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

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

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.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes

Click here