Caplin Steriles gets USFDA approval; Shares Slip 0.10%

Mumbai, May 5: Caplin Point Laboratories Limited said its subsidiary Caplin Steriles Limited has received final approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Calcium Gluconate Injection, according to an exchange filing.

The USFDA approval covers Calcium Gluconate Injection USP in 100 mg/mL strength across 10 mL, 50 mL and 100 mL vial formats. The product is a therapeutic equivalent of the reference listed drug from Fresenius Kabi USA, LLC.

The company said the injection is used for treating acute symptomatic hypocalcaemia in both paediatric and adult patients. As per IQVIA data cited in the filing, the product recorded US sales of around $7 million for the 12-month period ending March 2026.

Stock Market Snapshot

Shares of Caplin Point Laboratories fell 0.10% to ₹1,734.60 as of 14:53 IST on May 5, 2026, compared with the previous close of ₹1,736.30, based on exchange data.

Caplin Stock Price Chart Source: NSE

Pipeline Remains Strong

The company said Caplin Steriles has filed 54 ANDAs in the US, including both in-house and acquired filings, and all 54 have received approvals.

It is also working on expanding its portfolio of injectable and ophthalmic products, with more than 55 filings planned over the next four years. Additional filings have already been submitted in other international markets.

Business Focus

Caplin Point Laboratories operates across regulated and emerging markets, with a presence in regions such as Latin America and Africa.

Through Caplin Steriles, the company has been building its injectable portfolio, adding to its broader pharmaceutical manufacturing and distribution business.

What it Means

The USFDA approval adds another product to Caplin’s US portfolio, but the immediate stock reaction remains muted.

Future gains are likely to depend on how well the product scales in the market and contributes to overall revenues.

Source:

• https://www.nseindia.com/get-quote/equity/CAPLIPOINT/Caplin-Point-Laboratories-Limited
• https://nsearchives.nseindia.com/corporate/CAPLINPOINT_05052026124214_Press_Release.pdf