Gland Pharma Limited has informed the Exchange regarding a press release dated January 07, 2026, titled "Gland Pharma receives approval from the United States Food and Drug Administration (USFDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC)".
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Gland Pharma has received USFDA approval for its Abbreviated New Drug Application (ANDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7%, an over-the-counter eye drop. The product is a generic equivalent of Alcon's Pataday Once Daily Relief, 0.7%, and is used to treat eye itching caused by allergic conjunctivitis. This adds another ophthalmic product to Gland Pharma's portfolio, which already spans sterile injectables and ophthalmic solutions sold across 60 countries. No specific revenue or market size figures were disclosed in the announcement.
This is a positive development as it expands Gland Pharma's US-approved product portfolio and opens up a new OTC opportunity in the lucrative US ophthalmic market. However, the financial impact is not quantified and is unlikely to be material in the near term.