Granules India Reports Strong Q2 Growth, Secures FDA Approval for New Facility
Granules India Limited reported robust Q2 financial results with revenue increasing 34% year-over-year to 12,970.00. Gross margin improved by 368 bps to 65.70%, while EBITDA grew 36.80% to 2,782.00. The company made significant regulatory progress, including FDA discussions for its Gagillapur facility and approval for its Genome Valley facility. Strategic initiatives include European expansion, development of a peptide CDMO platform, and growth in controlled substances business. The company expects continued growth driven by new facility operations and portfolio diversification.

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Granules India Limited , a prominent pharmaceutical company, has reported robust financial results for the second quarter, marking significant progress in its growth trajectory and regulatory compliance efforts.
Financial Highlights
Granules India achieved impressive financial results in Q2:
| Metric | Q2 | Q2 Previous Year | YoY Growth |
|---|---|---|---|
| Revenue | 12,970.00 | 9,666.00 | 34.00% |
| Gross Margin | 65.70% | 62.02% | 368 bps |
| EBITDA | 2,782.00 | 2,033.00 | 36.80% |
| EBITDA Margin | 21.50% | 21.08% | 42 bps |
The company's strong performance was primarily driven by growth in its formulations business in North America and Europe. The gross margin improvement of 368 basis points year-on-year was attributed to enhanced operational efficiency and a favorable product mix.
Regulatory Milestones
Granules India has made significant strides in regulatory compliance and facility approvals:
Gagillapur Facility: The company has secured a meeting with the U.S. FDA to discuss remediation efforts at its Gagillapur facility. Granules continues to submit monthly progress reports and has received no concerns from the FDA regarding the adequacy or pace of its corrective actions.
Genome Valley Facility: The company's greenfield GLS facility at Genome Valley, Hyderabad, received U.S. FDA approval for a product following a Pre-Approval Inspection (PAI). This marks the first FDA approval for the GLS site, strengthening Granules' finished dosage capabilities and enabling multi-site manufacturing.
Other Facilities: The company's GPI site in Chantilly, Virginia, and API Unit 1 facility at Bonthapally have both received positive outcomes from recent FDA inspections.
Strategic Developments
Granules India is focusing on several strategic initiatives to drive future growth:
- European Expansion: The company has incorporated a German subsidiary to support its growth plans in the European Union market.
- Peptide CDMO Platform: Ascelis Peptides, built on Senn Chemical's Swiss legacy, is progressing through its integration and capability-building phase. The company expects this segment to turn profitable in the future.
- Controlled Substances: Granules anticipates significant growth in its controlled substances business over the next 3 to 10 years, with products filed until 2035.
Outlook
Dr. Krishna Prasad Chigurupati, Chairman and Managing Director, expressed confidence in the company's future, stating, "We are entering the phase of reviving our growth with a stronger quality foundation, expanded capacity, and a more diversified portfolio."
The company expects near-term momentum to be driven by the ramp-up of prescription supplies from the Genome Valley facility, continued growth from U.S. manufacturing operations, and expected normalization of operations at Gagillapur post-remediation.
Granules India remains committed to its sustainability goals and disciplined execution, aiming to deliver sustained value to all stakeholders in the coming quarters.
Historical Stock Returns for Granules
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| -0.61% | +2.87% | -1.38% | +9.05% | +0.97% | +47.64% |
















































