Cadila Gets Five Observations From U.S. FDA For Arm’s Injectables Unit
Cadila Healthcare Ltd. said the U.S. health regulator has issued five observations after inspection of its subsidiary Liva Pharmaceuticals' injectables manufacturing facility.
"This was a product specific pre-approval inspection. It concluded with five observations. Liva will respond to U.S. FDA within 15 days. It may be noted that at present Liva doesn't export products to the US market," Cadila Healthcare said in a filing to BSE.
The injectables facility is located at Vadodara.
The United States Food and Drug Administration conducted the inspection from August 20-28. Liva is a 100 percent subsidiary of Cadila Healthcare.
Shares of Cadila Healthcare fell 2.86 percent to Rs 386 apiece on the BSE.