After receiving a response from Panacea Biotec in March 2020 over Form 483 observations stemming from a February inspection, the FDA has gone ahead and issued a warning letter to the company relating to its manufacturing facility based in Himachal Pradesh, India, citing two key cGMP violations.

The deal would include an option for expansion to 160 million doses of the mRNA-based vaccine.

Zydus Cadila expects domestic sales to improve and the US generics business to grow in “mid to high” single digits during FY21 after both saw a coronavirus-related hit in Q1. Meanwhile, approvals for a few biologics are expected, its COVID-19 vaccine candidate has just entered Phase II studies and the firm has just launched its Remdac version of remdesivir.

Zydus Cadila expects domestic sales to improve and the US generics business to grow in “mid to high” single digits during FY21 after both saw a coronavirus-related hit in Q1. Meanwhile, approvals for a few biologics are expected, its COVID-19 vaccine candidate has just entered Phase II studies and remdesivir launch looms.