HYDERABAD: HRV Global Life Sciences (HRV Pharma) entered into a comprehensive, multi-year strategic development partnership with Haleos Labs (formerly SMS LifeSciences Limited) to accelerate the development and GMP manufacturing of orphan-drug and niche-therapeutic active pharmaceutical ingredients (APIs) for regulated and semi-regulated markets.Haleos Labs will bring its WHO-GMP-aligned systems and experience in speciality API production, while HRV will contribute global market access and regulatory execution capabilities.The alliance will jointly pursue a multi-year pipeline of high-value speciality APIs spanning orphan, ultra-rare and niche therapeutic categories. The collaboration will cover end-to-end development and commercial manufacturing, including route scouting, process intensification, scale-up, validation and global supply.They expect to introduce 5 to 7 new molecules each year, targeting rare diseases, central nervous system disorders, metabolic conditions and other high-science therapeutic areas.The 2 players also plan to take up an integrated regulatory strategy, including Drug Master File (DMF) filings across the US, EU, Latin America, MENA and APAC, supported by complete CMC, stability, validation and technical documentation.HRV Pharma, which follows a unique asset-light model and claims to be India’s first integrated virtual API and pharmtech company, plans to combine its digital, asset-light platform and commercial reach across over 50 countries with Haleos Labs’ chemistry expertise and 25-year manufacturing legacy as part of this strategic collaboration.Hari Kiran Chereddi, MD and CEO of HRV Pharma, told TOI that the partnership will advance HRV’s goal of building a next-generation virtual API ecosystem to scale specialised APIs globally. Praveen Talluri, Executive Director of Haleos Labs, said the collaboration will support the company’s move into complex, high-value APIs serving underserved segments.The partnership began with 5 initial orphan and niche programmes, with additional molecules planned annually. HRV said multiple US DMFs were already filed stemming from early collaboration, and both organisations will jointly manage CMC documentation, stability studies, validation programmes and regulatory interactions.
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