Aragen has commissioned this state-of-the-art facility, set up at an investment of $3 million, located at the Mallapur Campus in Hyderabad and spans more than 12,000 sqft.
It is equipped to support the clinical manufacturing of a wide range of dosage forms, including oral solids, liquids, topicals and films.
Aragen's investment in this facility is a testament to its dedication to advancing pharmaceutical research and development and is synergistic to its well-established preformulation capabilities.
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
- Manni Kantipudi, CEO, Aragen Life Science
Manni Kantipudi, CEO, Aragen Life Sciences, commented: "We are thrilled to announce the commissioning of our new formulations manufacturing facility in Hyderabad."
"This state-of-the-art facility represents a major milestone in Aragen's journey, reinforcing our commitment to innovation and excellence. 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." Key highlights of the facility include the following.
- Versatile Formulation Technologies: The facility is equipped with a comprehensive suite of formulation technologies, including wet granulation, roller compaction, film coating, spray drying, tableting, capsule filling, bottle filling and blister packing.
- Future-Ready Design: The facility has been strategically designed to accommodate the addition of nano-milling and hot melt extrusion capabilities by next year, ensuring that Aragen stays at the forefront of pharmaceutical innovation.
- Regulatory Approvals: The facility has been inspected and approved by Indian regulators, the Central Drugs Standard Control Organization (CDSCO) and the Drug Control Administration (DCA). It has also successfully undergone multiple client audits, demonstrating its commitment to maintaining the highest standards of quality and compliance.
- Capacity: The facility can accommodate flexible batch sizes ranging from 1000–100,000 doses for solid orals and from 1–100 L for liquids and will have a team of about 60 staff operating the facility.
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 programmes as an integrated end-to-end service provider, from drug discovery to Phase I-III clinical supply of tablets, capsules, liquids, semisolids, and films to patients in the clinic.
