FDA warns Lijiang Yinghua over repeated manufacturing failures

2 May 2018
drugs_pills_tablets_big

The US Food and Drug Administration has sent an official warning letter to Yinghua Liu, the president of China-based API maker Lijiang Yinghua, related to problems concerning data integrity and quality.

In the letter, the agency states that problems uncovered during a 2015 visit to the firm’s Yunnan-based manufacturing facility had not been resolved at the time of an inspection last October.

The firm manufactures numerous key ingredients used in pharmaceutical products, including testosterone, progesterone and pregnenolone.

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.

Login to your account

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



Today's issue

Company Spotlight





More Features in Generics