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HRV Global Life Sciences Partners with SMS LifeSciences (Haleos Labs) to Build Orphan & Specialty API Pipeline

21 Jan 2026
Admin
News Article

HRV Global Life Sciences Partners with SMS LifeSciences (Haleos Labs) to Build Orphan & Specialty API Pipeline

HRV Global Life Sciences, an integrated virtual API and pharmtech company, has entered into a multi-year, exclusive strategic development partnership with SMS LifeSciences (now Haleos Labs), a specialty API and intermediates manufacturer with a 25-year track record in global quality and compliance.

The collaboration is focused on the development, scale-up, and GMP manufacturing of orphan, ultra-rare, and niche-therapeutic APIs for regulated and semi-regulated markets worldwide.

What each partner brings?

HRV Global Life Sciences

Asset-light, digital virtual API platform
Commercial and market access footprint across 50+ countries
Global regulatory execution, including DMF strategy and lifecycle management

SMS LifeSciences (Haleos Labs)

Deep synthetic chemistry and process development expertise
WHO-GMP–aligned manufacturing infrastructure
Proven experience in complex and specialty API production

Scope of the collaboration

Co-development of a multi-year pipeline of high-value specialty APIs
- Focus areas include orphan, ultra-rare, and niche therapeutic segments
End-to-end GMP execution
- Route scouting and process optimization
- Scale-up, validation, and commercial manufacturing
Integrated global regulatory strategy
- DMF filings across US, EU, LATAM, MENA, and APAC
- Full CMC, stability, validation, and technical documentation
Structured annual launch program
- 5–7 new APIs per year
- Targeting rare diseases, CNS disorders, metabolic conditions, and other high-science indications
Unified quality and compliance framework
- Designed to meet expectations of US FDA, EMA, PMDA, ANVISA, and other major regulators

Early traction

Partnership launched with five initial orphan/niche API programs
Multiple US DMFs already filed by HRV as part of the collaboration
Joint ownership of CMC documentation, stability programs, validation activities, and regulatory interactions

Leadership perspective

Hari Kiran Chereddi, MD & CEO, HRV Global Life Sciences, said the partnership accelerates HRV’s vision of building a next-generation virtual API ecosystem, combining regulatory depth, speed, and global scalability to address unmet needs in orphan and specialty care.

Praveen Talluri, Executive Director, SMS LifeSciences (Haleos Labs), noted that the alliance supports SMS’s strategic shift toward complex, high-value APIs, enabling global commercialization while expanding its footprint in orphan and underserved therapeutic areas.

Why this matters?

Signals a shift toward platform-driven, asset-light API development
Aligns chemistry depth with global regulatory and market execution
Positions both companies as long-term partners in orphan and specialty API supply chains
Reduces development friction from route design to commercial launch