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Caplin Point Shares Gain 2% on USFDA Approval for Eye Treatment Drug

The eye drops used for the treatment for eye infections, particularly conjunctivitis and corneal ulcers.

Shares of Caplin Point Laboratories Ltd were trading 2% higher on 16 April after the United States Food and Drug Administration (USFDA) gave its subsidiary Caplin Sterile Ltd final approval for a medication to treat eye infections.

The business announced in a stock exchange statement that the US drug regulator has approved its subsidiary’s supply of Ofloxacin Ophthalmic Solution, which is used to treat eye infections.

An Abbreviated New Drug Application (ANDA) for Ofloxacin Ophthalmic Solution USP 0.3%, a frequently used eye drop, has been received by the business.

As an alternative to the branded version, OCUFLOX Ophthalmic Solution of Allergan Inc., this clearance places Caplin as a player in the generic therapeutic equivalent market, according to a stock exchange filing by Caplin Point Labs.

The eye drops used for the treatment for eye infections, particularly conjunctivitis and corneal ulcers, is advised for ofloxacin Ophthalmic Solution USP 0.3%. The goal of Chennai-based Caplin’s approval is to offer patients efficient treatment choices.

With over $52 million in revenue for the 12-month period ending in December 2023, Ofloxacin Ophthalmic Solution USP 0.3% recorded noteworthy sales in the US, according to IQVIATM (IMS Health).

Caplin Steriles, working alone and in conjunction with partners, has created and filed 41 ANDAs in the US, with 27 of those submissions receiving approval. In addition, the business is working hard to make a broad portfolio of more than 40 injectable and ophthalmic treatments, both basic and sophisticated, that it plans to submit over the next four years.

Moreover, Caplin Steriles has several products that are presently being reviewed and approved in non-US international markets, such as South Africa, Australia, Canada, Mexico, and others.

Caplin Point Laboratories anticipates four new medicines being introduced in the US ophthalmic injectables market in February. These products are expected to play a major role in the company’s growth within the US market.

At 3:30 PM, Caplin Point Laboratories shares closed 1.48% higher at Rs 1,319.90 on NSE.

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