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Gland Pharma Receives USFDA Approval for Olopatadine Hydrochloride Ophthalmic Solution 

By Shishta Dutta | Published at: Jan 8, 2026 01:13 PM IST

Gland Pharma Receives USFDA Approval for Olopatadine Hydrochloride Ophthalmic Solution 
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Mumbai,8 Jan 2026: The company Gland Pharma Limited (BSE: 543245) states that it has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug  Application (ANDA) for Olopatadine Hydrochloride Ophthalmic Solution (0.7% OTC or over-the-counter) eye drop for the treatment of ocular itching associated with allergic conjunctivitis (in other words, allergies). This approval will add additional drug options to the company’s portfolio in the United States, as announced under the SEBI Regulations. 

Details of the Approved Product, Its Use 

This product is a generic version of the original prescription drug Pataday Once Daily Relief 0.7% which is marketed by Alcon Laboratories Inc. Both products contain the active ingredient olopatadine hydrochloride and are indicated for the relief of eye irritation associated with allergy, and the fact that this product is available over-the-counter means the general population may have better access to it, since they do not require a doctor’s prescription to purchase it. 

Stock Performance and Market Capitalisation 

The Gland Pharma’s share price has been positively impacted by its success in obtaining U.S. Food and Drug Administration approval. On January 7th, 2026 the stock closed at ₹1,710.00 on NSE, representing a rise of ₹16.70 from the previous trading day or 0.99% hike. This movement was an indication of how investors reacted to the regulatory milestone achieved by the respective company. As on 8 January 2026, 10:45 AM IST, the company’s stock is traded at ₹1,718 with a market capitalisation of approximately ₹28,147 crores, thus reinforcing the company’s competitive position within the global pharmaceutical industry. 

Company Overview and Corporate Company Profile 

Gland Pharma Limited (002276) was registered in 1978, and is based out of Hyderabad, India. Gland operates worldwide, with many injectable and ophthalmic pharmaceuticals for the regulated Markets of the USA, Europe, Canada, Australia, and India, etc. 

Regulatory Impact and Market Position 

The recent FDA approval for Olopatadine Bausch Health’s eye drops enhances Gland Pharma’s product line on the regulated side while maintaining its position in the ophthalmologic (eye) market. The approval continues to show the company’s large global regulatory footprint and demonstrates incremental new growth opportunities in their regulatory portfolio. 

References: https://www.bseindia.com/stock-share-price/gland-pharma-ltd/gland/543245/corp-announcements/ 

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Please note that the information shared is intended solely for informational purposes and does not make any investment recommendations 

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