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The contract manufacturing organization’s facility in Boulder, CO, has passed general inspection from FDA.
On April 4, 2018, CordenPharma, a contract manufacturing organization, announced that its manufacturing facility in Boulder, CO, passed a general FDA inspection in March 2018.
The company reports that all quality systems were evaluated in the inspection, and that the facility received a successful response with no FDA 483 observations reported.
“We are pleased with the outcome of the FDA Inspection in March 2018, as it reflects our willingness to comply with the highest level of cGMP regulatory compliance and represents an important milestone for our CordenPharma Boulder facility, following its acquisition from Pfizer in November of 2017,” said Brian McCudden, managing director of CordenPharma Boulder and previous CEO of CordenPharma Colorado, in a company press release.
In October 2017, CordenPharma announced that it entered into definite agreements to acquire the former Hospira Boulder high-containment API site from Pfizer. Pfizer had acquired the site as part of its $17-billion acquisition of Hospira in September 2015.
Located in the proximity of the existing CordenPharma Colorado facility, Hospira Boulder produces APIs and intermediate products with specialized capabilities in small- to medium-scale highly potent and cytotoxic API manufacturing. The 54,000-ft2 facility with more than 100 employees has API production capabilities ranging from small scale up to 3000 L.
CordenPharma also entered into a multi-year supply arrangement with Pfizer with the expectation that the agreement will help defray costs associated with running the site for the next few years while it adds new client work into the facility, according to CordenPharma.
McCudden was also responsible for Hospira Boulder during one of his previous assignments as an employee of the company. In February 2018, CordenPharma announced that Dr. Riku Rautsola was appointed CordenPharma’s new CEO.