HRV Pharma, SMS LifeSciences Partner to Scale Orphan and Specialty APIs

Under the agreement, the two companies will jointly undertake co-development of a multi-year pipeline of high-value specialty APIs, including orphan, ultra-rare and niche-therapeutic molecules. The partnership will cover end-to-end GMP development and commercial manufacturing, ranging from route scouting and process intensification to scale-up, validation and global supply.

The collaboration will also involve an integrated global regulatory strategy, including Drug Master File (DMF) filings across the US, EU, Latin America, MENA and APAC markets, supported by complete CMC documentation, stability data and validation packages. A forward-looking annual launch programme has been planned, targeting the introduction of five to seven new molecules every year across rare diseases, CNS disorders, metabolic conditions and other high-science therapeutic areas.

In addition, both companies will implement a harmonised quality and compliance framework designed to meet the expectations of global regulators such as the US FDA, EMA, PMDA and ANVISA.

Commenting on the partnership, Hari Kiran Chereddi, Managing Director and CEO, HRV Pharma, said the collaboration would accelerate HRV’s mission of building a next-generation Virtual API ecosystem capable of scaling high-value specialised APIs for global markets. He noted that SMS’s strength in chemistry and niche-therapeutic manufacturing, combined with HRV’s regulatory and commercial capabilities, creates a strong platform to address unmet needs in orphan and specialty care.

Praveen Talluri, Executive Director, SMS LifeSciences (now Haleos Labs), said the partnership aligns with the company’s long-term strategy of moving deeper into complex and high-value APIs serving rare and underserved therapeutic segments. He added that the collaboration would enable commercialisation of innovation at scale while strengthening SMS’s global footprint in orphan and niche therapeutics.

The partnership has already commenced with a structured pipeline of five initial orphan and niche therapeutic programmes, with additional molecules planned annually. HRV Pharma has already filed multiple US DMFs as part of the early phase of the collaboration.

Both organisations will jointly manage CMC documentation, stability studies, validation programmes and regulatory engagements, creating a seamless development-to-commercialisation pathway. The collaboration reinforces HRV’s vision of building an AI-enabled, asset-light pharmaceutical platform and SMS’s ambition to emerge as a preferred global partner for orphan and specialty API development.