Actions of Caplin Point Laboratoriesa pharmaceutical company, rose 15% in intraday trading today, hitting an all-time high of ₹1,817 per share. The increase followed the company’s announcement in a filing on Saturday that the Caplin Steriles injectable and ophthalmic manufacturing plant, a subsidiary of Caplin Point Laboratories, had successfully passed an inspection by Brazilian health regulator Anvisa.
“Anvisa-Brasil carried out an inspection at the Caplin Steriles injectable and ophthalmic manufacturing plant, located in Gummidipoondi. The inspection was carried out between August 12 and 16, 2024 and concluded without any observations,” the company said.
On August 9th, the The US Food and Drug Administration (US FDA) also conducted an unannounced inspectionwhich concluded with zero observations.
President, Mr. CC Paarthipan, said: “It is truly gratifying to have two consecutive audits without any observations. We remain steadfast in our commitment to maintaining the highest levels of quality compliance across all our plants. Brazil is an important part of our expansion plans in Latin America and this clearance opens the door for us to the largest market in that geography.”
Caplin Steriles is approved by several regulatory agencies, including the US FDA, EU-GMP, ANVISA and INVIMA. It has developed and submitted 42 ANDAs in the US on its own and with partners, with 30 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 within the next 4 years, Caplin Point said in its latest regulatory filing.
The company also has multiple products registered with various approvals in non-US markets such as Mexico, Australia, Canada, South Africa, etc.
On August 8, Caplin Steriles received final approval from the U.S. 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 Bausch and Lomb Inc.’s reference listed drug (RLD) TIMOPTIC.
Earnings
For the quarter ending in June, the company reported operating income of ₹458.96 crore, reflecting a year-on-year increase of 16.1%. The company’s PAT for the first quarter of FY25 stood at ₹124.92 crore, a year-on-year growth of 19.8%. Revenue from the US market for the first quarter of FY25 was ₹77.93 crore, an impressive year-on-year increase of 68.9%.
Meanwhile, the company’s shares have been on an upward trend since March 2023increasing by 203% year-to-date.
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