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  1. Caplin Point Laboratories’ subsidiary Caplin Steriles gets USFDA nod for Ofloxacin Ophthalmic Solution

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Caplin Point Laboratories’ subsidiary Caplin Steriles gets USFDA nod for Ofloxacin Ophthalmic Solution

Upstox

2 min read | Updated on April 16, 2024, 18:08 IST

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SUMMARY

Caplin Point Laboratories said Ofloxacin Ophthalmic Solution USP 0.3% is indicated for treatment of eye infections caused during the conditions of conjunctivitis and corneal ulcers. The company pointed out that as per IQVIATM (IMS Health), Ofloxacin Ophthalmic Solution USP 0.3% had US sales of approximately $52 million for the 12-month period ending December 2023.

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Caplin Point Laboratories’ subsidiary Caplin Steriles gets USFDA nod for Ofloxacin Ophthalmic Solution

Caplin Point Laboratories’ subsidiary Caplin Steriles has been granted a final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Ofloxacin Ophthalmic Solution USP 0.3% (eye drops), the company said in an exchange filing.

Ofloxacin Ophthalmic Solution USP 0.3% is indicated for treatment of eye infections caused during the conditions of conjunctivitis and corneal ulcers. The company pointed out that as per IQVIATM (IMS Health), Ofloxacin Ophthalmic Solution USP 0.3% had US sales of approximately $52 million for the 12-month period ending December 2023.

Caplin Steriles is a sterile product manufacturing company. It has developed and filed 41 ANDAs in USA on its own and with partners, with 27 approvals so far. The company is also working on a portfolio of over 40 simple and complex injectable and ophthalmic products, which it intends to file over the next four years.

Shares of Caplin Point Laboratories ended 1.48% higher on Tuesday.

During the third quarter of the fiscal year 2024, the company reported a 17% rise in its consolidated revenue from operations at ₹435.60 crore. Earnings before interest, tax, depreciation and amortisation (EBITDA) rose 29.1% to ₹159.46 crore while EBITDA margin improved to 35.2% compared to 32% in the same period a year ago.

The company reported a 23% rise in its net profit at ₹119.82 crore during the quarter.

CC Paarthipan, Chairman had said approval from Colombia’s INVIMA for the company’s Caplin Steriles site will accelerate growth in newer markets like Mexico, Chile and Colombia. “We remain committed to driving sustainable growth with strong cash flows,” he said.

During the third quarter results announcement the company had said it has allocated an overall capex budget of approximately ₹600-650 crore for the investment projects, most of which are nearing completion.

Shares of Caplin Point Laboratories have lost over 2.5% since the beginning of the year. The stock has risen over 112% in the last one year.

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