HRV Pharma is pleased to announce a multi-year strategic partnership with Haleos Labs (formerly SMS LifeSciences) to develop and manufacture orphan and niche active pharmaceutical ingredients (APIs). This exclusive collaboration aims to address critical gaps in the global supply of complex APIs for rare diseases and specialized therapies.
By combining HRV’s global commercialization and regulatory execution expertise with Haleos Labs’ proven WHO-GMP manufacturing capabilities, the partnership delivers an end-to-end solution for orphan and niche API programs—from early development through commercial supply.
The Orphan API Challenge
Orphan drugs and niche therapeutics represent a fast-growing yet underserved segment of the pharmaceutical market. These programs face unique technical and commercial challenges, including:
- Highly complex chemistry requiring specialized process development
- Limited patient populations that strain traditional manufacturing economics
- Accelerated regulatory timelines driven by unmet medical needs
- Global filing complexity across multiple jurisdictions, including FDA, EMA, and ANVISA
The HRV - Haleos partnership is designed to systematically overcome these barriers and enable faster, more reliable access to critical therapies.
Partnership Scope and Deliverables
Technical Capabilities
- Route scouting, process development, and optimization for complex orphan molecules
- GMP manufacturing from clinical to commercial scale
- Full CMC package including stability, validation, and impurity control
- Process intensification for cost-effective scale-up
Commercial Reach
- Coordinated regulatory filings across 50+ countries
- Master plan submissions for US, EU, LATAM, and APAC markets
- Supply-chain orchestration from development through commercial launch
Pipeline Commitment
The collaboration targets the development of 5–7 new specialty APIs annually across key therapeutic areas, including:
- Rare diseases
- Oncology
- Central nervous system (CNS) disorders
- Metabolic diseases
- Ultra-rare conditions
Strategic Advantages for Partners
- Accelerated timelines: Optimized process development pathways for faster progression
- Lower manufacturing costs: GMP processes designed for efficiency from day one
- Simplified regulatory strategy: Coordinated global filing and submission planning
- Reduced supply-chain risk: Single-point accountability across development and supply
- Specialized expertise: Dedicated focus on orphan and niche API programs
Why This Partnership Matters
For Patients: Faster access to life-changing therapies for rare and ultra-rare diseases.
For Pharmaceutical Companies: De-risked development, predictable timelines, and global commercialization reach.
For HRV Pharma: Strengthens leadership in complex API commercialization and orphan drug enablement.
Next Steps
HRV Pharma is now accepting partnership inquiries for orphan and niche API development programs. Companies seeking to accelerate their complex-molecule pipelines are invited to contact our team.
Email: sales@hrvpharma.com
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