Hyderabad Pharma Firms Join Forces for Specialized Drug Development
Two Hyderabad-based pharmaceutical companies have announced a major strategic partnership. HRV Global Life Sciences, operating as HRV Pharma, has entered into a comprehensive multi-year agreement with Haleos Labs. This collaboration aims to accelerate the development and manufacturing of specialized active pharmaceutical ingredients.
Focus on Orphan and Niche Therapeutics
The partnership specifically targets orphan-drug APIs and niche therapeutic ingredients. These will serve both regulated and semi-regulated markets worldwide. The alliance brings together complementary strengths from both organizations.
Haleos Labs contributes its WHO-GMP-aligned systems and extensive experience in specialty API production. The company, formerly known as SMS LifeSciences Limited, brings twenty-five years of manufacturing legacy to the table.
HRV Pharma offers global market access capabilities and regulatory execution expertise. The company follows an asset-light model and describes itself as India's first integrated virtual API and pharmtech company.
Ambitious Development Pipeline
The collaboration will pursue a multi-year pipeline of high-value specialty APIs. These span orphan, ultra-rare, and niche therapeutic categories. The partnership covers end-to-end development and commercial manufacturing activities.
Key areas of cooperation include:
- Route scouting for new molecules
- Process intensification techniques
- Scale-up operations
- Validation procedures
- Global supply chain management
The companies expect to introduce five to seven new molecules each year. These will target therapeutic areas including rare diseases, central nervous system disorders, and metabolic conditions. Other high-science therapeutic segments will also receive attention.
Integrated Regulatory Strategy
Both players plan to implement an integrated regulatory approach. This strategy includes Drug Master File filings across multiple regions. Targeted markets include the United States, European Union, Latin America, MENA countries, and APAC nations.
The regulatory effort will be supported by complete CMC documentation. Stability studies, validation programs, and technical documentation will also form part of this comprehensive approach. Multiple US DMFs have already been filed from early collaboration efforts.
Leadership Perspectives
Hari Kiran Chereddi, Managing Director and CEO of HRV Pharma, shared his vision for the partnership. He stated that this collaboration advances HRV's goal of building a next-generation virtual API ecosystem. The aim is to scale specialized APIs globally through their digital platform.
Praveen Talluri, Executive Director of Haleos Labs, emphasized the strategic importance of this move. He noted that the collaboration supports the company's transition into complex, high-value APIs. These serve underserved market segments that require specialized pharmaceutical solutions.
Initial Progress and Future Plans
The partnership has already begun with five initial orphan and niche programs. Additional molecules are planned for introduction annually. Both organizations will jointly manage various aspects of the collaboration.
Key joint management areas include:
- CMC documentation processes
- Stability study protocols
- Validation program implementation
- Regulatory interactions with authorities
HRV Pharma plans to combine its digital platform and commercial reach across more than fifty countries with Haleos Labs' chemistry expertise. This strategic combination creates a powerful force in the specialized pharmaceutical ingredients market.
