Aragen, a leading provider of contract research, development, and manufacturing services for the pharmaceutical, biotechnology, agrochemicals, and animal health sectors, has inaugurated its advanced formulations manufacturing facility in Hyderabad, India. This cutting-edge facility, established at a cost of USD 3 million, is situated at the Mallapur Campus in Hyderabad, covering an expansive area of 12,000 square feet. It is equipped to facilitate the clinical production of a diverse range of dosage forms, including oral solids, liquids, topicals, and films. Aragen's substantial investment in this facility underscores its unwavering commitment to advancing pharmaceutical research and development, complementing its already well-established pre-formulation capabilities.
Manni Kantipudi, CEO of Aragen Life Sciences, expressed enthusiasm, stating, "We are delighted to announce the commissioning of our new formulations manufacturing facility in Hyderabad. This state-of-the-art facility signifies a significant milestone in Aragen's journey, reaffirming our dedication to innovation and excellence. With this expansion, we can provide our clients with an even wider array of services, spanning from early-stage development to clinical manufacturing, all from a seamlessly integrated facility. We eagerly anticipate leveraging these capabilities to support our clients' drug development endeavors, enabling them to bring transformative medicines to patients globally."
Noteworthy features of the facility include:
- Versatile Formulation Technologies: The facility is outfitted with a comprehensive array of formulation technologies, encompassing wet granulation, roller compaction, film coating, spray drying, tableting, capsule filling, bottle filling, and blister packing.
- Future-Ready Design: The facility has been purposefully designed to accommodate the incorporation of nano-milling and hot melt extrusion capabilities in the coming year, ensuring that Aragen remains at the forefront of pharmaceutical innovation.
- Regulatory Approvals: The facility has undergone rigorous inspections and received approvals from Indian regulators, including the Central Drugs Standard Control Organization (CDSCO) and the Drug Control Administration (DCA). It has also successfully cleared multiple client audits, underscoring its steadfast commitment to upholding the highest standards of quality and compliance.
- Capacity: The facility boasts the capability to handle flexible batch sizes, ranging from 1,000 doses to 100,000 doses for solid orals, and from 1 litre to 100 litres for liquids. It will be staffed by a team of approximately 60 professionals.
This expansion significantly enriches Aragen's offerings in New Chemical Entity (NCE) early-stage development and provides heightened flexibility to meet the clinical supply requirements of customers across various dosage forms. Aragen is now poised to support its clients' clinical programs as an integrated end-to-end service provider, covering drug discovery through Phase I-III clinical supply of tablets, capsules, liquids, semisolids, and films for administration in clinical settings.
Since 2018, Aragen has been providing Formulation R&D services from its 10,000 square foot research facility. The establishment of the Formulation manufacturing facility represents a forward integration strategy, further reinforcing its position as a comprehensive 'one-stop solution provider' for the life sciences industry.
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