HRV Pharma and Haleos Labs Form Strategic CDMO Alliance to Accelerate Orphan Drug API Development
核心洞察
HRV Global Life Sciences (搜索) and SMS LifeSciences (搜索) (now Haleos Labs (搜索)) have established a comprehensive multi-year strategic partnership focused on developing orphan drug and niche therapeutic APIs for global markets.
The collaboration combines HRV's worldwide market access across 50+ countries and Virtual API platform with SMS's chemistry capabilities and WHO-GMP aligned manufacturing systems.
The partnership has launched with five initial orphan/niche therapeutic programs and plans to introduce 5-7 new molecules annually across rare diseases (搜索), CNS disorders (搜索), and metabolic conditions (搜索).
HRV Global Life Sciences (搜索) (HRV Pharma (搜索)), India's first integrated Virtual API and Pharmtech company, has announced a comprehensive multi-year strategic development partnership with SMS LifeSciences (搜索) (now Haleos Labs (搜索)) Limited, marking a significant alliance in the orphan drug and specialty API development space. The exclusive partnership focuses on the development, scale-up and GMP manufacturing of multiple orphan-drug and niche-therapeutic APIs for regulated and semi-regulated markets.
Strategic Alliance Framework
The collaboration brings together HRV's worldwide market access, commercial footprint across 50+ countries, and its digital, asset-light Virtual API platform, with SMS's deep chemistry capabilities, WHO-GMP aligned manufacturing systems, and proven track record in specialty API production spanning twenty-five years.
Under the agreement, both companies will jointly execute co-development of a multi-year pipeline of high-value specialty APIs, including orphan, ultra-rare and niche-therapeutic categories. The partnership encompasses end-to-end GMP development and commercial manufacturing from route scouting and process intensification to scale-up, validation and global supply.
Regulatory and Development Strategy
The alliance includes an integrated global regulatory strategy, featuring DMF filings across US, EU, LATAM, MENA & APAC supported by complete CMC, stability, validation and technical documentation. A harmonized quality, compliance and audit-readiness framework has been engineered to meet the stringent expectations of USFDA, EMA, PMDA, ANVISA and other regulatory authorities.
The partnership features a forward-looking annual launch program, introducing 5-7 new molecules every year across rare diseases (搜索), CNS disorders (搜索), metabolic conditions (搜索) and high-science therapeutic spaces. Both organizations will jointly manage CMC documentation, stability studies, validation programs and global regulatory interactions, creating a seamless development-to-commercialization pathway.
Initial Pipeline and Implementation
The partnership has already launched with a structured pipeline of five initial orphan/niche therapeutic programs, with additional molecules planned each year under a unified annual development framework. Multiple US DMFs have already been filed by HRV Pharma (搜索) as a result of the partnership between the two organizations.
"This collaboration accelerates HRV's mission to build a next-generation, Virtual API ecosystem that scales high-value, specialized APIs to global markets," said Hari Kiran Chereddi, MD & CEO of HRV Pharma (搜索). "SMS's strength in chemistry, quality and niche-therapeutic manufacturing, combined with HRV's global regulatory and market expansion engine, creates a powerful platform to address unmet needs in orphan and specialty care with speed, reliability and regulatory depth."
Praveen Talluri, Executive Director of SMS LifeSciences (搜索) (now Haleos Labs (搜索)) added, "Partnering with HRV aligns with our long-term vision of moving deeper into complex, high-value APIs that serve rare and underserved therapeutic segments. With HRV's global reach and regulatory expertise, and our manufacturing and chemistry capabilities, this partnership enables us to commercialize innovation at scale and deliver world-class solutions to global pharma while expanding our presence in niche and orphan therapeutic areas."
Strategic Positioning
This collaboration reinforces HRV's broader mission of building an AI-enabled, asset-light pharmaceutical platform, and SMS's ambition to emerge as a preferred partner for orphan, specialty and niche therapeutic API development at global scale. The alliance represents a significant step in addressing the complex manufacturing and regulatory challenges associated with orphan drug development while leveraging the combined expertise of both organizations to serve underserved therapeutic segments.