Summary of American DMF Archive Number of Varieties of Gerdianfu Medicine Auxiliary Accessories in Ge Dian

Ge Dian Renfu Pharmaceutical Auxiliary Accessories Varieties United StatesDMFSummary of Filing Number

At present, Hubei Gedian Renfu Pharmaceutical Accessories Co., Ltd. has4varietiesS. Food and Drug Administration (hereinafter referred to“FDA”）DMFFiling number,Include

Polysorbate for Injection80(Polysorbate 80(For Injection))

Benzalkonium chloride (Benzalkonium Chloride）

Ethyl paraben (Ethylparaben）

Hydroxyphenyl butyl ester (Butylparaben）

4The application status of all varieties has been"A”（Active）。

Polysorbate for Injection80is the firstDMFThe archive number is"A"Status and in line with Chinese Pharmacopoeia (CP) standard products, respectively, can meet the domestic preparation enterprises in China and the United States double report and foreign enterprises import registration compliance. Authorization letters have been issued to many domestic and foreign customers (LOA), in multipleNDA,BLAandANDAThere are mature application cases in all of the products.

In the near future, the company will alsoFDASubmit refined sesame oil (Sesame Oil Refined), refined castor oil (Castor Oil Refined) and benzyl benzoate (Benzyl benzoate)DMFapplications to further expand the production line of oil and fat products,helpCompanyThe development of the international market has been recognized by international customers and further enhanced the international competitiveness of the company's products.