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

Leiner’s U.S. OTC Operations Face Regulatory, Competitive Obstacles

This article was originally published in The Tan Sheet

Executive Summary

Leiner Health Products says the process of restarting its U.S. OTC operations is complicated by Dr. Reddy's Laboratories' termination of contracts to supply ingredients it needs to manufacture OTCs

You may also be interested in...



Leiner’s Return To U.S. OTC Market Complicated By FDA Warning, DOJ Inquiry

FDA's investigation into manufacturing and quality control issues at Leiner Health Products' South Carolina facility revealed a culture of mismanagement that created a pattern of undetected production errors and overlooked discrepancies regarding product development, according to the agency

Leiner’s Return To U.S. OTC Market Complicated By FDA Warning, DOJ Inquiry

FDA's investigation into manufacturing and quality control issues at Leiner Health Products' South Carolina facility revealed a culture of mismanagement that created a pattern of undetected production errors and overlooked discrepancies regarding product development, according to the agency

Leiner’s Return To U.S. OTC Market Complicated By FDA Warning, DOJ Inquiry

FDA's investigation into manufacturing and quality control issues at Leiner Health Products' South Carolina facility revealed a culture of mismanagement that created a pattern of undetected production errors and overlooked discrepancies regarding product development, according to the agency

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS100620

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