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



Executive Summary

PENNEX SHIPMENTS FROM ILLINOIS PLANT HAVE BEEN HALTED since mid-July as the result of GMP problems, including concerns about the facility's water system. Pennex Pharmaceuticals is currently enjoined from shipping any products from its recently acquired Morton Grove, Ill. facility under a consent order filed July 23 in Chicago federal court. The agreement was filed on behalf of FDA as a mass seizure action which was waived upon the company's agreement to the consent order. Pennex says it hopes to resume shipments from the closed plant "soon." Pennex discontinued shipping products on July 17. Under the terms of the agreement, Pennex is enjoined from shipping any product that has been "manufactured, processed, packed, labeled, stored or held" at the Morton Grove plant "except for manufacturing solely for the purpose of attempting prospective validation of processes" until FDA is satisfied that the facility is in compliance. Pennex will also pay the cost of validation inspections and court costs. Pennex purchased the Morton Grove facility from Pharmaceutical Basics, Inc. March 22 ("The Pink Sheet" March 29, T&G-9). Under the consent agreement, Pennex agreed to retain an independent investigator in order to "determine whether the methods, facilities and controls are operated and administered in conformity with...GMP regulations for drugs." Pennex hired an independent consultant in March when it purchased the facility from PBI. The complaint, U.S. v. Multi-Vita Drops with fluoride... and all other finished dosage form prescription and over-the- counter drugs located on the premises of Pennex Pharmaceuticals, alleges that the articles in question are " that the methods used in, and the facilities and controls used for their manufacture, processing, packing and holding do not conform to and are not operated and administered in conformity with the current good manufacturing practice requirements." Pennex indicated that one issue at the Morton Grove facility involved concerns with the water system. At least two recalls have occurred at the Morton Grove facilities since it changed corporate hands. The company conducted a nationwide recall of 315,771 units of promethazine prescription oral liquid cough and cold preparations due to subpotency. On June 4, Pennex initiated a nationwide recall of 90,371 units of lidocaine oral topical solution due to subpotency. Both recalls involved products that were manufactured before Pennex bought the plant. Pennex President Jack Van Hulst previously served as president of PBI. During his tenure at PBI, he negotiated the purchase of the Morton Grove facility (then My-K Labs) from Kun Chae Bae in 1988. Several employees working under Van Hulst at PBI/Akzo followed him to his new job at Pennex in 1992. On Aug. 12, Pennex announced an agreement to sell its Verona, Pa. OTC manufacturing facility to Rexall Sundown. Pennex Products concurrently filed for Chapter 11 bankruptcy protection for its Verona operations. Pennex Pharmaceuticals plans to continue operations of the Morton Grove plant under a new label.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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