Sun Pharma gets approval from China NMPA for NDA of tildrakizumab injection

31 May 2023 Evaluate

Sun Pharmaceutical Industries has received an approval for the New Drug Application (NDA) of tildrakizumab injection under the brand name of ILUMETRI from the National Medical Products Administration of the People’s Republic of China (China) (NMPA). ILUMETRI is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

In June 2019, Sun Pharma out-licensed tildrakizumab to a subsidiary of China Medical System Holdings (CMS), for development, regulatory filings and commercialisation of the product in Greater China. Tildrakizumab Injection has also been approved for marketing in the US, EU, Japan, UK, Switzerland, Canada, Australia, Hong Kong and other countries/regions under the brands of ILUMYA and ILUMETRI in different geographies.

Sun Pharmaceutical Industries is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.


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