Pharma Stock Receives Approval for Sodium Phosphates Injection to Enter $67M US Sales Segment

Synopsis: Caplin Point shares are in focus after its subsidiary received USFDA approval for Sodium Phosphates Injection in a $67 million US sales segment. The nod strengthens its regulated market presence and sterile portfolio. Backed by 51 US approvals and a strong pipeline, the move enhances long-term growth visibility.

The shares of this company, which is engaged in the manufacturing and sourcing of APIs, finished formulations, R&D and clinical research and has a presence in Latin America, Africa, the USA and other nations, were in focus after the company got USFDA approval for Sodium Phosphates Injections.

With a market cap of Rs 12,962 crore, the shares of Caplin Point Laboratories Ltd are trading at Rs 1,700; the shares are trading at a PE of 21.1 compared to its industry PE of 28.3. The shares have given a return of more than 260% in the last 5 years.

About the USFDA Approval 

The subsidiary of Caplin Point Laboratories, Caplin Steriles Limited, has received final approval from the USFDA for its ANDA for Sodium Phosphates Injection USP in three strengths (15mM P/5mL, 45mM P/15mL, and 150mM P/50mL single-dose vials). The drug is a generic version of the reference-listed drug marketed by Hospira and is indicated for the prevention or treatment of hypophosphatemia in patients who require intravenous supplementation.

The approval allows the company to enter the US market, which had total sales of around $67 million for the 12 months ending December 2025, as per IQVIA data. Although this data is not the revenue of the company, it gives an indication of the regulated market opportunity that Caplin has in the sterile injectable market.

Strategically, this approval enhances Caplin Steriles’ presence in the regulated market. The subsidiary has submitted 54 ANDAs in the US and has received 51 approvals so far, which is a remarkable record in terms of compliance and delivery. With an upcoming pipeline of 55+ injectable and ophthalmic products scheduled for filing over the next four years, the company is creating long-term visibility in the US generics market.

In summary, this USFDA approval further cements Caplin Point’s foray into more valuable regulated markets, apart from its core emerging market strategy. With several global regulatory approvals, including USFDA and EU-GMP, the company is further bolstering its sterile manufacturing capabilities, which could contribute to incremental revenue growth and enhanced product diversification in the long run.

Financials

The revenue from operations for the company stood at Rs 543 crores in Q3 FY26 compared to Q3 FY25 revenue of Rs 493 crores, up by about 10 per cent YoY. Similarly, the net profit stood at Rs 166 crore in Q3 FY26, up compared to the Rs 140 crore profit in Q3 FY25.

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