Caplin Point stock spikes 15% as subsidiary clears Brazilian health regulator’s inspection

Shares of Caplin Point Laboratories, a pharmaceutical company, surged 15% in today's intraday trading, reaching an all-time high of ₹1,817 per share. This spike followed the company's announcement, made via an exchange filing on Saturday, that the injectable and ophthalmic manufacturing plant of Caplin Steriles, a subsidiary of Caplin Point Laboratories, had successfully cleared an inspection by the Brazilian health regulator Anvisa.

"Anvisa-Brazil conducted an inspection of Caplin Steriles’ injectable and ophthalmic manufacturing facility located at Gummidipoondi. The inspection was conducted between August 12th and 16th, 2024, and concluded with zero observations," the company said.

On August 09, the United States Food and Drug Administration (US FDA) also conducted an unannounced inspection, which concluded with zero observations.

Chairman Mr C C Paarthipan said, “It is indeed gratifying to have two back-to-back audits with zero observations. We remain steadfast in our commitment to maintaining the highest levels of quality compliance at all our sites. Brazil is an important part of our expansion plans in Latin America, and this clearance opens the door to the largest market in that geography.”

Caplin Steriles is approved by several regulatory agencies, such as the US FDA, EU-GMP, ANVISA, and INVIMA. It has developed and filed 42 ANDAs in the USA on its own and with partners, with 30 approvals so far. The company is also working on a portfolio of 40+ simple and complex injectable and ophthalmic products, that it intends to file over the next 4 years, Caplin Point said in its latest regulatory filing. 

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

On August 8, Caplin Steriles received final approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Timolol Maleate Ophthalmic Solution USP, 0.5% (eye drops), which is a generic equivalent of the Reference Listed Drug (RLD) TIMOPTIC by Bausch and Lomb Inc.

Earnings

For the June-ending quarter, the company reported operating revenue of ₹458.96 crore, reflecting a 16.1% year-over-year increase. The company's PAT for Q1 FY25 stood at ₹124.92 crore, marking 19.8% year-over-year growth. Revenue from the U.S. market for Q1 FY25 was ₹77.93 crore, an impressive 68.9% year-over-year increase.

Meanwhile, the company's shares have been on an upward trend since March 2023, surging by 203% to date.

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