The FDA has revealed details of its recent warning letter to Shilpa, which cites the company’s failure to adequately investigate out-of-specification results and complaints as well as to follow written procedures for complaint handling.

Pfizer has reported 80% growth in its global biosimilars business for the third quarter of 2020, on the back of recent oncology launches. Though the company’s sterile injectables saw a slight drop in business, Pfizer’s biopharma business saw 4% growth.

The FDA’s generic drug program yearly performance report shows that generic drug approvals declined for the first time in five years in fiscal year 2020, and the agency also reported a lower number of ANDA submissions.