Bio-Medicinecc

Recently, Vazyme has successfully completed the FDA DMF filings of mRNA in vitro transcription related enzyme raw materials (the filing number is shown in the following table). Other raw materials have also applied for a reserved number, and will be active this year.Hereafter, customers using Vazyme related products will only need to directly quote DMF filing information when submitting drug applications to FDA, instead of providing specific information about raw materials and auxiliary materials in the application process. So as to simplify the review process , and improve the approval efficiency.

DMF Filing products：

Synthesis of mRNA in vitro transcription/in vitro co-transcription

• Synthesis of high-fidelity mRNA

• Meet the GMP quality system

• No animal source. No ampicillin process

• Capacity supplies 100 million vaccines

The DMF filing proves that Vazyme's production process and quality control system have met international standards and regulatory requirements, and also provides more protection and convenience for all Vazyme customers' research and clinical applications. Vazyme will continue to adhere to provide customers with high-quality and reliable mRNA raw materials products and services. And we’ll also continuously strengthen all aspects of product research and development, GMP production quality release and service, and fully support the demand for raw materials in the development, validation, application and other stages of mRNA vaccines/drugs.

Product List-For IVT