India's HRV Pharma & Shodhana partner for next-gen APIs

 India’s first integrated Virtual API and Pharmtech company, announced a comprehensive, multi-year Contract Development & Manufacturing partnership with Shodhana Laboratories Private Limited, a Hyderabad-based USFDA-aligned API manufacturer, to co-develop, manufacture, and supply a curated pipeline of high-science APIs, including pharmaceutical-grade API’s primarily used in longevity biology, backed by a US Drug Master File (DMF).  

The collaboration aligns with India’s long-term vision to move up the pharmaceutical value chain, from volume-driven generics production to high-margin, innovation-led manufacturing. Official narratives from policymakers and industry bodies emphasise reducing import dependency, improving supply chain security, and enhancing global competitiveness. With increasing scrutiny on quality standards from regulated markets like the US and Europe, Indian firms are also investing heavily in compliance, advanced chemistry capabilities, and R&D-driven API development. 

According to Towards Healthcare, the Pharmaceutical Hot Melt Extrusion Market is projected to experience significant growth, with estimates suggesting the market size will increase from USD 40.76 billion in 2026 to approximately USD 62.11 billion by 2035, representing a compound annual growth rate (CAGR) of 4.79% from 2026 to 2035. Growth is driven by the increasing demand for advanced drug delivery systems and the need for improved bioavailability of poorly soluble drugs. Hot Melt Extrusion is a versatile processing technique used to create solid. The market is expanding due to the rising demand for enhanced drug solubility and bioavailability, and the adoption of a continuous manufacturing process. 

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, which is 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. 

Driving Innovation Through Collaboration 

Initiation of multiple development programs through partnership with both organizations working within a milestone-driven framework to accelerate execution. 

It aims to unlock new possibilities in complex molecule development by leveraging AI-enabled platforms, GMP manufacturing excellence, and global regulatory alignment, HRV Pharma and Shodhana Laboratories. 

A recent report by Towards Healthcare highlights that the Pharmaceutical Hot Melt Extrusion Market is witnessing growth due to demand for advanced drug delivery systems and the need for improved bioavailability and patient compliance. It enhances drug solubility, stability, and deliverability, making it a preferred technique for formulating poorly soluble API. 

North America is leading the market share, and the Asia Pacific is emerging as the fastest-growing region. Asia Pacific, including countries like China, India, and Southeast Asia, is rapidly expanding its pharmaceutical production capabilities, leading to a surge in demand for advanced extrusion technologies.