Scrip 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

After A Brief Pause, Injectables Cash Cow Agila Is Back Into Production; Pfizer Expects Shipping To Commence Soon

This article was originally published in PharmAsia News

Executive Summary

Agila, as its name suggests, was agile in correcting deficiencies outlined in an FDA 483 last month and is back on track to supply global customers like Pfizer, GSK and Eli Lilly. But Mylan’s planned buyout of Agila, Strides Arcolab’s cash cow, has hit a snag and been put on hold by India’s finance ministry.

You may also be interested in...



Mylan’s Autor-de-Force Move into Quality “Differentiation” and Sterile Injectables

Mylan is investing heavily to create a competitive advantage based on manufacturing quality – and public policy. The firm’s recruitment of FDA’s Deborah Autor highlights a strategy to spend more on quality while aiming at higher margins, especially in sterile injectables where the company sees an opening after widespread quality breakdowns across the industry.

Form 483 Reply Can Be Ticket To FDA’s Good Side – Attorney

Taking a conciliatory tone and showing a commitment to compliance can help a company avoid further enforcement action after receiving a form 483 from FDA that details “significant” inspectional observations, says food and drug attorney Kate Beardsley.

Drug Shortages Mostly FDA’s Fault, House Oversight Committee Concludes

Report says aggressive enforcement in recent years has forced capacity offline, which led to shortages.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

SC084824

Ask The Analyst

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

Thank you for submitting your question. We will respond to you within 2 business days. 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