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Zydus Pharmaceuticals USA Inc.

210 Carnegie Center, Suite 103

Princeton, N.J. 08540

Key contacts:

KAREN STRELAU, Vice President of Sales

MIKE KEENLEY, Vice President of Marketing and Sales Operations

Phone: (609) 275-5125

Fax: (609) 275-0499

PRINCETON, N.J. -- Zydus Pharmaceuticals USA Inc., a globally integrated pharmaceuticals company, is committed to providing outstanding customer service along with high-quality, affordable products.

With the strength of its leadership (including more than four decades of experience in the United States and the large global presence of its parent Zydus Cadila, the fifth-largest pharmaceuticals company in India) Zydus Pharmaceuticals is well-positioned to meet the needs of today's genetic pharmaceuticals marketplace.

Based on a manufacturing and development history that spans more than 50 years, Zydus Pharmaceuticals' expertise and knowledge afford it the ability to have one of the most comprehensive drug master file (DMF) and abbreviated new drug application (ANDA) pipelines in the industry, comments vice president of sales Karen Strelau.

She says the company has the largest state-of-the-art Food and Drug Administration-approved formulation plant in India and that it is compliant with Good Manufacturing Practices while boasting a capacity of over 8 billion units.

Zydus Pharmaceuticals is also one of India's largest active pharmaceutical ingredient (API) manufacturers with two of its facilities FDA-approved and supporting many of its generic formulations.

Some of the company's other advantages include release technologies, a wide array of dosage forms and innovative product packaging options for its customers, states Strelau.

"Understanding that our customers need a reliable source for safe, effective generic pharmaceuticals, we've put together a 135-member research and development team dedicated to the U.S. market, and it has identified more than 160 products that currently are being worked on," explains Strelau.

To date the company has filed a total of 51 DMFs, received 27 ANDA final and tentative approvals and has 34 ANDAs pending approval with the FDA.

With the recent approvals of amlodipine besylate (bioequivalent to Pfizer Inc.'s Norvasc) and carvedilol (bioequivalent to GlaxoSmithKline PLC's Coreg) Zydus Pharmaceuticals now has more than 150 SKUs commercially available.

Since its first commercial shipment in August 2005 the company has attained unprecedented market share.

"We're extremely proud that for the second straight year Zydus was recognized by IMS Health as one of the fastest-growing pharmaceutical companies in total prescriptions dispensed," declares Strelau.

"We attribute much of this success to our unique customer focus model and our expanding generics portfolio and vertical-integration pipeline," she adds.

Recent approvals include paroxetine tablets, bioequivalent to GSK's Paxil; benzonatate (100- and 200-mg) capsules, bioequivalent to Forest Laboratories Inc.'s Tessalon; and azathioprine tablets, bioequivalent to Prometheus Inc.'s Imuran. Collectively, these regulatory clearances have positioned the company toward additional growth.

The company plans to launch a dozen product families within the next 12 months while filing an additional 24 ANDAs and 15 DMFs.
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Title Annotation:RX/GENERIC DRUGS--Profiles
Publication:Chain Drug Review
Article Type:Company overview
Date:Sep 17, 2007
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