Aragen commissions $3 million formulations facility in Hyderabad

Aragen Life Sciences, a provider of contract research, development, and manufacturing services for the pharmaceutical, biotechnology, agrochemical, and animal health industries, has inaugurated its new formulations manufacturing facility in Hyderabad with a $3 million investment. 

The facility, located at the Mallapur Campus in Hyderabad, spans over 12,000 square feet, and is equipped to support the clinical manufacturing of various dosage forms, including oral solids, liquids, topicals, and films, the company said in a statement. 

This expansion bolsters Aragen's early-stage New Chemical Entity (NCE) development capabilities and enhances its flexibility to meet customer demands for clinical supplies in various dosage forms. Aragen can now provide comprehensive support for its customers' clinical programs, covering drug discovery to Phase I-III clinical supply of tablets, capsules, liquids, semisolids, and films for clinical use. 

The facility, the company said, boasts a wide range of formulation technologies, including wet granulation, roller compaction, film coating, spray drying, tableting, capsule filling, bottle filling, and blister packing. It has been strategically designed for future expansion, with plans to add nano-milling and hot melt extrusion capabilities next year to maintain Aragen's position at the forefront of pharmaceutical innovation.  

This facility has received approvals from Indian regulatory authorities, including the Central Drugs Standard Control Organization (CDSCO) and the Drug Control Administration (DCA), Aragen said.

Furthermore, it has successfully passed multiple client audits, affirming its commitment to upholding the highest quality and compliance standards. With flexible batch sizes, it can accommodate 1,000 to 100,000 doses for solid orals and 1 to 100 litres for liquids, managed by a dedicated team of approximately 60 staff members. 

"With the expansion of the Hyderabad facility, we can offer our customers an even broader range of services, from early-stage development to clinical manufacturing, all from a co-located facility," said Manni Kantipudi, CEO of Aragen Life Sciences. "We look forward to leveraging these capabilities to support our customers' drug development needs, enabling them to bring life-changing medicines to patients worldwide," Kantipudi added. 

Aragen has been providing Formulation R&D services at its 10,000 sq ft research facility since 2018. The establishment of the Formulation manufacturing facility indicated a strategic move to reinforce its position as a comprehensive 'one-stop solution provider' for the life sciences industry.