Producers shown on SFDA
(Record date:25/08/2021）
Producer | Documents | GMP Valid till(based on SFDA) |
Shandong New Time Pharmaceutical Co., Ltd.
| GMP, DMF | Valid till August 2022
|
Hebei Yipin Pharmaceutical Co., Ltd.
| GMP
| Valid till September 2022
|
Handan Fuhua Traditional Chinese Medicine Granules Co., Ltd.
| GMP
| Valid till August 2019
|
Shandong Keyuan Pharmaceutical Co., Ltd.
| GMP
| Valid till May 2024 |
Producers shown on EP
Not showing any
Producer:Shandong New Time Pharmaceutical Co., Ltd. is a member enterprise of Lunan Pharmaceutical Group. It is a national key high-tech enterprise. It was founded on March 23, 2002. It has more than 4000 employees. The overall planning covers an area of 8600 Mu and the planned investment is 10 billion yuan. It is mainly engaged in the R & D and production of traditional Chinese medicine, western medicine, chemical raw materials, preparations, antibiotics, biopharmaceutical and genetic engineering.
The enterprise has established a quality assurance system in line with international quality supervision concepts such as ICH, FDA and EDQM. All dosage forms and varieties have passed the new national GMP certification and won the title of "the best industrial enterprise in China's pharmaceutical R & D product line" for many times. The overall quality management level ranks in the forefront of the same industry in the country.
Staff size:4000-4990 persons
Registered capital:RMB 363.908 million
Producer:Hebei Yipin Pharmaceutical Co., LTD. is a modern high-tech pharmaceutical company that incorporates independent research & production, manufacturing and market operations. It was established in 2013 with around 2 billion RMB investment, and now have more than 300 staff members.
The predecessor of Hebei Yipin Pharmaceutical Co., LTD. is a pharmaceutical factory of Hebei Provincial Institute of Pharmaceutical Studies which is established in 1988, it was the first factory in China to manufacturing inhalational anesthetics for general anaesthesia. At the same year, the company was awarded Hebei provincial Excellent New Technology First Prize for “The research and manufacturing technology of inhalational anaesthetics”.
The company has five production lines right now including water injections, lyophilisation, suspension of liquid (inhalational anesthetic), combination (APIs) and pilot scale production, all five production lines have been certified by GMP.
Staff size:300-399 persons
Registered capital:RMB 68.68 million
Producer:Handan Fuhua Traditional Chinese Medicine Granules Co., Ltd. was founded in 1996. It is located in Matou ecological industrial city, Handan city. It is adjacent to national highway 107 and expressway in the East. The transportation is very convenient. The total investment is more than 5 million yuan. The plant covers an area of 3000 square meters and produces more than 250 varieties. It has more than 10 years of historical experience in processing traditional Chinese medicine decoction pieces, capable team management and modern production, With scientific inspection instruments, it passed the GMP certification of the State Food and Drug Administration in 2007. The company's purpose is "people-oriented, honest management and quality first". It is willing to establish partnership with new and old customers from all walks of life, frank cooperation, mutual benefit, common development and create brilliance.
Staff size:About 500 persons
Registered capital:RMB 5 million
Producer:Shandong Keyuan Pharmaceutical Co., Ltd. is a national high-tech enterprise, a core member enterprise of Linuo group 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 international high-end CMO / cdmo business, and has established strategic partnership with many international well-known 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 mu. The company has a provincial recognized enterprise technology center, a municipal postdoctoral innovation practice base, and a professional and international R & D team.
Staff size:About 400 persons
Registered capital:RMB 58 million
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