Marksans Pharma Ltd announces US FDA approval for Pregabalin Capsules

Marksans Pharma Limited (Reuters: MARK.BO; Bloomberg: MRKS IN; NSE: MARKSANS; BSE: 524404) has received final approval from US Food & Drugs Administration for its Abbreviated New Drug Application (ANDA) for Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg.

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Lyrica Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg, of Upjohn US 2 LLC.

Pregabalin capsules (RLD Lyrica) had estimated annual sales of USD 263 million in the U.S. (IQVIA MAT March 2022).

Shares of Marksans Pharma Limited was last trading in BSE at Rs. 49.25 as compared to the previous close of Rs. 49.35. The total number of shares traded during the day was 90897 in over 823 trades.

The stock hit an intraday high of Rs. 49.70 and intraday low of 49.05. The net turnover during the day was Rs. 4478864.00.

Source : Equity Bulls

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MarksansPharma INE750C01026 USFDA ANDA Approval PregabalinCapsules