Granules India Share Price Touches 52-Week High on Sole First-to-File ANDA Status for Sodium Oxybate

Granules India share price touched a fresh 52 week high of Rs 865 on 6 July 2026 after the pharmaceutical manufacturer secured Sole First-to-File status for its Abbreviated New Drug Application for Sodium Oxybate Extended-Release for Oral Suspension, the generic equivalent of LUMRYZ extended-release oral suspension.

Sole First-to-File status is a significant regulatory milestone in the US generics market, as it typically confers a period of market exclusivity to the first company to successfully challenge a branded product’s patents, ahead of other generic competitors entering the space.

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About Granules India

Granules India is a Hyderabad headquartered pharmaceutical manufacturing company involved in finished dosage forms, pharmaceutical formulation intermediates and active pharmaceutical ingredients, and is among the larger global manufacturers of first line therapeutic products including paracetamol, metformin and ibuprofen.

Why Granules India Share Price Is in Focus Today

Granules India share price is in focus because Sole First-to-File status on a complex, high value molecule like Sodium Oxybate represents a meaningful opportunity in a therapeutic category with limited generic competition. Investors tracking Granules India share price can view live quotes and fundamentals on the Univest stock page for Granules India before assessing the significance of this filing status.

What Sodium Oxybate Treats

Sodium Oxybate is used to treat symptoms of narcolepsy, specifically cataplexy and excessive daytime sleepiness. LUMRYZ, the reference brand product, is marketed by Avadel Pharmaceuticals, which was acquired by Alkermes in a deal completed earlier in 2026, and is the first and only once-at-bedtime treatment approved for this indication in adults, and later extended to pediatric patients.

Why Sole First-to-File Status Matters

Sole First-to-File status means Granules India is currently the only generic applicant positioned for potential exclusivity on this Abbreviated New Drug Application, which can translate into a meaningful revenue opportunity during any exclusivity window before additional generic competitors are approved. Complex, controlled substance formulations like extended-release Sodium Oxybate typically carry higher barriers to entry than standard oral generics, supporting more durable pricing during the exclusivity period.

Granules India Key Stock Data

The table below summarises the key data points around this ANDA filing and the stock’s reaction.

Metric	Value
ANDA Product	Sodium Oxybate Extended-Release for Oral Suspension
Reference Brand	LUMRYZ (Alkermes / Avadel Pharmaceuticals)
Filing Status	Sole First-to-File
CMP	Rs 853.10
52-Week High (Fresh)	Rs 865

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Granules India Share Price and Recent Performance

Granules India share price was quoting at Rs 853.10, up Rs 19.95 or 2.39 percent, after touching an intraday high of Rs 865 and a low of Rs 834.95. Trading volumes stood at 19,545 shares, compared to the five day average of 87,599 shares, a decrease of 77.69 percent, even as the stock made a fresh 52 week high on the back of this regulatory milestone.

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What This ANDA Status Means for Granules India

Sole First-to-File status on a complex, controlled substance product like Sodium Oxybate adds a differentiated, high value opportunity to Granules India’s pipeline, distinct from the company’s traditional focus on high volume, commoditised first line therapeutics like paracetamol and metformin. The eventual revenue contribution will depend on the timing of final FDA approval and the length of any exclusivity period the company is able to secure, factors that are not yet fully confirmed at this stage.

Conclusion

Granules India share price touched a fresh 52 week high of Rs 865 on 6 July 2026 after securing Sole First-to-File status for its Sodium Oxybate Extended-Release ANDA, the generic equivalent of LUMRYZ. The stock was trading around Rs 853.10 during the session. Track the final FDA approval timeline and consult a SEBI registered advisor before making any investment decision.

Frequently Asked Questions on Granules India Share Price

Why is Granules India share price in focus today?

Ans. Granules India share price touched a fresh 52-week high on 6 July 2026 after the company secured Sole First-to-File status for its ANDA for Sodium Oxybate Extended-Release for Oral Suspension, the generic equivalent of LUMRYZ.

What is Sodium Oxybate used to treat?

Ans. Sodium Oxybate is used to treat narcolepsy symptoms, specifically cataplexy and excessive daytime sleepiness, with LUMRYZ being the branded once-at-bedtime reference product for this indication.

What does Sole First-to-File status mean for Granules India?

Ans. Sole First-to-File status means Granules India is currently the only generic applicant positioned for potential market exclusivity on this ANDA, which can translate into a meaningful revenue opportunity ahead of additional generic competition.

What was Granules India share price on 6 July 2026?

Ans. Granules India share price was quoting at Rs 853.10, up 2.39 percent, after touching a fresh 52-week high of Rs 865 and a low of Rs 834.95 during the session.

Who markets the branded LUMRYZ product?

Ans. LUMRYZ is marketed by Avadel Pharmaceuticals, which was acquired by Alkermes in a deal completed earlier in 2026, and is approved as a once-at-bedtime treatment for narcolepsy symptoms in adults and pediatric patients.

Is Granules India share price a buy after this ANDA news?

Ans. This article does not constitute investment advice. The eventual revenue contribution depends on final FDA approval timing and any exclusivity period secured. Review the company’s financials and consult a SEBI registered financial advisor before making any investment decision.