Caplin Point’s subsidiary receives FDA approval for generic eye drops, shares up 2.78%

Caplin Point Laboratories Ltd’s shares were up by 2.78 per cent after the company reported that its subsidiary, Caplin Steriles Ltd, received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ketorolac tromethamine ophthalmic solution 0.5 per cent (eye drops).

This approval allows Caplin to market a generic therapeutic equivalent to Allergan Inc’s ACULAR Ophthalmic Solution.

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Ketorolac tromethamine ophthalmic solution 0.5 per cent is a nonsteroidal, anti-inflammatory medication used to treat inflammation following cataract surgery, and for the temporary relief of ocular itching due to seasonal allergic conjunctivitis.

According to IQVIATM (IMS Health), the product had US sales of approximately $36 million for the 12-month period ending December 2023.

The company reported that it developed and filed 39 ANDAs in the USA, with 26 approvals so far. Additionally, Caplin is working on a portfolio of 40+ simple and complex Injectable and Ophthalmic products, intending to file them over the next four years.

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The company also has products filed with several approvals in non-US markets such as Mexico, Australia, Canada, and South Africa.

The shares were up by 2.78 per cent to ₹1295 at 11.51 am on the BSE.