022

Sichuan Xinkaiyuan Pharmaceutical Co., Ltd.

GMP
Valid till January 2023

Lianyungang Runzhong Pharmaceutical Co., Ltd.

GMP
Valid till February 2020

Topfond Pharmaceutical Co., Ltd.

GMP
Valid till January 2023


Producers shown on EP

Not showing any


Producer:Zhejiang Guobang Pharmaceutical Co., Ltd. is the core enterprise of Guobang enterprise group, mainly producing and operating pharmaceutical raw materials, chemical intermediates and veterinary drugs. The whole enterprise has passed ISO9001:2000 quality system and ISO14001 environmental quality system certification. All products are produced in strict accordance with ICH Q7A standards and have passed the domestic GMP certification. American DMF and European DMF, which have independently compiled drugs, have a production capacity and market share of more than 30% of similar products in China.

Staff size:1000-1999 persons

Registered capital:RMB 138.8 million


Producer:HEC Pharmaceutical Co., Ltd. formerly known as HEC Biochemical Pharmaceutical Co., Ltd., was established on January 12, 2004. It is a large-scale western medicine manufacturing and bioengineering enterprise mainly engaged in the R & D, production and sales of macrolide antibiotics, antiviral drugs, insulin and other drugs. At present, the company is the largest in the world It is a manufacturer of macrolide antibiotic API with the most advanced technology. Its main customers are pharmaceutical giants such as Abbott and Pfizer. It is also one of the earliest enterprises engaged in the R & D, registration and production of overseas generic drugs.

The company attaches great importance to the research and development of preparation technology, and has established a variety of preparation technology platforms such as slow and controlled release and transdermal technology. The company is also carrying out the layout of preparation products in Europe and America. At present, seven products have passed the EU cGMP certification, three products have passed the FDA certification, and macrolide APIs have passed the FDA cGMP certification.

Staff size:2000-2999 persons

Registered capital:RMB 813.368 million


Producer:The company is now deregistered.

Weihai Disu Pharmaceutical Co., Ltd., established in May 2005, is a subsidiary of Disha Pharmaceutical Group. It is a national high-tech enterprise integrating R & D, production and sales of chemical APIs, veterinary drugs, marine biological new materials and their intermediates.

Staff size:RMB 40 million

Registered capital:January 2022


Producer:Sichuan Xinkaiyuan Pharmaceutical Co., Ltd. is a wholly-owned subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd. Founded in 2000, it is the production base of Kelun group focusing on research, production and sales of API. Covering an area of more than 70 mu, the company mainly produces sugar and glycoside series, synthetic starch series, small peptide series, quinolones series and other synthetic chemical raw materials.

Staff size:300-399 persons

Registered capital:RMB 12 million


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:Topfond Pharmaceutical Co., Ltd.is a large-scale large-scale enterprise integrating the production and sales of finished products, chemical synthesis raw materials and biological fermentation raw materials, and pharmaceutical management. Comprehensive pharmaceutical company.

Topfond Pharmaceutical was founded in 1969. In December 2000, the A shares of Topfond  Pharmaceutical was listed on the Shanghai Stock Exchange. After more than 40 years of hard work, the company has grown from small to large, from weak to strong, and has now developed into a large pharmaceutical group with 5 subsidiaries, 4 production plants and 1 national technology development center. It has 4000 employees. There are more than 4 people with total assets of more than 4 billion yuan. The company's production scale of finished preparations and fermentation tonnage of antibiotic raw materials are among the best in the industry in the country. Joined China General Technology Group in August 2008. In July 2013, it successfully realized the merger and absorption of shares exchange with China National Pharmaceutical and Health Industry Co., Ltd., and was officially included in China Pharmaceutical Management.

Topfond Pharmaceutical produces and reserves more than 10 types and nearly 600 varieties and specifications of products. It has an oral solid preparation workshop with an annual production capacity of nearly 6 billion tablets (tablets), the scale is among the forefront of the industry; the antibiotic fermentation tonnage is 12,000m³. The raw materials and some preparation products are exported to more than 20 countries and regions including Western Europe, Southeast Asia, the Middle East, North Africa, India, etc., and an international marketing network is initially formed.

Staff size:2000-2999 persons

Registered capital:RMB 420 million


For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +8618402846978