Mumbai, July 22 -- The approval follows a GMP inspection conducted by ANVISA from 11 May to 15 May 2026. The inspection covered the facility's biological API and sterile product manufacturing operations.

The scope of the inspection included four biosimilar products and assessed the mammalian and microbial drug substance manufacturing facility, prefillable syringe and vial filling facility, packaging and labelling operations, as well as quality control testing and release laboratories.

The company said CuraTeQ's drug substance and drug product GMP facility is already certified by the European Medicines Agency (EMA) and the World Health Organization (WHO). The ANVISA approval further strengthens the company's regulatory credentials and en...