news release

HUECK FOILS OFFERS “HOW TO” GUIDE FOR MEETING FDA INTERCHANGEABILITY GUIDELINES
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New Process Takes Only Two Weeks and Saves Thousands of Dollars

WALL, NJ -- According to an October, 1999 FDA ruling, it is now permissible for pharmaceutical manufacturers to switch suppliers of primary packaging materials without the need for full stability protocol testing, provided that equivalency can be proven that meets FDA requirements on interchangeability of packaging materials.

Entitled Changes to an Approved NDA or ANDA , the FDA-issued guidelines (21 CFR 314.70 (d) (6) ) do require that the materials a company is switching to are:
1) already approved for drug product contact by the FDA;
2) have a current DMF on file with the FDA;
3) have been reviewed elsewhere for other similar dosage forms by the FDA; and
4) they provide a barrier that is as good as if not better than the current material upon which the stability test was conducted.

“If these criteria are met, the change is considered “Minor” and a pharmaceutical company can switch from their current supplier to HUECK FOILS without conducting full stability testing protocols,” explains Paul Mangano, Healthcare Market Manager for HUECK FOILS L.L.C.

“Typically, stability testing is a lengthy process costing companies in excess of $25,000. Now, under the recent FDA guidelines, the process for materials change can be accomplished in as little as two weeks and at a significantly reduced cost,” he said. “In order to help companies take advantage of the new guidelines from a regulatory perspective, we have prepared an easy-to-follow, step-by-step package that walks a prospective new customer through the process.”

The “How To” package provides a guide on documentation necessary for an annual submission to an ANDA/NDA. It also outlines the requirements for the application holder and details the supporting documentation that HUECK FOILS will provide to customers interested in switching to Hueck materials.
For pharmaceutical manufacturers interested in more information on how to receive this package, contact Paul Mangano by telephone at (804) 346-3966; or e-mail at paul.mangano@hueckfoils.com.

HUECK FOILS L.L.C., a leading converter of foils and films for the healthcare and food industries, is located at 1955 Highway 34, Building Two, Wall, New Jersey 07719; telephone (732) 974-4100; fax (732) 974-4111. It is a subsidiary of Hueck Folien GmbH & Co. KG, Germany, one of the world’s largest independent foil and film converters. With facilities in Columbia, South Carolina; Weiden, Germany; Baumgartenberg, Austria; Weinstadt, Germany; and Louvain-La-Neuve, Belgium, Hueck holds ISO 9001/EN 29001 certification for professional competence and customer-oriented emphasis on quality.

HUECK FOILS is a member of both the Healthcare Compliance Packaging Council (HCPC) and the Flexible Packaging Association.

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