Caplin Point Laboratories Ltd. on Thursday informed exchanges that the US Food and Drug Administration (USFDA) issued four observations on the sterile injectable site of its subsidiary Caplin Steriles Ltd.
The observations were followed by the US drug regulator’s goods manufacturing practice (GMC) and pre-approval inspection (PAI) at Caplin Steriles’ injectable site at Gummidipoondi between May 22 and 31.
The company, however, said, “These observations are procedural in nature and the corrective and preventive actions for these observations will be presented to the USFDA within the stipulated period.”
‘Not repeat observations’
Caplin Point Laboratories has manufacturing facilities in Puducherry, Chennai, and Himachal Pradesh while Caplin Steriles has a plant in Gummidipoondi near Chennai for handling sterile injectable and ophthalmic dosages catering mainly to the US market.
In 2017, it first got USFDA approval for the liquid injectable facility. Till date, the injectable plant has gone through three US FDA and two European Union GMP audits since 2015. In October 2016 and June 2019, the USFDA made two observations of procedural nature.
On Thursday’s filing, the company added that the observations made were not repeat observations or related to data integrity.
Shares of Caplin Point were trading at ₹754.60 apiece on NSE against the previous day’s closing price of ₹747.60 per share.