Granules India secures Sole FTF status for Sodium Oxybate

1 min read Updated on 07 Jul 2026, 06:41 AM

Reviewed by

Anirudha BScanX News Team

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Granules India Limited announced it has secured Sole First-to-File status for its ANDA for Sodium Oxybate Extended-Release for Oral Suspension, the generic equivalent of LUMRYZ. This marks the company's second Sole FTF ANDA, following Amphetamine Extended-Release Tablets, and underscores its capabilities in complex generics.

*this image is generated using AI for illustrative purposes only.

Granules India has secured Sole First-to-File (FTF) status for its Abbreviated New Drug Application (ANDA) for Sodium Oxybate Extended-Release for Oral Suspension, the generic equivalent of LUMRYZ. This regulatory achievement marks the company's second Sole FTF ANDA, reinforcing its capabilities in complex generics for the U.S. market.

Regulatory Milestone

The approval for Sodium Oxybate Extended-Release for Oral Suspension highlights Granules India's strategic emphasis on complex and differentiated drug formulations. The product is indicated in the United States for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy.

Parameter	Details
Approval Type	Sole First-to-File (FTF) ANDA
Product	Sodium Oxybate Extended-Release for Oral Suspension
Therapeutic Indication	Cataplexy or excessive daytime sleepiness in narcolepsy
Reference Brand	LUMRYZ

Strategic Significance

This is Granules India's second Sole First-to-File ANDA, following its earlier success with Amphetamine Extended-Release Tablets. The FTF designation positions the company as a sole generic entrant during the exclusivity period, providing a competitive edge. Dr. Krishna Prasad Chigurupati, Chairman & Managing Director, stated that this achievement reflects the strength of the company's R&D and regulatory capabilities, reinforcing its commitment to building a differentiated portfolio.

Historical Stock Returns for Granules

1 Day	5 Days	1 Month	6 Months	1 Year	5 Years
-0.05%	-2.45%	+12.50%	+58.43%	+77.09%	+137.90%

What is the expected financial impact of the Sole FTF status on Granules India's revenue during the exclusivity period?

How will this approval influence Granules India's strategy for securing future Sole FTF designations in the complex generics market?

What are the potential challenges Granules India might face in scaling up production for Sodium Oxybate Extended-Release?

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Granules India to host analyst meet in London on June 23

0 min read Updated on 16 Jun 2026, 01:11 AM

Reviewed by

Suketu GScanX News Team

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Granules India Limited announced it will host an analyst and investor meeting in London on June 23 and 24, 2026, during the IIFL Invest India Conference. The company confirmed that no unpublished price-sensitive information will be disclosed. The schedule is tentative and subject to change.

*this image is generated using AI for illustrative purposes only.

Granules India Limited will host an analyst and investor meeting in London on June 23 and 24, 2026, as part of the IIFL Invest India Conference. The company stated that no unpublished price-sensitive information would be shared during these interactions.

Officials from the company will engage with analysts, investors, and funds through both one-to-one and group meetings. The schedule remains tentative and subject to change due to potential difficulties from the company or the attendees.

The disclosure was submitted to the National Stock Exchange of India Limited and BSE Limited in compliance with Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. Chaitanya Tummala, Company Secretary and Compliance Officer, signed the intimation on June 15, 2026.

The company has made its latest Investor Presentation available on its official website for stakeholders seeking additional context.