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Investment at Capsugel’s Edinburgh, Scotland facility will expand the company’s liquid- and semi-solid-fill capsule manufacturing capacity.
Capsugel announced on July 22 an expansion that will more than double the size of its Edinburgh, Scotland facility by adding 40,000 sq ft of space. The expansion will enable the Dosage Form Solutions business unit to both increase its liquid- and semi-solid-fill hard capsule manufacturing capacity for drug products containing high-potency APIs (HPAPI) and further diversify its technology platforms offered at the facility, according to a Capsugel statement.
The first phase of the expansion includes analytical, formulation, and quality laboratories for bioavailability, HPAPI, and other formulation challenges. The second phase, which is scheduled to begin later in 2015, will expand commercial manufacturing capacity and bring the company’s other formulation and development technologies, including spray dried dispersion (SDD), to this location.
Over the past two years, the Edinburgh facility, which Capsugel acquired as part of its purchase of Encap Drug Delivery in March 2013, has experienced a 40% growth in its development services business, and established a commercial manufacturing pipeline, including eight late-stage projects in process.
The Edinburgh facility had successful inspections by the Medicines and Healthcare Products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA) in 2014. That same year, the site secured two customer project approvals with the MHRA. Earlier this year, the site collaborated with a customer to file a new drug application (NDA) registration with the FDA, and it is expecting multiple new product filings per year for the foreseeable future.