The inspection was conducted from February 13 - 20 and February 24-25, 2020. Three products have been exempted from the Import Alert - azacitidine for injection, cyclophosphamide capsules and erlotinib tablets.
In October 2020, the company had received a warning letter from the US drug regulator for its Jadcherla, Telangana facility.
Shilpa Medicare is a global brand in manufacturing and supplying of affordable API and formulation globally in different regulated markets.