Aurobindo Pharma gains 2% on USFDA approvals for two drugs

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26 Aug, 2025 12:21

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Shares of Aurobindo Pharma climbed 1.9 percent intraday Thursday after getting approval from the US Food & Drug Administration for its anti-diarrheal and anti-inflammatory drugs.

Aurobindo has received approval from the USFDA to manufacture and market Methylprednisolone sodium succinate injection (USP, 40 mg/vial, 125 mg/vial, 500 mg/vial, & 2 g/vial) and Loperamide hydrochloride tablet (2 mg), the Hyderabad-based pharma company says in its filing.

Methylprednisolone sodium succinate is bioequivalent and therapeutically equivalent to drug Solu-Medrol of Pharmacia & Upjohn Company. It is a lyophilized product used in the treatment of various medical conditions viz allergic states, disorders etc. It has an estimated market size of USD 102 million for 12 months ending October 2015, according to IMS.

Loperamide hydrochloride tablet, which is expected to be launched in Q4FY16, is bioequivalent to drug Imodium A-D of Johnson & Johnson Consumer Inc (the McNeil Consumer Healthcare division). The drug is used to control symptoms of diarrhea, including travelers’ diarrhea. This product has an estimated market size of USD 9.7 million for 12 months ending October 2015, according to IMS.

With these approvals, Aurobindo now has a total of 224 abbreviated new drug applications (ANDA) approvals (196 final approvals including 10 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA.

The company has so far received six approvals in December itself and total 10 approvals in current quarter. The stock rallied 9 percent during the quarter.

At 12:50 hours IST, the scrip of Aurobindo Pharma was quoting at Rs 832.85, up Rs 12.50, or 1.52 percent on the BSE.Posted by Sunil Shankar Matkar