Marksans Pharma announced that it has received final approval from US Food and Drug Administration for its abbreviated new drug application (ANDA) of Famotidine tablets, 10 mg and 20 mg, for over the counter (OTC) use.
The approved ANDA is bioequivalent to the reference listed drug (RLD), Pepcid AC tablets, a registered trademark of Johnson & Johnson Consumer Inc, which has sales of over $200 million in the US market.OTC Famotidine tablets are acid reducers which used to treat conditions where reduction of stomach acid is needed, such as acid indigestion, occasional heartburn, or sour stomach from eating or drinking certain foods or beverages.
Mark Saldanha, managing director of Marksans Pharma, said, We are delighted to continue OTC gastro portfolio expansion for our customers and it will help us to fulfill an important therapy gap created in Antacids market due to Ranitidine withdrawal.
Marksans Pharma is primarily engaged in the business of research, manufacture, marketing and sale of pharmaceutical formulations.
The company's consolidated net profit rose 31.4% to Rs 63.41 crore on 32.3% jump in net sales to Rs 479.83 crore in Q3 FY23 over Q3 FY22.
The scrip rose 0.41% to Rs 67.97 on the BSE.
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