Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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


GSK Faces 'Profoundly Difficult' Penicillin Challenge, FDA Warning Letter Says

Executive Summary

Aging plant in Worthing, UK, must either dedicate building solely to penicillin or undergo wrenching decontamination before US distribution of non-penicillin products could resume.

You may also be interested in...

Enforcement in Brief

FDA and PIC/S inspection approaches are evolving, with FDA focusing on beta-lactams, CMOs and contract labs; and PIC/S working on inspection sharing, harmonizing on deficiencies, data integrity guidance and inspector training. Meanwhile, Dr Reddy’s gets warning letter, AstraZeneca sees EU noncompliance and four firms added to FDA’s drug GMP import alert.

A Day of Reckoning for Aging Facilities: Is It Time to Invest in Change?

With its acquisition of Hospira, Pfizer joins the ranks of pharmaceutical companies struggling to eke out a profit from aging sterile injectables facilities without shutting them down for badly needed upgrades for fear of triggering additional drug shortages. Meanwhile, flexible, modular next-generation facilities that could add capacity where needed are on the horizon.

EMA consults on tackling cross-contamination at shared drug manufacturing facilities

The European Medicines Agency is inviting feedback on a draft guideline that explains how companies that make different medicinal products at shared manufacturing facilities should review and evaluate pharmacological and toxicological data of individual products to tackle cross-contamination issues1.





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