Ge Dian Renfu Medicine Auxiliary Natural Oil Accessories CDE Registration Summary

Recently, the sesame oil (for injection) products supplemented by Ge Dian Renfu Medicine have been registered on the CDE raw and auxiliary package registration platform. The production line layout of high-purity grade natural oil series products has been further expanded. At present, Ge Dian Renfu medicine auxiliarySesame oil (for injection), castor oil (for injection), peanut oil, sesame oil, soybean oilFive other natural oil varieties have been publicized on the platform.

The oil production technology independently developed by Gedian Renfu Pharmaceutical Auxiliary can accurately remove various impurities in natural oil through efficient, convenient and green means, including free fatty acids, peroxides, unsaponifiable substances, pigments, odor small molecules, etc., and control the acidity, peroxide value, color, odor and other key quality control indicators of natural oil auxiliary materials. The above products are all purified by the technology with independent intellectual property rights, and the final products are in line with the current mainstream pharmacopoeia standards (Chinese Pharmacopoeia 2020 Edition, USP41, EP10.0).

With the development of consistency evaluation of injections, Gedian Renfu Pharmaceutical Auxiliary focuses on the development of injection-grade natural oil and fat excipients, helping the research and development and declaration of domestic injections, and will continue to introduce various natural vegetable oil and fat excipients to meet the research and development and production needs of domestic and foreign preparation enterprises and provide more choices for preparation enterprises!

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