Alembic Pharma's injectables plant launch may face some delay

Company saw Form 483 with observations issued by US FDA for injectables plant in February

Vadodara-based Alembic Pharmaceuticals Ltd might see three to six months of delay in the launch of its new injectables plant after receiving Form 483 with observations from the US Food and Drug Administration (US FDA).

The company had been waiting for US FDA inspection for F2, F3 and F4 plants which will manufacture oncology injectables and oral solid dosages (OSDs), general injectables and general OSDs specifically for the regulated US market. While there is so far no clarity on inspection for oncology injectables and OSDs plant as well as general OSDs plant, the general injectables plant saw USFDA issue form