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


Actavis resumes manufacturing of oxycodone

This article was originally published in The Gold Sheet

Executive Summary

Actavis Totowa said FDA gave it approval to resume production of painkiller oxycodone 15 mg and 30 mg tablets at its Little Falls, N.J., facility following an agency inspection. The reopening will help ease a shortage of oxycodone that followed various FDA enforcement actions, including one that led Actavis last August to recall oxycodone and 65 other products made at its Little Falls plant, which shut down after FDA found numerous GMP violations. A Dec. 29 FDA consent decree set conditions for resuming production at Little Falls and two Totowa, N.J., facilities. "Through an extensive process, Actavis re-qualified all equipment and utilities for production and packaging - and we re-qualified and revalidated all methods used to release products from our Totowa facilities," said Nasrat Hakim, vice president of quality compliance and technical services for Actavis

You may also be interested in...

US FDA And NIST Form Partnership To Boost Advanced Manufacturing Techniques

The US FDA and NIST have agreed to help industry modernize and update pharmaceutical manufacturing methods and to improve supply chain resilience.

Medtronic Looks To Adaptive DBS To Advance Treatment Of Parkinson’s Disease

Medtronic is sponsoring a trial to evaluate its adaptive deep brain stimulation technology, a unique feature of the Percept PC device for treating Parkinson’s disease.

Merck & Co. Pivots To COVID-19 Treatments After Vaccines Disappoint

The company cited lackluster efficacy in its decision to discontinue development of V590 and V591. It will instead develop two drugs to treat COVID-19.




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