Aurobindo Pharma receives USFDA Approval for Dextromethorphan Polistirex ExtendedRelease Oral Suspension, 30 mg/5 mL (OTC)

Aurobindo Pharma Limited is pleased to announce the receipt of the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Aurobindo Pharma receives USFDA Approval for Dextromethorphan Polistirex Extended-Release Oral Suspension, 30 mg/5 mL (OTC), which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Delsym ExtendedRelease Oral Suspension, 30 mg/5 mL, of RB Health (US) LLC.

The product will be manufactured at Unit-IV of APL Healthcare Limited, a wholly owned subsidiary of the company, and will be launched in Q2FY27.

The approved product has an estimated market size of US$ 138 million for the twelve months ending February 2026, according to Nielsen. Aurobindo Pharma now has a total of 580 ANDA approvals (557 final approvals and 23 tentative approvals) from USFDA.

Dextromethorphan Polistirex Extended-Release Oral Suspension (OTC) temporarily relieves (1) cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants (2) the impulse to cough to help one get to sleep.

Shares of Aurobindo Pharma Limited was last trading in BSE at Rs. 1385.65 as compared to the previous close of Rs. 1386.10. The total number of shares traded during the day was 24210 in over 1587 trades.

The stock hit an intraday high of Rs. 1394.10 and intraday low of 1376.80. The net turnover during the day was Rs. 33554305.00.

Source : Equity Bulls

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AurobindoPharma INE406A01037 Pharmaceuticals USFDA Approval