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

BIOPHARMACEUTICS EXPECTS TO RESUME "PARTIAL" MANUFACTURING IN MARCH

Executive Summary

BIOPHARMACEUTICS EXPECTS TO RESUME "PARTIAL" MANUFACTURING IN MARCH, the Bellport, N.Y.-based generic drug firm said Jan. 13. Biopharmaceutics' operations have been suspended since Nov. 1 when FDA was granted a temporary restraining order against the company for problems with good manufacturing practices ("The Pink Sheet" Nov. 11, T&G-6). FDA "examined the company's premises on Jan. 3 and Jan. 6, 1992 and issued their approval letter on Jan. 10," Biopharmaceutics said in a release. "Biopharm believes it will still take approximately two months before it can recommence partial manufacturing operations and three to four months before it can be back in full manufacturing operations." Biopharm noted that it had entered into an amended consent decree with FDA on Dec. 23. Under an earlier consent decree, the company agreed that the firm's own independent consultant will verify that the company is in full compliance with GMPs ("The Pink Sheet" Nov. 25, p. 7). The company also agreed to provide FDA with a protocol for validating its blending methods and to let the agency inspect facilities to confirm compliance before resuming operations. Biopharmaceutics has maintained that the temporary restraining order was "a direct result" of activities by three former employees, who, while working at the firm, ran a business as an intermediate manufacturer for Biopharmaceutics' raw material supplier. A recent FD-483, issued following a May-June inspection, lists 27 observations, including a notation that finished products "are not representatively sampled at the completion of finishing operations." In the Jan. 13 release, Biopharm noted that "although the company has lost some customers, the majority of its sales and customers remain on line and the company expects to both add new customers and to reacquire some or all of the lost customers during the next six months."

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

Latest Headlines
See All
UsernamePublicRestriction

Register

PS020276

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