Good news! Hubei Gedian Renfu Accessories Products Won DMF Archive Number Again

This month, our company received a DMF filing confirmation letter from FDA, informing us that four products of our company have successfully obtained DMF filing numbers, namely:

Trehalose (Trehalose)DMF Filing Number: 035711

Caprylic acid monoglyceride (Mono and Dicaprylocaprate Glyceryl)DMF Filing Number: 036199

Squalene (Squalene)DMF Filing Number: 036346

Sucrose (Scurose)DMF Filing Number: 036348

Trehalose (Trehalose)Known as the "sugar of life", it has better physical and chemical properties than glucose and maltose. Its safety has already passed the certification of the United States and the European Union and entered the international market. The FDA filing number confirms that our trehalose products have reached the level of international certification in terms of quality control, process technology and safety, and can occupy a place in the international market.

Caprylic acid monoglyceride (Mono and Dicaprylocaprate Glyceryl)It consists of glyceryl mono-O-caprylate and glyceryl mono-O-caprate in different proportions and contains different amounts of diglycols and triglycols. It is a new type of oily glyceride pharmaceutical excipients, which has a good solubilization effect on insoluble drugs and has been used in many listed pharmaceutical preparations. This variety has been collected in the United States Pharmacopoeia and European Pharmacopoeia. Our company has completed the Sino-US double report of this product, which can provide more choices for domestic and foreign preparation manufacturers.

Squalene (Squalene)It is a unique active nutrient thirty carbon six alkene, which can improve the activity of superoxide dismutase in the body, enhance the body's immune ability, anti-fatigue, anti-aging, anti-tumor and other physiological effects, at the same time, squalene as a vaccine adjuvant, can improve the effectiveness of the new crown vaccine, is an efficient medical substance. The Sino-US double report on squalene has been completed, providing more possibilities for our company to open up the international market.

Sucrose (sucrose)The chemical properties are stable, mostly amorphous structure, which plays a significant role in preventing the change of protein secondary structure and the stretching and aggregation of protein during the freeze-drying process and storage period. Its higher glass transition temperature can better maintain the structure of protein molecules. At the same time, it has superior water displacement characteristics than other polyols. Sucrose as a pharmaceutical excipient in the pharmaceutical industry, on the one hand, it can reduce the interference and effect of the main raw material drug, extend the shelf life of the drug, and achieve easy control and control of drug quality. On the other hand, reducing the content of impurities is to reduce the damage to people's health. Completion of the FDA declaration, so that our products are no longer limited to the domestic market.

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