Two Hyderabad based pharmaceutical companies, HRV Pharma and Shodhana Laboratories, have launched a strategic CDMO alliance to jointly develop and commercialize advanced Active Pharmaceutical Ingredients (APIs), combining AI-driven virtual platforms with precision manufacturing capabilities for regulated global markets.
Glimpse:
The partnership focuses on co-developing high science APIs, starting with the filing of a US Drug Master File (DMF) for a key pharmaceutical grade master coenzyme used in cellular energy, DNA repair, and ageing related processes. It also includes a pipeline of five APIs targeting central nervous system disorders, rare diseases, metabolic conditions, and neurological issues, with identified customers in the US and Europe.
Hyderabad based HRV Pharma and Shodhana Laboratories have announced a strategic alliance in the Contract Development and Manufacturing Organization (CDMO) space to accelerate the development of next-generation Active Pharmaceutical Ingredients. This collaboration brings together HRV Pharma’s AI-enabled virtual drug development platform, strong regulatory expertise, and market access in over 50 countries with Shodhana Laboratories’ capabilities in process chemistry, high-purity synthesis, and GMP-compliant manufacturing.
The alliance aims to support the growing demand for specialized APIs in areas such as precision medicine, oncology supportive care, and neurodegenerative conditions. A key highlight of the partnership is the joint development and planned US Drug Master File filing for a pharmaceutical-grade master coenzyme involved in cellular energy production, DNA repair, and ageing processes. This molecule is being positioned as a regulated therapeutic rather than a wellness supplement. HRV Pharma already holds the first active Indian DMF in this API category.
In addition to the flagship molecule, the two companies have initiated work on a pipeline of five APIs focused on central nervous system disorders, rare diseases, metabolic conditions, and neurological issues. Both partners will jointly handle regulatory strategies, documentation, and validation activities under a milestone based execution model. The collaboration is expected to enable faster delivery of high quality APIs suitable for regulated markets in the US and Europe, where customer interest has already been identified.
This alliance reflects a broader industry shift toward high science APIs beyond traditional generics, leveraging India’s strengths in innovation and manufacturing to meet evolving global pharmaceutical needs.
“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.”
By
HB Team
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