Marksans Pharma Limited has informed the Exchange regarding a press release dated August 08, 2025, titled "Marksans Pharma Limited s wholly owned subsidiary Marksans Pharma Inc. receives USFDA approval for Omeprazole Delayed-Release Tablets, 20 mg (OTC).".
MARKSANS · price
▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.
Awaiting price reaction for this filing.
Marksans Pharma's wholly owned US subsidiary, Marksans Pharma Inc., has received final USFDA approval for its Abbreviated New Drug Application (ANDA) for Omeprazole Delayed-Release Tablets, 20 mg (OTC). The product is bioequivalent to AstraZeneca's Prilosec OTC tablets. Omeprazole is a widely used over-the-counter treatment for heartburn and excess stomach acid conditions. This approval allows Marksans to market and sell this generic OTC product in the United States through its US-based subsidiary.
Positive for shareholders — adds a new generic OTC product to Marksans' US portfolio, potentially boosting revenue from the US market where the company already operates through its subsidiary. However, the financial impact may be modest as Omeprazole is a mature, highly competitive generic segment.