Granules India Ltd. Confident of Returning to Growth Trajectory in Formulations Business
Granules India Ltd. has achieved multiple regulatory milestones, including successful FDA inspections at its US-based GP site and API Unit I facility at Bonthapally. The company's new formulations facility at Genome Valley underwent a successful first-ever FDA pre-approval inspection. These inspections unlock an additional 10 billion doses of formulations capacity, establishing a second source supply of finished dosages and PFIs to the US from India. The company is also expecting swift overcoming of production slowdown from additional protocols, securing new product approval, and enabling the site to fully support its return to the growth trajectory. Additional growth will come from CNS ADHD segment from the GPI facility in the US, scale-up of large-volume products in the US and Europe, moving up the value chain in Europe, and oncology capacity monetization from Unit V. The company has also taken a significant step into high-growth peptide therapeutics and CDMO space with Senn Chemicals and Ascelis Peptides.
Key Highlights
- Successful FDA inspections at multiple sites, reaffirming commitment to strengthening quality and compliance
- Additional 10 billion doses of formulations capacity, a 40% increase over existing capacity
- Expected swift overcoming of production slowdown from additional protocols and new product approval at Gagillapur
- Strategic expansion into high-value segments such as peptides through Senn Chemicals and Ascelis Peptides
- Commitment to sustainability, named to the 2024 CDP Supplier Engagement A-List for Leadership in Supplier Climate Action and Value Chain Emissions Management