Granules arm gets FDA tentative nod for ADHD generic in about USD 172M market

Regulatory Product ApprovalBusiness Updates View source PDF Explain this filing

GRANULES · price

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▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.

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

+2.7%Reaction day

₹583.30

prior close

₹585.10

announcement price

After-mkt

timing

Nifty Smallcap 250market · index membership as recorded later (tracked since Jun 2026)+1.0%+1.7% vs market

Pharmaceuticals peers, median of 155sector+0.7%+2.0% vs sector

On the reaction day the stock moved 1.7 pts more than Nifty Smallcap 250 and 2.0 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

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Sessions after the filingfrom the prior close

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Reaction day

+2.7+1.0+1.7+0.7+2.0

Next day

+5.6+1.4+4.2+0.6+5.0

+5.0+1.4+3.6+0.6+4.4

+5.5+1.3+4.2+0.0+5.5

+3.3+0.7+2.6-0.7+4.0

+2.5+0.5+2.0-0.8+3.3

+6.3+1.6+4.7-0.0+6.3

15d

+1.0-1.2+2.2-2.1+3.2

-1.9-4.8+2.9-6.2+4.3

+2.5-2.3+4.8-5.6+8.1

+0.6-13.3+13.8-13.7+14.3

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

Granules Pharmaceuticals Inc, the US arm of Granules India, received FDA Tentative Approval for generic Amphetamine Extended-Release Orally Disintegrating Tablets (ADZENYS XR-ODT) for ADHD treatment in six strengths. Target market is around USD 172 million per IQVIA. The product will be made at the Chantilly, Virginia facility. Currently only one generic and one authorised generic exist in this market, placing Granules favourably for launch.

Likely market impact

Positive for US generics. Tentative status means launch waits on patent or exclusivity expiry. Strengthens CNS portfolio in a roughly USD 172M ADHD market.