Merck Opens New Manufacturing Facility in China
April 18th, 2013 // 3:27 pm @ jmpickett
Updated Daily – Read our latest FDA, cGMP Compliance News
Merck, known as MSD outside of the United States and Canada, opened a facility in Hangzhou, China to package Merck medicines for China and the Asia Pacific region, announced the company in an April 16, 2013 press release. The facility, a nearly $120-million investment by Merck, is located in the Hangzhou Economic and Technology Area (HEDA).
May 1 – Avoiding Warning Letter Disasters With a Strong cGMP and GCP Quality Agreement
Merck also has an R&D Center in Beijing, three manufacturing facilities throughout the country, a marketing and sales organization headquartered in Shanghai, and employs more than 5000 employees in China. The healthcare system in China is growing rapidly, notes the company. In 2011, Merck established its Asia R&D headquarters in Beijing and committed to invest more than $1.5 billion in R&D in China over the next five years.
The new 75,000-m2 facility is capable of holding up to 16 high-speed lines to package pharmaceutical tablets and sterile Merck medicines that are used to manage diabetes, cardiovascular, infectious, respiratory, and bone diseases. Packaging capacity is currently estimated at more than 300 million packages annually. Products used in Merck’s clinical studies and in its commercial activities to support future new product launches also will be packaged at the new HEDA plant. The HEDA facility received a cGMP certification in January 2013. The facility was constructed with consideration for the environment; special air, waste, and water-management procedures and systems were built into the facility, notes the company.
Upcoming FDA cGMP Expertbriefings.com Webinars for 2013 include:
- April 23 – Spend $500K on Compliance or $300 Million on Consent Decree? – Essential cGMP Compliance Tips for Sr. Management
- April 25 – How to Survive PREDICT – FDA’s New Import Screening Program
- April 29 – Audit Your Lab Like an FDA Auditor – A Roadmap to cGMP Lab Compliance
- April 30 – How to Prepare Yourself for 21 CFR Part 11 Inspections
- May 1 – Avoiding Warning Letter Disasters With a Strong cGMP and GCP Quality Agreement
- May 2 – Avoid the CDRH eCopy Confusion – How to Prepare a Compliant eCopy Submission
- May 7 – FDA Recall Chief Update – How to Design a Bulletproof Recall Strategy
- May 15 – FDA Chief Counsel Report – How to Deal With and Avoid Warning Letters
Updated Daily – Read our latest FDA, cGMP Compliance News
