Mylan's Lantus copy derailed in U.S. again by manufacturing ills

Mylan's Lantus copy derailed in U.S. again by manufacturing ills

Source: 
Fierce Pharma
snippet: 

When Biocon’s insulin operations in Malaysia won EU approval, the company turned a quality corner. But that turn is not sharp enough for the FDA, which issued a second complete response letter for the Lantus competitor Biocon developed with Mylan.