Caplin Steriles gets USFDA approval for Methylprednisolone Injection

Regulatory Product ApprovalBusiness Updates View source PDF Explain this filing

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Price reactionminutes from the announcement price · days from the prior close

+1.4%Reaction day

₹1730.10

prior close

₹1750.00

announcement price

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Nifty Smallcap 250market · index membership as recorded later (tracked since Jun 2026)+1.9%-0.5% vs market

Pharmaceuticals peers, median of 155sector+0.7%+0.7% vs sector

On the reaction day the stock moved 0.5 pts less than Nifty Smallcap 250 and 0.7 pts more than its Pharmaceuticals peers, over the same two closes: a difference in percentage points, not a measure of what the filing did.

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Next day

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UpDownMarket · Nifty Smallcap 250Sector · Pharmaceuticals peers, median of 155Pending

Minute windows have no benchmark: there is no intraday index history to compare against.

AI summary

Caplin Steriles, subsidiary of Caplin Point Labs, received final USFDA approval for its generic Methylprednisolone Acetate Injectable Suspension USP, 40 and 80 mg per mL single-dose vials, equivalent to Pfizer's DEPO-MEDROL. The product targets a US market of about $57.4 million for the 12 months ending November 2025 per IQVIA data. CSL now holds 50 approved ANDAs in the US.

Likely market impact

Positive. Opens a new US revenue stream for the injectables business and adds to Caplin Steriles' growing USFDA-approved portfolio of 50 ANDAs.