Generics Bulletin is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Mylan gets warning for Morgantown site

Executive Summary

Mylan has suffered a further manufacturing setback at its flagship facility in Morgantown, US, after the US Food and Drug Administration (FDA) issued the site with a warning letter concerning its finished-dosage forms. Following an inspection at the plant from 19 March to 12 April, the agency identified “significant violations” of current good manufacturing practice (cGMP) and said it may withhold new approvals linked with the site.

You may also be interested in...



Viatris Still Exploring Alternatives For Morgantown Plant As Closure Looms

The end of July will bring the closure of Viatris’ Morgantown plant, following years of compliance issues for the once flagship Mylan facility. But the company has revealed that it is still in the process of exploring alternatives for the site outside of Viatris.

Mylan Delays Restructuring Amid COVID-19

Mylan has delayed a major restructuring program ahead of its planned merger with Pfizer’s Upjohn unit due to the impact of the COVID-19 pandemic, which at the same time brought tailwinds for the firm’s first-quarter results.

Mylan’s ‘Durable’ Model Has Helped Weather Storms

Mylan says its ‘durable’ business model has helped it to withstand pressures from adverse industry trends in 2019, boosted by $1bn in sales from newly-launched products. However, negative currency effects cut the firm’s sales growth from 3% at constant currencies to 1% as reported.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

GB001508

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel