Glenmark Pharmaceuticals has achieved a significant milestone with the receipt of approval from the US health regulator to market a generic version of an anti-inflammatory drug in the American market.
In a statement released on Monday, the Mumbai-based pharmaceutical company announced that it has obtained approval from the US Food and Drug Administration (USFDA) for Acetaminophen and Ibuprofen tablets (250 mg/125 mg).
The approved product by Glenmark Pharmaceuticals is the generic version of Haleon US Holdings, LLC’s Advil 2 Dual Action with Acetaminophen Tablets, 250 mg/125 mg (OTC).
Glenmark Therapeutics Inc, USA, will spearhead the distribution of the drug in the US market, ensuring accessibility to patients across the nation.
According to Nielsen syndicated data for the latest 52-week period ending March 23, 2024, the Advil Dual Action with Acetaminophen Tablets, 250 mg/125 mg, achieved annual sales of approximately USD 84.1 million, indicating a significant market potential for Glenmark’s generic alternative.
Glenmark Pharmaceuticals highlighted its robust presence in the US marketplace, boasting a portfolio comprising 195 products authorized for distribution and 52 abbreviated new drug applications (ANDAs) pending approval with the USFDA.
Following the announcement, shares of Glenmark Pharma experienced a marginal increase, trading at Rs 1,080.45 apiece on the BSE, reflecting positive investor sentiment towards the company’s latest achievement in the pharmaceutical sector.
