www.fdanews.com/articles/179210-cempra-drug-stalled-over-wockhardt-manufacturing-concerns
Cempra Drug Stalled Over Wockhardt Manufacturing Concerns
November 9, 2016
The FDA is holding up approval of Cempra’s pneumonia drug Solithera (solithromycin) because of a ban of Wockhardt, its India-based API supplier.
Wockhardt has been sanctioned by the FDA twice this year. In June, Wockhardt received a Form 483 that cited nine cGMP violations, and in October the FDA banned all imports from a Wockhardt plant in India, putting it on the agency’s import alert list.
Cempra has stated that it is currently working with a new supplier to increase production in anticipation of a commercial launch.