Indoco Remedies gets USFDA final approval for Lacosamide Oral Solution

Regulatory Product ApprovalBusiness Updates View source PDF Explain this filing

INDOCO · price

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

+1.7%Reaction day

₹213.50

prior close

₹221.59

announcement price

In-mkt

timing

Nifty Microcap 250market · in no size index; the smallest one is used+1.8%-0.1% vs market

Pharmaceuticals peers, median of 157sector+0.9%+0.8% vs sector

On the reaction day the stock moved 0.1 pts less than Nifty Microcap 250 and 0.8 pts more than its Pharmaceuticals peers, over the same two closes: a difference in percentage points, not a measure of what the filing did.

Minutes after the announcementfrom the announcement price · no benchmark

Stock

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15m

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30m

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Sessions after the filingfrom the prior close

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Reaction day

+1.7+1.8-0.1+0.9+0.8

Next day

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+10.1+4.3+5.8+2.4+7.7

+5.6+5.6-0.1+2.9+2.7

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15d

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UpDownMarket · Nifty Microcap 250Sector · Pharmaceuticals peers, median of 157Pending

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

AI summary

Indoco Remedies received final USFDA approval for its ANDA for Lacosamide Oral Solution USP, 10 mg/mL, a generic equivalent to UCB's Vimpat Oral Solution used to treat partial onset and tonic-clonic seizures in epilepsy patients aged 4 and above. The product will be manufactured at Indoco's Verna Industrial Area facility in Goa. The company has 11 manufacturing facilities and turnover of around US$180 million.

Likely market impact

Positive - new US generic approval strengthens Indoco's US portfolio and future revenue potential. No order size or launch timeline disclosed.