Pink Sheet 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

Roxane Alupent Production To Be Halted While GMP Concerns Are Addressed

Executive Summary

Roxane Labs is temporarily halting production of its asthma product Alupent following receipt of a July 12 FDA warning letter on GMP deficiencies in the manufacturing of liquid drug products at its Columbus, Ohio facility.

You may also be interested in...



Third Quarter Conference Calls, In Brief

Pfizer Spiriva production: Boehringer-Ingelheim "has sufficient manufacturing capacity already in Germany" to meet demand for the chronic obstructive pulmonary drug Spiriva (tiotropium) "for out as far as we can see," Pfizer CEO Henry McKinnell tells Oct. 17 conference call. Pfizer will copromote the BI agent, with launch expected in 2002 or 2003. BI's Columbus, Ohio facility "was to come on stream for production in 2005," McKinnell noted. The plant was the subject of an FDA warning letter in July (1"The Pink Sheet" July 30, p. 10)...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

Latest Headlines
See All
UsernamePublicRestriction

Register

PS038270

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