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


That’s The Way The Tablet Crumbles: Industry Protests FDA Friability Test

Executive Summary

A split tablet’s structure is compromised by definition and shouldn’t be subjected to friability testing, drug manufacturers argue in response to an FDA draft guidance.

You may also be interested in...

Can Warner Chilcott Run Up The Scores On Generics?

Success of petition seeking to block single-scored generics of Doryx will likely rest on the brand firm's ability to make a safety and efficacy case for its dual-scored version of the antibiotic, which may be difficult given that it was marketed as a single-scored tablet for so long.

FDA Tablet Scoring Guidance Advises Testing Patient Ability To Split Pills

One of the intriguing elements of FDA’s draft guidance on tablet scoring is how it handles the relationship between brand and generic versions of the products.

Ranbaxy’s Atorvastatin Recall: Will Glass Shards Nick FDA’s Reputation?

Less than a year after signing a consent decree to resolve compliance problems, the company is forced to stop manufacturing its generic version of the best-selling cholesterol drug. For FDA, the issue poses a public relations challenge since it touches on several areas where the agency has recently been criticized – generic drug quality, manufacturing oversight and drug shortages.


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