Recently, Topscience Biotech have passed the DMF registration and on-site GMP verification of Sodium Hyaluronate by Korean Ministry of Food and Drug Safety, and once again obtained the Certificate of DMF Registration from Korea!

Our company conducted several studies and preparations with the requirements of the Korean Ministry of Food and Drug Safety authority, always adhere to high standards and strict requirements, which took three years to complete. We completed the optimization of the production process of Sodium Hyaluronate API, exploration of physical and chemical properties, analysis of impurity files, stability research, etc, and successfully passed the on-site inspection.

This achievement marks the further recognition of our Sodium Hyaluronate API in the Korean pharmaceutical market and represents an important step in expanding into the overseas market. In the future, Topscience Biotech will continue to expand its business and offer superior quality, safe and compliant raw materials to help each partner achieve their differentiated competition globally.

Diversified product matrix

In the pharmaceutical and medical field, it includes pharmaceutical series (Injection grade sodium hyaluronate, Eye-drop grade sodium hyaluronate, Excipient grade sodium hyaluronate), medical series (Medical grade I sodium hyaluronate, Medical grade M sodium hyaluronate, Medical grade S sodium hyaluronate, Medical grade T sodium hyaluronate, Medical grade chondroitin sulfate sodium ), to meet different pharmaceutical and beauty needs.  At the same time, we are also actively developing a variety of new pharmaceutical raw materials, which will provide more high-quality and innovative choices for global partners.

Safe and reliable product quality

Topscience Biotech’s products are made from microbial fermentation and non-animal raw materials. They are characterized by ultra-low impurity, ultra-low bacterial endotoxin, ultra-low element impurity residue, ultra-low microbial limit control and sterility inspection items meeting the requirements. It covers all molecular segments of large, medium and small weight, and can be used for various medical purposes.

Comprehensive and systematic quality certification

Topscience Biotech has more than 20 global authoritative certifications and has successfully passed GMP certificate, certificate of Suitability to Monograph of European Pharmacopeia, Certificate of KDMF Registration, Certificate of Form 41 Registration, Food and Drug Administration and Accreditation certificate of foreign drug manufacturer. In addition, we have obtained Written confirmation for active substances exported to EU and have Kosher, Halal, COSMOS and ECOCERT certifications. These qualifications demonstrate our credibility and strength in the international market.