Caplin Point Laboratories said that the United States Food and Drug Administration (US FDA) had completed its good manufacturing practices (GMP) and pre-approval inspection (PAI) inspection of Caplin Steriles' injectable site at Gummidipoondi, Thiruvallur district, Tamil Nadu. The inspection was carried out from 22nd to 31st of May 2023.
At the end of the inspection, there were four observations by US FDA. These observations are procedural in nature and the corrective and preventive actions for these observations will be presented to the US FDA within the stipulated period.
The observations made were not repeat observations or related to data integrity.
Caplin Steriles is a subsidiary of Caplin Point Laboratories.
Caplin Point Laboratories is engaged in the business of pharmaceuticals - producing, developing and marketing wide range of generic formulations and branded products and exporting to overseas market.
The company reported 29.16% increase in consolidated net profit to Rs 102.11 crore on a 14.75% increase in sales to Rs 389.28 crore in Q4 FY23 over Q4 FY22.
The scrip rose 0.58% to currently trade at Rs 761 on the BSE.
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