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

Will Continuous Manufacturing Mean Continuous Generic Delay? FDA Hears AAM's Warning

Executive Summary

Association for Accessible Medicines calls for US FDA to guard against use of continuous manufacturing methods to protect brand drugs from batch-manufactured generic drugs that may be of lower but still acceptable quality. Then FDA approves first generic of a continuously manufactured drug.

You may also be interested in...



Reshoring Debate Continues As COVID-19 Drives New Wave Of US Drug Shortages

As the response to another wave of COVID-19 infections continues, fill rates of critical medicines such as methylprednisolone are dropping. But experts say the answer is not to concentrate manufacturing in US facilities, which could lead to further risks if US supply is disrupted.

Continuous Manufacturing Guidance From US FDA Aims For Wider Industry Adoption

Draft tracks ICH document, which touts the ‘efficiency, agility, and flexibility’ of continuous manufacturing while acknowledging the challenges around the developing practice, ‘particularly for products intended for commercialization internationally.’

FDA Seeks Feedback On Continuous Manufacturing

A draft ICH guidance on continuous manufacturing has been opened up for comment by the FDA, as continuous manufacturing becomes an increasingly prominent topic for the generics industry.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS122069

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