Aragen Life Sciences, one of India’s leading contract research, development and manufacturing organisations (CRDMOs), commenced operations at Aragen OneHP, a high-potency development and manufacturing platform at its Nacharam campus in Hyderabad. The new facility strengthens the company’s capabilities in handling and manufacturing highly potent molecules, including cytotoxic payloads used in oncology.
With an integrated service model spanning early discovery through process development and multi-kilogram current Good Manufacturing Practice (cGMP) production, OneHP aims to help pharmaceutical customers advance complex drug development programmes and access clinical and commercial manufacturing capabilities.
Integrated High-Potency Manufacturing Capabilities
Spread across approximately 15,000 sq ft, Aragen OneHP operates one manufacturing line with a designed annual active pharmaceutical ingredient (API) capacity of 500–600 kg. The platform supports highly potent compounds, including cytotoxic molecules and targeted oncology therapies. Furthermore, OneHP provides an integrated manufacturing pathway covering multiple stages of drug development:
Small-scale chemistry synthesis: Up to 10 g
Non-GMP process development and scale-up: Up to 500 g
cGMP manufacturing: 500 g to 5 kg per batch
The facility incorporates advanced containment systems designed to handle compounds at occupational exposure limits of up to 10 ng/m³, subject to ongoing validation. These capabilities support the safe handling of highly potent active pharmaceutical ingredients throughout development and manufacturing.
Supporting Oncology Drug Development and Future Expansion
Highly potent molecules, particularly cytotoxic compounds, require specialised infrastructure, stringent containment measures and controlled manufacturing processes. By bringing synthesis, process development, scale-up and cGMP manufacturing together, OneHP aims to reduce the need for multiple service providers and streamline the transition from early-stage development to clinical and commercial supply. In addition, the platform establishes a foundation for Aragen’s future expansion into advanced drug modalities, including antibody-drug conjugates (ADCs) and peptide-drug conjugates (PDCs).
Aragen Expands Manufacturing and Development Investments
Aragen OneHP forms part of the company’s broader capacity expansion programme. Aragen invested more than ₹1,000 crore in capital expenditure over the three years ending March 2026, strengthening its capabilities across small molecules and biologics.
During this period, the company’s contract development and manufacturing business recorded a compound annual growth rate (CAGR) of 19%, while its contract research business grew at a CAGR of 12%. As of March 31, 2026, Aragen had installed small-molecule manufacturing capacity of 364 kilolitres across its Hyderabad and Visakhapatnam facilities.
Global Customer Base and Regulatory Credentials
Aragen serves pharmaceutical and biotechnology customers worldwide. In the financial year ending March 2026, nearly 95% of its revenue came from global customers. The company served 591 customers during the year, including 16 of the world’s top 20 pharmaceutical companies. Additionally, Aragen’s Hyderabad manufacturing and analytical operations hold accreditations from several international and national regulatory agencies, including the US Food and Drug Administration (USFDA), European Directorate for the Quality of Medicines & HealthCare (EDQM), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), South Korea’s Ministry of Food and Drug Safety (MFDS), Brazil’s health regulatory agency ANVISA, the World Health Organization (WHO) in Geneva and India’s Central Drugs Standard Control Organisation (CDSCO).
Aragen Highlights the Benefits of an Integrated Platform
Aniel Khubchandani, Chief Executive Officer – Small Molecules-CDMO at Aragen Life Sciences, said, “With OneHP, we are bringing discovery, development and cGMP manufacturing for highly potent molecules onto a more integrated platform. This can reduce handoffs between providers, while keeping process knowledge and programme context connected as a molecule moves from early development towards commercial supply.” As per the press release, with the launch of OneHP, Aragen Life Sciences is strengthening its high-potency manufacturing infrastructure in Hyderabad and expanding its ability to support pharmaceutical customers across the drug development lifecycle.
