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

US FDA Warns Torrent Over Losartan Process Validation, OOS Invalidation Failures

Executive Summary

Warning letter stemming from global nitrosamine investigation raises new concerns about Indian manufacturer.

You may also be interested in...



More Change With Less Hoopla To FDA Out-Of-Specification Investigations Policy

Agency’s revised OOS guidance clarifies positions on outlier test results, averaging of HPLC results and some finer points around OOS questions. These could marginally improve compliance but won’t impact industry with nearly the force of the original 2006 guidance or the 1993 court ruling that preceded it.

Torrent Sees Decline In US Sales After Dropping Sartan Portfolio

Torrent Pharma has reported a double-digit drop in its US revenues after discontinuing its sartan portfolio, due to the presence of trace amounts of N-nitrosodimethylamine. The company saw its domestic market grow aided by market share gains in high potential new launches.

Regulatory Overhang Hurts Torrent

Torrent has tempered US growth expectations while it plans to put its Dahej, Indrad and Levittown plants up for FDA inspection in 2020. Meanwhile, products launched in India, including remoglifozin in-licensed from Glenmark, have shown an encouraging uptake.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS141033

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