FDAnews Drug Daily Bulletin

Cempra Drug Stalled Over Wockhardt Manufacturing Concerns

Nov. 10, 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.

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