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Qianhui Biotechnology
Zibo Qianhui Biotechnology Co., Ltd., founded in 2006 and located in Polymer Industrial Park in Zibo High-tech Zone, is a high-tech enterprise integrating scientific research, production and sales.
The company specializes in production of pharmaceutical excipients, food and cosmetic additives that consist mainly of cyclodextrin and its derivative. Sulfobutyl ether beta cyclodextrin sodium, a new injectable excipient independently researched and developed by the company, is the first new excipient (registered as “A”) passing technical review with associated drug product and fills in the market gap in China. CDE platform - pharmaceutical excipient registration No.: F20180000620, U.S. FDA registration No.: DMF 29394. Hydroxypropyl-beta-cyclodextrin, CDE platform - pharmaceutical excipient registration No.: F20209990335 (oral administration, activated, Lu Yao Zhun Zi F2012004), F20180000146 (oral administration) and F20180000895 (injection), U.S. FDA registration No.: DMF 033403. It has been widely applied and approved in domestic and foreign markets.
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LEADER OF CYCLODEXTRIN
Business Advantage
LEADER OF CYCLODEXTRIN
The company specializes in production of pharmaceutical excipients, food and cosmetic additives that consist mainly of cyclodextrin and its derivative. Sulfobutyl ether beta cyclodextrin sodium, a new injectable excipient independently researched and developed by the company, is the first new excipient (registered as “A”) passing technical review with associated drug product and fills in the market gap in China. CDE platform - pharmaceutical excipient registration No.: F20180000620, U.S. FDA registration No.: DMF 29394. Hydroxypropyl-beta-cyclodextrin, CDE platform - pharmaceutical excipient registration No.: F20209990335 (oral administration, activated, Lu Yao Zhun Zi F2012004), F20180000146 (oral administration) and F20180000895 (injection), U.S. FDA registration No.: DMF 033403. It has been widely applied and approved in domestic and foreign markets.
Technological Innovation
Adhering to the concept of treating product quality as enterprise life, the company enhances risk management and sets up and completes the quality management system as per the requirements of GMP.
1. Set up a complete quality management system based on the concept of risk management to control the whole production process.
2. Implement GMP for pharmaceutical excipients and medical products actively.
3. Carry out validation of production process and key production equipment.
4. Implement quality authorized person system and release products by the authorized person.
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