Hospira's Indian plant cleared by US FDA

US sterile generics and biosimilars maker Hospira (NYSE: HSP) says its Indian subsidiary has received official notification from the US Food and Drug Administration that the inspection of the Visakhapatnam, India facility (the “Vizag facility”) was deemed acceptable for the manufacture of finished dosage drugs.

As a result of this action, the company may receive US product approvals from this facility in the future, said Hospira in a filing with the Securities and Exchange Commission. Hospira is currently the subject of an around $17 billion takeover deal from US pharma giant Pfizer (NYSE: PFE).

As was previously reported, the FDA conducted a pre-approval inspection of the Vizag facility from February 16 to February 25, 2015, which resulted in the issuance of a Form 483 containing 14 observations. Hospira responded to the Form 483 on March 18, 2015, and submitted additional support documentation on May 29, 2015.