Cipla's US subsidiary InvaGen gets 5 inspectional observations from USFDA

In a regulatory filing on Wednesday, Cipla announced that the United States Food and Drug Administration (USFDA) had conducted an inspection at its wholly-owned subsidiary, InvaGen Pharmaceuticals, manufacturing facility in Central Islip, New York, USA, from September 11 to 19, 2023, receiving five inspectional observations in Form 483.

The inspection was a routine current Good Manufacturing Practices (cGMP) inspection and a Pre-Approval Inspection (PAI) for a site transfer product within InvaGen.

"The company will work closely with the USFDA and is committed to addressing these comprehensively within a stipulated time," Cipla stated in its filing.

In May 2023, at the same manufacturing facility, Cipla had announced that the USFDA had completed an inspection with zero observations.

Cipla acquired InvaGen Pharmaceuticals and Exelan Pharmaceuticals in 2015 for $550 million. InvaGen Pharmaceuticals is valuable to Cipla's portfolio as it offers a diverse range of products targeting both large and niche markets. This acquisition in 2015 further provided Cipla with access to large wholesalers and retailers in the US.

Cipla has been in the spotlight recently amid reports of its promoters exploring the sale of their stake in the company. Interested parties, including fellow drugmaker Torrent Pharmaceuticals, have been linked to these developments.