Investment19 Nov 2025, 11:25 am
Granules India Ltd Confident of Returning to Growth Trajectory in Formulation Business
AI Summary
Granules India Ltd has achieved multiple regulatory milestones, including successful U.S. FDA inspections of a greenfield formulation facility at Genome Valley, unlocking an additional 10 billion doses of formulation capacity. The company is also confident of securing new product approvals and enabling the Gagillapur site to fully support its return to the growth trajectory. The successful U.S. FDA inspection also establishes a second source supply of finished dosage and PFIs to the U.S. from India. The company's peptide CDMO platform, Ascelis Peptides, is also progressing well through its integration and capability building phase.
Key Highlights
- Granules India Ltd has achieved multiple regulatory milestones, including successful U.S. FDA inspections of a greenfield formulation facility at Genome Valley, unlocking an additional 10 billion doses of formulation capacity.
- The company is confident of securing new product approvals and enabling the Gagillapur site to fully support its return to the growth trajectory.
- The successful U.S. FDA inspection also establishes a second source supply of finished dosage and PFIs to the U.S. from India.
- The company's peptide CDMO platform, Ascelis Peptides, is also progressing well through its integration and capability building phase.
- Granules India Ltd is in an integration and infrastructure upgradation phase and expects to turn profitable in Q4 of this year.