Aragen has commissioned its new formulations manufacturing facility in Hyderabad, India. This facility, set up at an investment of $3 million, is located at the Mallapur Campus in Hyderabad and spans over 12,000 square feet area. The company informed that it is equipped to support the clinical manufacturing of a wide range of dosage forms, including oral solids, liquids, topicals, and films.
Manni Kantipudi, CEO, Aragen Life Sciences, commented, “With this expansion, we can offer our customers an even broader range of services, from early-stage development to clinical manufacturing, all from a co-located facility. We look forward to leveraging these capabilities to support our customers’ drug development needs, enabling them to bring life-changing medicines to patients worldwide.”
A company statement gave details about the key highlights of the facility such as that:
- The facility is equipped with a suite of formulation technologies, including wet granulation, roller compaction, film coating, spray drying, tableting, capsule filling, bottle filling, and blister packing.
- The facility has been designed to accommodate the addition of nano-milling and hot melt extrusion capabilities by next year.
- The facility has been inspected and approved by Indian regulators, the Central Drugs Standard Control Organization (CDSCO) and the Drug Control Administration (DCA).
- The facility can accommodate flexible batch sizes ranging from 1,000 doses to 100,000 doses for solid orals and from 1 litre to 100 litres for liquids and will have a team of about 60 staff operating the facility
The company also informed that this expansion enhances Aragen’s New Chemical Entity (NCE) early-stage development offerings and provides greater flexibility to meet customers’ clinical supply needs in various dosage forms. Aragen can now support its customers’ clinical programs from drug discovery to Phase I-III clinical supply of tablets, capsules, liquids, semisolids, and films to patients in the clinic.