Alembic Pharma gets tentative USFDA nod for Olopatadine drug; stock up 2%

Shares of pharmaceutical company Alembic Pharmaceuticals advanced 2.15 per cent to Rs 1,123 on the National Stock Exchange (NSE) during intra-day deals on Wednesday, December 4, 2024.  The northward movement in the company’s share price followed news that the company had received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7 per cent (OTC).

 

“The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pataday Once Daily Relief Ophthalmic Solution, 0.7 per cent, of Alcon Laboratories, Inc. (Alcon) NDA - 206276. Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7 per cent (OTC) is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair, and dander. Refer to the label for detailed indications,” the company said in a release.

 

 

In its filing, the company further stated, “The OTC market has an estimated size of $22 million for the twelve months ending September 2024, according to IQVIA. Alembic has a cumulative total of 219 ANDA approvals (192 final approvals and 27 tentative approvals) from the USFDA.”

 

Headquartered in India, Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company that manufactures and markets generic pharmaceutical products worldwide. Alembic's state-of-the-art research and manufacturing facilities are approved by regulatory authorities in many developed countries, including the USFDA.

 

As of December 4, 2024, the company had a market capitalisation of Rs 21,660.27 crore on the NSE.

 

Shares of Alembic Pharmaceuticals have delivered a return of 43.73 per cent year-to-date.

 

The pharmaceutical company’s shares have a 52-week range of Rs 1,303.90 to Rs 736.95 on the NSE, as of December 4.

 

At around 11:38 AM on Wednesday, Alembic Pharmaceuticals shares were trading at Rs 1,105.95, up 0.60 per cent from their previous close on the NSE. Nearly 0.09 million shares of Alembic Pharmaceuticals, worth approximately Rs 10.51 crore, had changed hands on the NSE and BSE so far.

 

In contrast, the BSE Sensex was trading at 80,945.73, up 99.98 points or 0.12 per cent, while the NSE Nifty50 was down 11.25 points or 0.05 per cent at 24,445.90.