The partnership has already launched with five active development programs, with both organizations jointly managing regulatory strategy and documentation under a structured, milestone-gated framework
HRV Global Life Sciences (HRV Pharma), India's first integrated Virtual API and Pharmtech company, has 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).
This makes HRV the holder of the first and only active Indian DMF in this product as a pharmaceutical API.
The collaboration brings together HRV's global market access across 50+ countries, AI-enabled Virtual API platform and regulatory DMF engine, with Shodhana's deep process chemistry, high-purity synthesis expertise and GMP infrastructure creating a seamless development-to-commercialization pathway for molecules at the frontier of precision medicine.
Speaking on the partnership, Hari Kiran Chereddi, MD & CEO, HRV Pharma said, "The API’s launch is not a wellness trend, it is the beginning of a pharmaceutical category. Filing a US DMF for pharmaceutical API’s is HRV's signal that we are building for the next decade of medicine. Shodhana's synthesis precision, combined with our global regulatory and commercial platform, means India can now supply this molecule at the quality level that drug development demands alongside a broader pipeline of high-science APIs that define where pharma is headed."
Nikhil Thota, Director, Shodhana Laboratories said, "Manufacturing pharmaceutical-grade API’s, and other products demands synthesis precision and quality systems at the highest tier of API chemistry. This is precisely where Shodhana excels. Partnering with HRV gives our pipeline the global regulatory infrastructure and commercial reach it deserves, and positions us at the forefront of high-science API manufacturing for regulated markets worldwide."
The partnership has already launched with five active development programs, with both organizations jointly managing regulatory strategy and documentation under a structured, milestone-gated framework.
This collaboration reinforces HRV's broader mission of building an AI-enabled, asset-light pharmaceutical platform and Shodhana's emergence as a preferred partner for precision and specialty API development at global scale.
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