Aurobindo arm Lannett’s facility in U.S. gets 4 U.S. FDA observations

The U.S. Food and Drug Administration (FDA) has issued four observations to Lannett Company LLC, a U.S. subsidiary of Aurobindo Pharma, following a routine inspection of its manufacturing facility in Seymour, Indiana.

The inspection was conducted from August 17 to 21 and concluded with four observations, which the company described as procedural in nature. Aurobindo Pharma said it has responded to the observations within the stipulated timeline and remains committed to maintaining robust quality and compliance standards across its manufacturing facilities.

In June, Aurobindo Pharma announced that it had received approval from the U.S. Federal Trade Commission (FTC) for its $250 million acquisition of Pennsylvania-based Lannett. The company said Lannett specialises in developing and commercialising a diversified portfolio of complex, non-opioid controlled substances.

Lannett’s Seymour manufacturing facility has the capacity to scale production to approximately 4 billion doses annually.