20 Apr , 2026 By : Debdeep Gupta
Shares of Aurobindo Pharma touched 52-week high of Rs 1,396.60 in the opening trade on April 21 but erased the gains and trading flat after the company received approval from the U.S. Food and Drug Administration for a cough syrup product.
At 09:23am, Aurobindo Pharma was quoting at Rs 1,378.70, down Rs 6.95, or 0.50 percent, on the BSE.
The approval is for Dextromethorphan Polistirex extended-release oral suspension (30 mg/5 mL, OTC). The product is bioequivalent and therapeutically equivalent to the reference listed drug Delsym Extended Release Oral Suspension, marketed by RB Health (US) LLC.
The formulation will be manufactured at Unit-IV of APL Healthcare, a wholly owned subsidiary of Aurobindo Pharma, with a planned launch in Q2 FY27.
Dextromethorphan Polistirex is used for the temporary relief of cough caused by minor throat and bronchial irritation, with the common cold or inhaled irritants and the impulse to cough to help one get to sleep.
In a separate development, the company has received final approval from the U.S. Food and Drug Administration to manufacture and market Glycerol Phenylbutyrate Oral Liquid (1.1 g/mL).
The product is bioequivalent and therapeutically equivalent to the reference listed drug Ravicti Oral Liquid, marketed by Horizon Therapeutics U.S. Holding LLC.
The drug will be manufactured at Unit-III of the company, and Aurobindo Pharma plans an immediate launch in the market.
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