Granules India reported strong Q2 FY26 results, with revenue reaching ₹12,970 million, a 34% increase compared to Q2 FY25. The company is in the final stages of remediation at its Gagillapur facility following the August 24 U.S. FDA inspection and subsequent warning letter. A meeting with the FDA has been scheduled for January 2026. The company anticipates returning to its growth trajectory for formulation business from India.
Financial Performance
Granules India announced its financial results for Q2 FY26, highlighting significant growth:
- Revenue: ₹12,970 million (Up 34% YoY)
- Gross Margin: 65.7% (Improved by 368 basis points YoY)
- EBITDA: ₹2,782 million (21.5% of sales)
- R&D Expenses: ₹705 million (5.4% of sales)
The company’s revenue growth was primarily driven by its formulation business in North America and Europe.
Gagillapur Facility Remediation
Granules India is nearing completion of its remediation efforts at the Gagillapur facility. The company has reached the eligibility milestone for a request for meeting and reinspection and has initiated formal engagement with the FDA. A meeting with the FDA is scheduled for January 2026.
The Gagillapur site has received a GMP certificate from German authorities. It has completed eight customer audits with no critical observations and received the UL certificate in the last quarter. The facility is now cleared by German and Danish authorities, with Denmark granting an EU GMP certificate in July 2025.
Other Regulatory Milestones
Across the company’s network, multiple regulatory milestones have been achieved:
- The U.S. FDA issued an Establishment Inspection Report for GPI site (Chantilly, Virginia).
- API Unit 1 facility at Bonthapally received an EIR and was classified as VAI by the FDA.
- Greenfield GLS facility at Genome Valley, Hyderabad, received U.S. FDA approval for a product.
Ascelis Peptides (CDMO Platform)
The peptide CDMO platform, Ascelis Peptides, is progressing through its integration and capability building phase. The company expects Ascelis to turn profitable in Q4 of this year and is targeting FY27 as the first fully synergized and profitable year.
Looking Ahead
Granules India anticipates returning to its growth trajectory for the formulation business from India, free from delivery constraints. The company expects growth from CNS-ADHD segment from its GPI facility in the U.S., scale-up of large volume products in the U.S. and Europe, and monetization of oncology capacity from Unit 5 in Vizag.
Source: BSE
