Granules India Limited has announced a strategic expansion of its North American operations through the incorporation of a new wholly-owned subsidiary in Canada. This move marks a significant step in the company's international growth strategy.

Key Details of the Expansion

Strategic Implications

This corporate action represents a calculated move by Granules India to strengthen its foothold in the North American pharmaceutical market. By establishing a presence in Canada through its existing U.S. subsidiary structure, the company is positioning itself to:

1. Expand its geographical reach in North America
2. Potentially tap into the Canadian pharmaceutical market
3. Create a platform for future growth and business opportunities in Canada

Regulatory Compliance

Granules India has informed the National Stock Exchange of India Limited and BSE Limited about this development, in compliance with Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations 2015.

Outlook

While the newly incorporated Granules Pharmaceuticals Canada, Inc. has not yet commenced business operations, this move signals Granules India's commitment to international expansion and its focus on the North American market. This strategic initiative could potentially open up new avenues for product development, market access, and regulatory expertise in the North American continent.

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:

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:

1. 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.

2. 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.

3. 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.