In April this year, the United States Food and Drug Administration (US FDA) had conducted a current Good Manufacturing Practices (cGMP) inspection at the manufacturing facility of Time-Cap Laboratories, Inc. located at Michael Avenue, Farmingdale, New York, USA. The inspection was conducted between 16th and 24th of April 2025.
Post the said inspection, the American drug regulator had issued one inspectional observation in Form 483. There was no data integrity observation.
In a regulatory filing made during market hours today, Marksans Pharma stated that Time-Cap Laboratories has received the establishment inspection report (EIR) from the US FDA for the said facility.
Marksans Pharma is engaged in research, manufacturing & marketing of generic pharmaceutical formulation in the global markets. The company's manufacturing facilities located in India, USA and UK are approved by several leading regulatory agencies, including USFDA, UKMHRA and Australian TGA. The company's robust product portfolio spreads over major therapeutic segments of CVS, CNS, anti-diabetic, pain management, gastroenterological, and antiallergic. The company is marketing these products globally.
The company reported a 15.7% increase in consolidated net profit to Rs 90.55 crore on a 26.5% rise in revenue from operations to Rs 708.46 crore in Q4 FY25 over Q4 FY24.