Caplin Point Laboratories Ltd

The approval covers Sodium Phosphates Injection USP in strengths of 15mM P/5mL, 45mM P/15mL and 150mM P/50mL (3mM P/mL) single-dose vials. The product is a generic therapeutic equivalent of the Reference Listed Drug (RLD), approved under NDA 018892 and marketed by Hospira, Inc., USA. Sodium Phosphates Injection is indicated as a source of phosphorus for addition to large volume intravenous fluids to prevent or treat hypophosphatemia in patients with limited or no oral intake. It is also used in the preparation of customised parenteral nutrition formulations when standard electrolyte or nutrient solutions are inadequate to meet patient requirements. According to IQVIA (IMS Health) data, the approved strengths of Sodium Phosphates Injection recorded total US sales of approximately $67 million for the 12-month period ended December 2025. Caplin Point Laboratories is a pharmaceutical company with a unique business model catering predominantly to emerging markets of Latin America and Africa. The company also has a growing presence in the regulated markets such as US through its subsidiary Caplin Steriles and Caplin Steriles USA Inc. The company's consolidated net profit rose 17.9% to Rs 163.88 crore while net sales increase 10.1% to Rs 542.77 crore in Q3 FY26 over Q3 FY25. The counter declined 1.49% to Rs 1,706.90 on the BSE. Powered by Capital Market - Live

Net profit of Caplin Point Laboratories rose 17.93% to Rs 163.88 crore in the quarter ended December 2025 as against Rs 138.96 crore during the previous quarter ended December 2024. Sales rose 10.10% to Rs 542.77 crore in the quarter ended December 2025 as against Rs 492.96 crore during the previous quarter ended December 2024. ParticularsQuarter EndedDec. 2025Dec. 2024% Var. Sales542.77492.96 10 OPM %34.9432.92 - PBDT223.17193.46 15 PBT203.89177.26 15 NP163.88138.96 18 Powered by Capital Market - Live

Caplin Point Laboratories will hold a meeting of the Board of Directors of the Company on 5 February 2026.Powered by Capital Market - Live

Net profit of Caplin Point Laboratories rose 18.08% to Rs 154.45 crore in the quarter ended September 2025 as against Rs 130.80 crore during the previous quarter ended September 2024. Sales rose 10.54% to Rs 534.04 crore in the quarter ended September 2025 as against Rs 483.10 crore during the previous quarter ended September 2024. ParticularsQuarter EndedSep. 2025Sep. 2024% Var. Sales534.04483.10 11 OPM %35.4234.08 - PBDT219.40185.22 18 PBT201.00168.46 19 NP154.45130.80 18 Powered by Capital Market - Live

Net profit of Caplin Point Laboratories declined 2.98% to Rs 102.59 crore in the quarter ended September 2025 as against Rs 105.74 crore during the previous quarter ended September 2024. Sales declined 15.75% to Rs 175.18 crore in the quarter ended September 2025 as against Rs 207.93 crore during the previous quarter ended September 2024. ParticularsQuarter EndedSep. 2025Sep. 2024% Var. Sales175.18207.93 -16 OPM %43.3047.21 - PBDT135.02141.15 -4 PBT129.00134.66 -4 NP102.59105.74 -3 Powered by Capital Market - Live

Caplin Point Laboratories will hold a meeting of the Board of Directors of the Company on 5 November 2025.Powered by Capital Market - Live

The said drug is equivalent to reference listed drug (RLD) from Hikma International Pharmaceuticals LLC. Nicardipine Hydrochloride in 0.9% Sodium Chloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable. According to IQVIA (IMS Health), Nicardipine Hydrochloride in Sodium Chloride injection had US sales of approximately $68 million for the 12-month period ending August 2025. The company recently acquired the four approved ANDA products, Icatibant Acetate Injection, Paricalcitol Injection, Gatifloxacin Ophthlamic Solution and Ketamine Hydrochloride Injection from third parties. According to IQVIA (IMS Health), the collective market size for the above products in the US is approximately $121 million for the 12-month period ending August 2025. These products will be introduced into US and other markets in 2026. Caplin Point Laboratories is a pharmaceutical company with a unique business model catering predominantly to emerging markets of Latin America and Africa. The company also has a growing presence in the regulated markets such as US through its subsidiary Caplin Steriles and Caplin Steriles USA Inc. The company reported an 11.2% year-on-year (YoY) increase in revenue from operations to Rs 510.2 crore and a 20.7% YoY rise in profit after tax (PAT) to Rs 150.8 crore in Q1 FY26. The scrip declined 1.18% to Rs 2002.40 on the BSE.Powered by Capital Market - Live

Caplin Steriles (Caplin), a subsidiary company of Caplin Point Laboratories, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL (0.2 mg/mL) and 40 mg/200 mL (0.2 mg/mL) Single-dose Infusion Bags, a generic therapeutic equivalent version of the Reference Listed Drug (RLD) PRIMACOR in Dextrose 5%, by Sanofi Aventis US LLC. Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. According to IQVIATM (IMS Health), Milrinone Lactate in 5% Dextrose Injection had US sales of approximately $11 million for the 12-month period ending July 2025. Powered by Capital Market - Live

The approval covers two dosage forms'20 mg/100 mL (0.2 mg/mL) and 40 mg/200 mL (0.2 mg/mL)'in single-dose infusion bags. The product is a generic therapeutic equivalent version of the Reference Listed Drug (RLD), PRIMACOR in Dextrose 5%, by Sanofi Aventis US LLC. Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. According to IQVIATM (IMS Health), Milrinone Lactate in 5% Dextrose Injection had US sales of approximately $11 million for the 12-month period ending July 2025. Caplin Point Laboratories is a pharmaceutical company with a unique business model catering predominantly to emerging markets of Latin America and Africa. The company also has a growing presence in the regulated markets such as US through its subsidiary Caplin Steriles and Caplin Steriles USA Inc. The company reported an 11.2% year-on-year (YoY) increase in revenue from operations to Rs 510.2 crore and a 20.7% YoY rise in profit after tax (PAT) to Rs 150.8 crore in Q1 FY26. Powered by Capital Market - Live

Caplin Point Laboratories announced that the 34th Annual General Meeting(AGM) of the company will be held on 22 September 2025.Powered by Capital Market - Live