Granules India announced on Tuesday that its US subsidiary, Granules Pharmaceuticals, Inc (GPI), has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Lisdexamfetamine Dimesylate chewable tablets, a generic version of the well-known ADHD medication Vyvanse. Available in multiple strengths, this approval positions Granules to address a significant market gap as the drug is currently listed on the FDA’s Drug Shortages List. This milestone reinforces the company’s commitment to offering affordable, high-quality alternatives in critical therapeutic segments.

Approval for Lisdexamfetamine Dimesylate Chewable Tablets

Granules Pharmaceuticals, Inc (GPI) has secured USFDA approval for its generic Lisdexamfetamine Dimesylate chewable tablets.

The approved drug will be available in strengths of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg.
It serves as a therapeutic equivalent to Vyvanse, a branded medication developed by Takeda Pharmaceuticals.
This formulation is essential for treating attention-deficit hyperactivity disorder (ADHD) in both adult and pediatric patients aged six and above, as well as for addressing moderate to severe binge eating disorder (BED) in adults.

Addressing Critical Market Needs

The drug’s inclusion in the FDA Drug Shortages List highlights its significance in patient care.

Lisdexamfetamine chewable tablets have faced supply challenges, underscoring the urgent need for reliable and affordable alternatives.
With this approval, Granules India is poised to help fill this critical supply gap in the US pharmaceutical market.
The successful launch of this product could enhance patient access to vital ADHD treatments while simultaneously supporting Granules’ strategic growth in the US generics space.

Commitment to High-Quality and Affordable Medications

Krishna Prasad Chigurupati, Chairman and Managing Director of Granules Ltd, celebrated the approval as a key milestone for the company:

“This milestone reflects our unwavering commitment to addressing unmet patient needs by delivering high-quality, affordable medications,” he stated.
The approval strengthens the company’s focus on innovation, operational efficiency, and expanding its global presence in niche therapeutic areas.
Granules continues to advance its position as a reliable partner in the US generics market by introducing cost-effective solutions for essential medicines.

Strategic Market Opportunity for Granules

The approval represents a significant opportunity for Granules to capture a share in the ADHD medication market.

Vyvanse chewable tablets, the branded equivalent, dominate the ADHD treatment space, making this generic a key alternative for cost-conscious patients and healthcare providers.
Given the rising demand for ADHD and BED therapies in the US, this approval strategically positions Granules to meet growing market requirements.

Granules India’s Growing Momentum in the US Market

Granules Pharmaceuticals’ success reflects the parent company’s ongoing efforts to strengthen its footprint in the US.

With this approval, the company adds another critical medication to its expanding portfolio of USFDA-approved drugs.
Granules India’s focus on key therapeutic areas, regulatory compliance, and manufacturing excellence continues to deliver measurable success.
The company’s ability to secure approval for products currently listed on the Drug Shortages List further showcases its agility and operational strength.

Market Response to the Announcement

Following the news, Granules India’s stock price saw positive movement, reflecting investor confidence in the company’s growth trajectory.

Shares of Granules India were trading 1% higher at Rs 590 per share on the National Stock Exchange (NSE).
The approval is expected to boost the company’s revenue outlook, enhancing its overall financial health and market standing.

Future Prospects and Outlook

Granules India’s latest USFDA approval underscores its strategic focus on innovation and market expansion.

The company remains committed to identifying and addressing unmet patient needs with high-quality, cost-effective solutions.
By leveraging its strong manufacturing capabilities and regulatory expertise, Granules is well-positioned to deliver further value to patients, healthcare providers, and investors alike.

Conclusion: A Step Forward in Addressing ADHD Treatment Needs

Granules Pharmaceuticals’ USFDA approval for Lisdexamfetamine Dimesylate chewable tablets marks a significant achievement in the company’s growth strategy. By offering a critical generic alternative to Vyvanse, Granules is addressing supply shortages while expanding its presence in the US ADHD treatment market. This milestone reaffirms the company’s focus on providing affordable, high-quality medicines and highlights its capability to meet critical healthcare demands.