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

(Delhi) Shares of Caplin Point Laboratories soared by 15% in intraday trading today, reaching an all-time high of ₹1,817 per share. This surge in the stock price follows the company's announcement that its subsidiary, Caplin Steriles, has successfully cleared critical inspections by both the Brazilian health regulator Anvisa and the United States Food and Drug Administration (US FDA).

On Saturday, Caplin Point Laboratories disclosed via an exchange filing that Anvisa had completed an inspection of Caplin Steriles’ injectable and ophthalmic manufacturing plant located in Gummidipoondi, Tamil Nadu. The inspection, which took place from August 12 to 16, 2024, concluded with zero observations, indicating that the facility met all required standards without any issues. This positive outcome from Anvisa is particularly significant as Brazil represents a key market in Caplin Point’s expansion strategy in Latin America.

Just days earlier, on August 9, the US FDA had also conducted an unannounced inspection of the same facility. The inspection also concluded with zero observations, marking back-to-back successes for Caplin Steriles. Commenting on these developments, Chairman C.C. Paarthipan expressed satisfaction with the results. "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," he stated.

Caplin Steriles is approved by several major regulatory agencies, including the US FDA, EU-GMP, ANVISA, and INVIMA. The subsidiary has developed and filed 42 abbreviated new drug applications (ANDAs) in the USA, with 30 approvals granted so far. The company is actively working on a portfolio of over 40 simple and complex injectable and ophthalmic products, with plans to file these over the next four years.

In another significant achievement, Caplin Steriles received final approval from the US FDA on August 8 for its ANDA for Timolol Maleate Ophthalmic Solution USP, 0.5%, a generic version of TIMOPTIC by Bausch and Lomb Inc. This approval is expected to further bolster Caplin Steriles' presence in the competitive ophthalmic market.

For the quarter ending June 2024, Caplin Point Laboratories reported operating revenue of ₹458.96 crore, reflecting a 16.1% year-over-year increase. The company’s profit after tax (PAT) for Q1 FY25 was ₹124.92 crore, marking a 19.8% growth compared to the previous year. Notably, revenue from the US market saw a remarkable 68.9% increase, reaching ₹77.93 crore.

The recent regulatory approvals and impressive financial performance have positioned Caplin Point Laboratories as a prominent player in the pharmaceutical industry, with a strong outlook for future growth. The stock’s sharp rise today underscores investor confidence in the company's ongoing expansion and regulatory achievements.