Caplin Point Lab gets INVIMA nod for Softgel capsules division

The site inspection of its “Unit-1” was completed on May 3 and found compliant with INVlMA's norms of good manufacturing practices (GMP) and good laboratory practices (GLP), it said.

The INVIMA nod is crucial as the unit currently caters to emerging markets of Latin America, along with Africa. The variety of dosage forms includes tablets, capsules, softgel capsules, suppositories, liquid orals, topicals, and injectables.

CC Paarthipan, Chairman at Caplin Point Laboratories said expansion into larger markets of Latin America such as Colombia is an important aspect of the firm’s future growth, and this approval, especially in the niche Softgel capsules range will contribute well to the same.

Last month, the company said its subsidiary Caplin Steriles was granted 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).

Ofloxacin Ophthalmic Solution USP 0.3% is indicated for the treatment of eye infections caused by 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.

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 the 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.

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.