Merck & Co. Gets FDA Nod to Manufacture Bulk Vaccine at North Carolina Facility - - BioPharm International

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Merck & Co. Gets FDA Nod to Manufacture Bulk Vaccine at North Carolina Facility


Merck & Co. has received FDA approval to manufacture bulk varicella, used in in Merck’s vaccines to protect against chickenpox and shingles, at the company’s site in Durham, North Carolina. The approval will enable the site to produce bulk varicella supply for the United States  and help boost Merck’s overall global supply capabilities.

In 2010, the site was approved to produce finished chickenpox vaccines. In the longer term, Merck plans for the site to produce bulk and finished product for other Merck childhood vaccines and for its shingles vaccines, according to a Sept. 4, 2013 Merck press release.

Prior to this licensure, all global bulk supplies for Merck’s varicella-containing vaccines were produced at the company’s facility in West Point, Pennsylvania. The Durham facility is part of Merck’s more than $1-billion investment in its vaccine-manufacturing capabilities during the past nine years. The company also modernized and expanded vaccine operations at its facilities in West Point, Pennsylvania and Elkton, Virginia and built a new facility in Carlow, Ireland, which is scheduled to be licensed in 2014. Merck broke ground for the Durham site in 2004.

Source: Merck & Co.

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