Hyderabad, Mar 30: HRV Global Life Sciences, India’s first integrated Virtual API and Pharmtech company, has announced a comprehensive multi-year Contract Development and Manufacturing (CDMO) partnership with Shodhana Laboratories Private Limited to co-develop, manufacture, and supply a curated pipeline of high-science pharmaceutical APIs.
The collaboration will focus on advancing pharmaceutical-grade APIs, including those primarily used in longevity biology, supported by a US Drug Master File (DMF). With this development, HRV becomes the holder of the first and only active Indian DMF for this specific pharmaceutical API category.
The partnership combines HRV’s global market access across 50+ countries, its AI-enabled Virtual API platform, and regulatory DMF capabilities with Shodhana’s expertise in process chemistry, high-purity synthesis, and GMP-compliant infrastructure. Together, the companies aim to create a seamless development-to-commercialization pathway for next-generation molecules in precision medicine.
Under the agreement, both organizations will jointly undertake:
- Development and US DMF filing for pharmaceutical-grade APIs associated with cellular energy, DNA repair, and aging—emerging as regulated therapeutic solutions in oncology supportive care, neurodegeneration, and longevity medicine
- A pipeline of five advanced APIs across CNS, rare/orphan diseases, and metabolic and neurological segments, targeting regulated markets in the USA and Europe
- End-to-end GMP manufacturing, CMC documentation, stability studies, and validation aligned with global regulatory standards including USFDA, EMA, PMDA, and ANVISA
- Global DMF filings across key regions including the US, EU, LATAM, MENA, and APAC, led by HRV’s regulatory framework
- Implementation of a unified quality, compliance, and audit-readiness system to meet stringent global benchmarks
Hari Kiran Chereddi, MD & CEO of HRV Pharma, said,
“The API’s launch is not a wellness trend—it marks the beginning of a new pharmaceutical category. Filing a US DMF is a strategic step toward building the next decade of medicine. By combining Shodhana’s synthesis precision with our regulatory and commercial platform, India is now positioned to deliver this molecule at the quality standards required for global drug development.”
Nikhil Thota, Director of Shodhana Laboratories, added,
“Manufacturing pharmaceutical-grade APIs demands the highest level of synthesis precision and quality systems. This partnership with HRV enhances our global regulatory reach and positions us at the forefront of high-science API manufacturing for regulated markets worldwide.”
The partnership has already commenced with five active development programs, with both companies jointly managing regulatory strategy and execution under a structured, milestone-driven framework.
This collaboration reinforces HRV’s mission to build an AI-enabled, asset-light pharmaceutical platform while strengthening Shodhana’s position as a preferred global partner for precision and specialty API development.
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