Gland Pharma shares surge after USFDA approves ANDA for ophthalmology drug

Shares of the Hyderabad-based drug maker Gland Pharma rose as much as 4.8% to hit an intraday high of ₹1,790.40 on the National Stock Exchange on Thursday, January 8. On the BSE, Gland Pharma shares gained as much as 5.11% to hit an intraday high of ₹1,795.85 after the company informed exchanges that its new Abbreviated New Drug Application (ANDA) for ophthalmic solution received approval from the United States Food and Drug Administration (USFDA).

Gland Pharma post market hours on Wednesday said that it received approval from USFDA for its Abbreviated New Drug Application filed for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC).

"Gland Pharma Limited (Gland or Company), a generic injectable & ophthalmic focused pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application filed for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC)," Gland Pharma said in a press release.

The product is therapeutically equivalent to the reference listed drug (RLD), Pataday Once Daily Relief, 0.7%, of Alcon Laboratories Inc (Alcon) and it is indicated for the treatment of ocular itching associated with allergic conjunctivitis.

About Gland Pharma

Gland Pharma was established in 1978 in Hyderabad and has grown over the years from a contract manufacturer of small-volume liquid parenteral products to become one of the largest injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets.

It operates primarily under a business-to-business (B2B) model and has an excellent track record in developing, manufacturing, and marketing sterile injectables. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions. It also enjoys the distinction of having pioneered Heparin technology in India.

As of 9:43 am, Gland Pharma shares traded 1.74% higher at ₹1,727.60, outperforming the NIFTY Smallcap 100 index which was down 0.22%.