Granules India gets USFDA tentative nod for amphetamine (2026)

What Granules India announced

Granules India Limited said its wholly owned US subsidiary, Granules Pharmaceuticals Inc. (GPI), has received tentative approval from the US Food and Drug Administration (USFDA) for an Abbreviated New Drug Application (ANDA) for Amphetamine Extended-Release (ER) Tablets. The company disclosed the update on Thursday, January 8, 2026. Along with the tentative approval, the USFDA determined the ANDA is eligible for 180 days of marketing exclusivity.

The announcement places Granules in the spotlight for another filing in the attention deficit hyperactivity disorder (ADHD) therapeutic area. The company positioned this as a “double regulatory win” in ADHD, following an earlier tentative approval for a related amphetamine product in late 2025. Granules India is headquartered in Hyderabad, Telangana, and operates across active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosage forms (FDs).

The product and where it fits in ADHD therapy

Granules said the approved ANDA is for Amphetamine ER Tablets in strengths of 5 mg, 10 mg, 15 mg, and 20 mg. These strengths target the same ADHD therapeutic category as branded amphetamine extended-release products such as Dyanavel XR. Dyanavel XR is described as an extended-release oral suspension marketed by Tris Pharma.

The company also clarified an important point on comparability: the amphetamine extended-release tablet competes within the same therapeutic category, but is not a dosage-form equivalent to the branded product referenced in the disclosure. That distinction matters in how investors and industry participants interpret substitution dynamics, product positioning, and the regulatory pathway for generics.

What “tentative approval” means

Tentative approval indicates that the ANDA meets USFDA requirements for quality, safety, and efficacy, but cannot yet be finally approved for marketing. The remaining barrier is typically related to patents or exclusivity associated with the reference-listed drug, or other regulatory constraints.

Granules also addressed how exclusivity should be read at this stage. It noted that exclusivity represents eligibility for first-to-file applicants and is granted only upon final approval and commercial launch, subject to patent resolution. In other words, the 180-day period is not automatic at the tentative stage, and timelines can shift depending on legal and regulatory outcomes.

Exclusivity eligibility and the 180-day window

The USFDA’s determination that the ANDA is eligible for 180 days of marketing exclusivity is a key feature of the filing. In practice, this provision can help early applicants compete more effectively during the initial generic entry period, if they reach final approval and launch conditions are met.

Granules’ statement emphasised the conditional nature of this benefit. Eligibility does not guarantee exclusivity will ultimately be granted. The company linked the outcome to final approval timing, commercial readiness, and patent or legal resolution.

Expected launch window flagged by the company

Based on patent tracking and industry estimates cited in the provided context, potential launch windows are expected between late 2026 and early 2027. Granules framed this range as subject to legal and regulatory outcomes, which is consistent with how tentative approvals typically translate into market entry.

This timeline framing matters for investors because it sets expectations that the product is not yet a near-term revenue driver. It also signals that the next set of catalysts may come from patent developments, the transition from tentative to final approval, and commercial planning updates.

Granules’ earlier ADHD-related tentative approval in 2025

Granules Pharmaceuticals Inc. also received tentative approval from the USFDA on December 22, 2025, for an ANDA for Amphetamine Extended-Release Orally Disintegrating Tablets (ODT). The company described this product as the generic equivalent of ADZENYS XR-ODT®.

The disclosed strengths for the ODT version were 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg. With the January 2026 update on amphetamine ER tablets, Granules has highlighted progress across more than one dosage form within the same broad therapeutic area.

Other US regulatory updates cited in the context

Beyond ADHD, the provided material references other US-facing milestones. Granules India Limited announced USFDA approval for its ANDA for Sildenafil for Oral Suspension, 10 mg/mL, filed by Granules Pharmaceuticals Inc.

The context also mentions regulatory milestones in Q2FY26, including US FDA approval for Metformin IR Tablets (PAI), Establishment Inspection Reports (EIRs) for the Bonthapally API Unit 1 and Granules Pharmaceutical Inc, and a GMP certificate for the Gagillapur facility from German authorities. The details in the material are limited, but they collectively indicate continued compliance activity and approvals across multiple sites and products.

Company footprint and contact details

Granules India Limited is described as an Indian pharmaceutical manufacturing company headquartered in Hyderabad, Telangana. Its business spans the manufacture and sale of finished dosage forms, pharmaceutical formulation intermediates, and active pharmaceutical ingredients. The company is also described as having a leadership position in generic drugs such as Paracetamol and Ibuprofen.

The registered office address provided is: 15th Floor, Granules Tower, Botanical Garden Road, Kondapur, Hyderabad. Corporate contact details listed include Tel: +91 40 30660000, Fax: +91 40 23115145, email: mail@granulesindia.com, and website: www.granulesindia.com. Media and investor contacts named in the material are Priyanka Chawla (Corporate Communications) at priyanka.chawla@granulesindia.com and Chaitanya Tummala (Company Secretary) at 040-69043614 and chaitanya.tummala@granulesindia.com.

Key facts table

Why this development matters for the stock-market narrative

For Granules, the update adds another data point on its US generics execution through GPI, especially in a therapeutic segment where regulatory timing, dosage-form strategy, and patent outcomes can influence launch opportunities. The company’s own caution on exclusivity makes the near-term interpretation clearer: this is a regulatory step forward, but commercial benefits depend on final approval and legal clarity.

At a sector level, the development fits a broader pattern in the Indian pharma space, where companies build US pipelines through multiple ANDAs and aim to strengthen compliance outcomes through inspections, EIRs, and GMP certifications. Granules’ disclosures across amphetamine products and other ANDAs such as sildenafil oral suspension and metformin IR add to the picture of a diversified US filing and approval track.

Conclusion

Granules India’s January 2026 disclosure centres on tentative USFDA approval for amphetamine ER tablets and eligibility for 180 days of marketing exclusivity, alongside an earlier tentative approval for an amphetamine ER ODT in December 2025. The company has indicated that exclusivity and launch timing depend on final approval and patent resolution, with potential launch windows expected between late 2026 and early 2027. Future updates are likely to be driven by regulatory progression from tentative to final approval and any clarity on patent or legal milestones tied to launch readiness.