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RICHLYN LABS" NEW OWNER GLOBAL PHARMACEUTICAL CORP.

This article was originally published in The Tan Sheet

Executive Summary

RICHLYN LABS" NEW OWNER GLOBAL PHARMACEUTICAL CORP. is working closely with FDA and the company's regulatory consultant, former FDA Philadelphia District Office compliance chief Philip Sheeler, to bring the 45-year-old Philadelphia generic drug maker into full compliance with all current good manufacturing practices regulations. Richlyn is currently not shipping product, but is continuing to carry out R&D activities. Global Pharmaceutical Corp. (GPC) reported Sept. 17 that it acquired Richlyn's assets, which include "over 50" generic prescription and OTC drugs as well as vitamins, inventory, equipment and 112,000 square feet of manufacturing facilities, on Aug. 18. Richlyn Labs was the subject of a May 25 permanent injunction barring the company from shipping into interstate commerce any drug that is misbranded due to false or misleading labeling or that is adulterated due to noncompliance with cGMPs. The company was issued a restraining order on Sept. 21, 1992 and was placed under a preliminary injunction Oct. 1 of last year. The court actions followed a series of Class II and Class III recalls. GPC said its plans for Richlyn include "a major multi-million dollar renovation" of the company's Philadelphia plant. Initial renovations will "consist of upgraded air handling systems and remodeling of all manufacturing laboratory and packaging areas to highest industry standards." Heading up Richlyn's manufacturing and packaging operations as president and chief operating officer is Carmine Mascoli, PhD. Mascoli previously has been with Baxter-Travenol, Squibbmark and Barre-National. He is working with regulatory consultant Sheeler and FDA, as is Richlyn's new quality assurance/quality control head Anthony Donato, who joined the company from Smith Kline & French. Under the product and system revalidation plan devised in conjunction with FDA, Richlyn is focusing first on releasing current inventories of manufactured but not yet recertified products. The company is spotlighting its efforts on two generic OTC and 26 prescription products and said it hopes to ship some product within six months. Within 12 months, Richlyn could be shipping products that represent 50%-70% of sales, GPC forecasted. GPC has hired approximately 15 managers for Richlyn and anticipates having a staff of 70-100 people within 12 months. Sales and marketing functions will be handled by Global Source Management & Consulting, which will bolster Richlyn's former sales and marketing reach. GPC was established in April under the leadership of ex- Goidline Labs owner Gary Dubin as CEO. Richlyn is GPC's first acquisition. The Hollywood, Fla.-based corporation was created to acquire generic drug companies that have a solid ANDA base but have not kept up with FDA's current GMP requirements or with sales and marketing upgrades. Joining Dubin on the board of GPC are former Pennex Labs owner Mort Resak; former Barre-National head Max Mendelsohn; current Richlyn head Mascoli; and one of Richlyn's former owners, Richard Weinberg, who, under a GPC decision, has no GMP responsibilities. Jack Gumbhir, PhD, who heads the University of Kansas pharmacy PhD program, is a consultant. GPC is financing the recertification/revamping of Richlyn with investor money from GPC and Richlyn stockholders, as well as with money from both the Philadelphia Industrial Development Corp. and the Pennsylvania industrial development fund.
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