To fast-track orphan drug and niche API development
HRV Global Life Sciences announced a comprehensive, multi-year strategic development partnership with SMS LifeSciences (now Haleos Labs), an API and intermediate manufacturers with a twenty-five-year legacy of global quality and compliance.
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. The collaboration brings together HRV’s world-wide 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.
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
End-to-end GMP development and commercial manufacturing — from route scouting and process intensification to scale-up, validation and global supply
Integrated global regulatory strategy, including DMF filings across US, EU, LATAM, MENA & APAC supported by complete CMC, stability, validation and technical documentation
A forward-looking annual launch program, introducing 5–7 new molecules every year across rare diseases, CNS disorders, metabolic conditions and high-science therapeutic spaces
A harmonised quality, compliance and audit-readiness framework, engineered to meet the stringent expectations of USFDA, EMA, PMDA, ANVISA and other regulatory authorities
Hari Kiran Chereddi, MD and CEO, HRV Pharma, said, “This collaboration accelerates HRV’s mission to build a next-generation, Virtual API ecosystem that scales high-value, specialized APIs to global markets. 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 (now Haleos Labs) 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.”
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 DMF’s have already been filed by HRV Pharma as a result of fledging partnership between the two organisations.
Both organizations will jointly manage CMC documentation, stability studies, validation programs and global regulatory interactions, creating a seamless development-to-commercialisation pathway.
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.
