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 BEGINS SHIPMENT OF FIVE OTC PRODUCTS NOV. 22

This article was originally published in The Tan Sheet

Executive Summary

BIOPHARMACEUTICS BEGINS SHIPMENT OF FIVE OTC PRODUCTS NOV. 22 after an FDA inspection on Nov. 19 found the company's Bellport, N.Y. facility to be in compliance with current good manufacturing practices. The five products are: 80 mg chewable acetaminophen tablets in fruit and grape flavor, 500 mg acetaminophen tablets and caplets and 50 mg dimenhydrinate tablets. FDA approved the process validation for the five items in October but said it needed to verify by inspection that the products were in compliance with GMPs ("The Tan Sheet" Oct. 11, In Brief). The Nov. 19 inspection also paves the way for Biopharmaceutics to begin shipping other OTC as well as prescription drugs. Biopharmaceutics expects to submit 15 additional OTC and prescription products to FDA for clearance in 1994. The 20 products constituted 90% of Biopharmaceutics' sales volume of manufactured goods before FDA obtained a temporary restraining order in November 1991 that prohibited the firm from manufacturing any generics because of GMP violations at the facility. The temporary restraining order was followed by a consent decree in late November 1991 under which Biopharmaceutics was required to have an independent consultant verify GMP compliance at the Bellport facility. In July, Biopharmaceutics agreed to pay $ 350,000 to settle a Justice Department investigation into submission of false R&D information on ANDAs for Rx clindamycin 150 mg capsules, carisoprodol with aspirin and chlorzoxazone 500 mg tablets. Former company VP Abu Quamruzzaman was sentenced Oct. 14 to nine months in prison after pleading guilty in July to submitting the false ANDA information for clindamycin 150 mg capsules.

You may also be interested in...



Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC

In Brief

Combe sells most of its OTC brands

People In Brief

Perrigo promotes in pricing, planning

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS082186

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