Scrip 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
UsernamePublicRestriction

U.S. FDA Still Allows Ranbaxy Drugs To Be Imported Under Cloud

This article was originally published in PharmAsia News

Executive Summary

Even as the U.S. FDA gathers evidence against India's Ranbaxy Laboratories for allegedly adulterated drugs, the drug maker's products continue to flow into the United States. Already this year, Ranbaxy won marketing rights from the FDA for 11 more drugs. Critics of the FDA and the U.S. Customs Service complain the government is doing little to stop Ranbaxy products from entering the United States, a normal response when an importer is accused of bringing in adulterated and misbranded drugs. (Click here for more

You may also be interested in...



Finance Watch: A SPACtacular Week For Biopharma Deals And Dollars

Public Company Edition: Four health care special purpose acquisition vehicles went public and two others announced mergers, but only one biopharma firm priced an IPO during the week of 19-23 October. Replimune’s $250m offering led recent FOPOs.

US FDA Gives Wholesalers But Not Manufacturers More Time To Begin Verifying Saleable Returns

Wholesalers are given three more years to set up electronic systems to verify saleable returns under another reprieve from the FDA. Yet the reprieve does not extend to manufacturers, who must respond within 24 hours to wholesalers’ requests to manually verify that a returned product is not suspect.

For Emergency Use, US FDA May Visit Rather Than Inspect COVID-19 Vaccine Manufacturing Sites

Agency explains how it will model vaccine authorization process on its licensing process for matters like inspections and lot release.

UsernamePublicRestriction

Register

LL1122620

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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