Aragen, a Contract Research Development and Manufacturing Organization (CRDMO), has announced that it will operationalize its formulation manufacturing facility in the Mallapur campus, Hyderabad, India by January 2023.
 
The 12,000 ft² new facility will strengthen the company’s ability to deliver clinical supplies to customers through its integrated drug substance and drug product development and manufacturing.
 
The new plant will include a wide range of dosage form capabilities for oral solids, liquids, topicals, films, and manufacturing technologies for granulation, film coating, spray drying, tableting – with expansion plans already in place to add nano milling and hot melt extrusion capabilities.
 
These new capabilities at the Mallapur Campus will further enhance Aragen’s New Chemical Entity (NCE) early-stage development offerings, providing customers the convenience to discover and develop drugs from a co-located facility. It will provide greater flexibility to deliver customers’ clinical supply needs in multiple dosage forms, with process technologies and flexible batch sizes as low as 1000 units to as high as 100000 units.
 
Speaking on the development, Manni Kantipudi, CEO, Aragen Life Sciences, said, “Aragen is investing in expanding capacities, extending capabilities and widening its geographic footprint to meet the needs of the global bio-pharma industry. We understand that our customers rely on our expertise, track record, and solution offerings. With this facility, we will consolidate our drug product development solution offerings and strengthen our position as a one-stop shop for all their needs – transforming ideas into solutions for better health.”
 
When complete and fully operational, Aragen will support its customers with cGMP manufacturing and phase I-III clinical supplies of tablets, capsules, liquids, semisolids and films. The facility will offer purpose-built manufacturing suites to support wet granulation, roller compaction, fluid bed coating, spray drying, micronisation, nano-milling, tableting, capsule filling, film coating and packaging processes
 
Ramesh Subramanian, chief commercial officer, Aragen Life Sciences, said, “The formulation manufacturing facility in Hyderabad is a significant development for us. The new capacity will allow us to address the increasing interest from our customers for integrated development solutions. It also fits in well with our stated vision of becoming the ‘R&D partner of choice’ for our customers. With this drug product facility and our recent acquisition of Intox – to provide safety assessment services – we can now assist our partners from Hit through Clinical Proof of Concept-Phase IIB, accelerating their journey towards impacting patients.”