Strides is expanding its presence in synthetic injectables via a new company, SteriScience, while keeping its biologics injectables business under Stelis. A head start with existing IP assets and those from a new joint venture with Brooks Labs will enable the fledgling firm to file its first ANDA in fiscal 2021, with break-even foreseen in two years.

Strides is expanding its presence in synthetic injectables via a new company, SteriScience, while keeping its biologics injectables business under Stelis. A head start with existing IP assets and those from a new joint venture with Brooks Labs will enable the fledgling firm to file its first ANDA in fiscal 2021, with break-even seen in two years.

Concerned about another possible nitrosamine scare, the US FDA has sent a warning letter to Mylan focusing on the firm’s failure to control contamination risks of its APIs and inadequate testing of reused solvents.

Concerned about another possible nitrosamine scare, US FDA warning letter to Mylan focuses on firm’s failure to control contamination risks of its APIs and its inadequate testing of reused solvents.