Alembic Pharmaceuticals received tentative approval from the US FDA for Empagliflozin and Metformin Hydrochloride tablets that are used for management of type-2 diabetes. This generic version is clinically equivalent to the Synjardy tablets manufactured by Boehringer Ingelheim. Alembic Pharma is currently in litigation with Boehringer Ingelheim.

These 2 tablets are an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus. They jointly have an annual market size of $172 million. With this latest approval, Alembic Pharma now has 126 ANDA approvals from the USFDA. The process of approvals for Indian pharma companies has speeded up after COVID-19.