Leading Chinese hepatitis B vaccine makers stop production; Pfizer drug import halted

3 January 2014

China’s Food and Drug Administration announced on January 2 that the country’s three leading manufacturers of hepatitis B vaccine in China have suspended production, reports the state news agency Xinhua.

BioKangtai, Tiantan Biological Products and Dalian Hissen Bio-Pharm failed to meet the 2010 Good Manufacturing Practice (GMP) code for all pharmaceutical manufacturers by the deadline at the end of 2013. Those who did not reach the new standards must suspend production in 2014. The statement by the CDFA says that companies may resume production after certification.

Over the first 11 months last year, hepatitis B vaccines produced by the three suppliers accounted for about 80% of total output. Hepatitis B vaccines sold in China are produced by seven companies, including the UK’s GlaxoSmithKline. Only two have passed the new GMP certification, responsible for no more than 10% of sales.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK