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


FDA Will Peel Back Another Layer Of GMP Compliance In 2013

This article was originally published in The Tan Sheet

Executive Summary

FDA will take GMP inspections beyond the basics in 2013, experts agree. Firms can expect more inspections, deeper dives from reviewers and tougher consequences.

You may also be interested in...

FDA Will Crack Down On GMP Ingredient, Contaminant Spec Requirements

GMP inspectors will begin more aggressively enforcing requirements for ingredient and contaminant specifications, FDA’s Fabricant warns. Recalls for undeclared allergens, salmonella and other pathogens are emerging more frequently as well.

GMPs Send Smaller Supplement Firms Into Contract Manufacturers’ Arms

FDA enforcement of the good manufacturing practices final rule causes some in the supplement industry to question whether small and medium-sized firms can manufacture in-house successfully. Meanwhile, third-party manufacturers are realizing the benefits of a tighter regulatory environment.

Valeant’s OTC Pickups Emphasize Specialty Segments, Growth Markets

The Montreal pharma company includes a focus on OTCs and generics in its quest to grow while remaining relatively immune to patent cliffs and scaled-back Rx reimbursements. Valeant’s recent PEDiNOL Pharmacal acquisition, including OTC podiatry products, fits into its niche category strategy.

Related Content


Related Companies




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