HRV Pharma, Shodhana join hands to build next-gen API pipeline for global markets

Multi-year CDMO partnership combines AI-led virtual development, precision chemistry and GMP manufacturing to accelerate five high-science APIs across regulated markets

HRV Pharma has recently entered into a multi-year contract development and manufacturing (CDMO) alliance with Shodhana Laboratories to co-develop and commercialise a portfolio of next-generation active pharmaceutical ingredients (APIs), marking a strategic move into high-science, specialty molecules. 

The collaboration blends HRV Pharma’s AI-enabled virtual API platform, global regulatory execution and market access across more than 50 countries with Shodhana’s strengths in process chemistry, high-purity synthesis and USFDA-aligned GMP manufacturing infrastructure. Together, the companies aim to create a seamless pathway from early development to global commercial supply. 

A key milestone under the partnership will be the development and US Drug Master File (DMF) submission for a pharmaceutical-grade API linked to cellular energy, DNA repair and ageing biology, a molecule increasingly being explored for oncology supportive care, neurodegeneration and longevity-focused therapies. The alliance also covers a pipeline of five advanced APIs spanning CNS, rare diseases, metabolic and neurological disorders, with identified customers in the US and Europe. 

Beyond development, the scope includes end-to-end GMP manufacturing, CMC documentation, validation, stability studies and global regulatory filings aligned with US FDA, EMA and other international standards. The structured, milestone-driven framework is expected to shorten timelines while ensuring audit-ready compliance for regulated markets. 

The partnership reflects a broader shift in India’s API industry from scale-led generics manufacturing to innovation-driven, precision and specialty API development, particularly in emerging areas such as longevity biology and precision medicine. By combining digital platforms with advanced chemistry capabilities, both companies are positioning themselves to capture higher-value opportunities in global pharma supply chains.