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

UsernamePublicRestriction

FDA Slams Hetero For Oversized Tablets And Dirty Equipment

Executive Summary

In a recent FDA warning letter to Hetero Labs in Hyderabad, India, investigators chastise the firm for lax GMP practices. Hetero joins a growing number of manufacturers in the city that have been targeted by FDA and EU regulators for GMP violations this year.

You may also be interested in...



Industry Worries FDA Will See Drug GMP Violations Captured By Security Cameras

A review of recent US FDA citations has industry concerned about the extent to which agency investigators may be reviewing security video archives as part of their pharmaceutical manufacturing plant inspections.

Dr Reddy’s Faces US Class Action Case Heat

Pressure builds on Dr Reddy’s Laboratories after at least two US law firms press ahead with a class action case against the company. Analysts appear unperturbed, however – at least for now – about the possibility of any material implications.

Dr. Reddy’s Under Fire From German Regulator; Has Risk Of Class Action Suit

Dr. Reddy’s compliance woes hit a new low, with the German regulator stopping supplies to the EU from the firm’s Bachupally unit over significant GMP deviations. Worse still, some foreign investor rights law firms appear to be pressing for a class action suit against the company.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS121442

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