Caplin Point Laboratories Ltd Share Price – NSE  / BSE

Pharmaceuticals, Small Cap

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) Desmopressin Acetate Injection USP, 4 mcg/mL single-dose vials and 40 mcg/10 mL (4 mcg/mL) multiple-dose vials, a generic therapeutic equivalent version of the Reference Listed Drug (RLD) DDAVP (desmopressin acetate) Injection, 4 mcg/mL of Nordic Pharma Inc., (NDA 018938).

Desmopressin Acetate Injection is used to treat conditions like haemophilia A, von Willebrand disease, and central diabetes insipidus, helping to manage bleeding and regulate urine production. According to IQVIATM (IMS Health), Desmopressin Acetate injection USP, 4 mcg/mL single-dose vials and 40 mcg/10 mL (4 mcg/mL) multiple-dose vials had US sales of approximately $26 million for the 12-month period ending December 2025.

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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.

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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.

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Caplin Point Laboratories will hold a meeting of the Board of Directors of the Company on 5 February 2026.

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