The Global Sourcing Partner of Choice-Zydus Cadila Healthcare & Zydus Pharmaceuticals (USA) Inc.

Generic SupplementsAugust 2009
Volume 0

Zydus Pharmaceuticals (USA) Inc. is the US generic drug division of a much larger, India-based company known as Zydus Cadila Healthcare.

Zydus Cadila is a global, fully integrated pharmaceutical company with a presence in 50 countries and is committed to growing its presence around the world and in the United States.

Zydus Cadila has been achieving this goal through both acquisitions and organic growth. Over the last 4 years, it has acquired companies in France, Japan, Brazil, and, most recently, in Spain and South Africa. Throughout the world, Zydus is focused on providing outstanding customer service, along with high-quality, affordable products. Its vision is to be a leading global health care provider by 2010.

While Zydus Cadila continues to focus on the domestic market in India, it is growing rapidly in key regulated global generic markets, such as the United States, Europe, and Latin America. As the fifth largest pharmaceutical company in India, Zydus is well positioned to meet the needs of today’s generic pharmaceutical marketplace and is forging relationships as a strategic contract manufacturer. What sets the company apart is a never-ending commitment to innovation and building a strong product pipeline, with a focus on products that will deliver the most value to the company as well as customers.

Zydus Cadila takes pride in its manufacturing and development history, which spans more than 50 years. Its FDAapproved Moraiya plant is India’s largest finished dosage plant under one roof, with a total space of 40 acres. Its modular design allows for rapid expansion to add capacity and meet the ever-growing global demand for generic pharmaceutical products. The breadth of the company’s product form capability—tablets, hard and soft gelatin capsules, parenterals, metered dose inhalers, and transdermal patches—sets it up to be “The Global Sourcing Partner of Choice” in the generic pharmaceutical industry.

Three technology centers—the Zydus Research Center, the Pharmaceutical Technology Center, and Active Pharmaceutical Ingredient (API) Process Research—all work together to develop the best quality products now and for the future. Zydus is also one of India’s largest API manufacturers, with 2 of its facilities FDA-approved and supporting many of its generic formulations.

The chief executive officer of the US division, Joe Renner, envisions a US generic marketplace where manufacturers and customers come together in the sourcing of generic products earlier on in the continuum of product management, in order to maximize the risk—reward profiles and deliver maximum value to all parties involved. With major support from its parent company, Zydus Pharmaceuticals (USA) Inc. continues to grow by delivering products to the US marketplace. To date, the company has filed 76 drug master files (DMFs), has received 48 abbreviated new drug application (ANDA) final and tentative approvals, and has 37 ANDAs pending approval with the FDA.

Zydus has had 10 successful “Day One” patent expiration launches: ribavirin tablets, meloxicam, carvedilol, venlafaxine tablets, risperidone IR tablets, benzonatate, mycophenolate capsules and tablets, divalproex sprinkle capsules, lamotrigine CD and IR, and topiramate tablets; it also has more than 149 products commercially available.

Zydus’ success to date is predicated upon its outstanding customer service, expanding generic portfolio, and dedication to being vertically integrated on many finished dosage forms. Its very strong US management team has more than 40 years of experience in the US generic marketplace.

Recent approvals include mycophenolate tablets and capsules, bioequivalent to Roche’s Cellcept®; acetazolamide, bioequivalent to Teva (formerly Barr’s) Diamox®; lamotrigine and lamotrigine CD, bioequivalent to GSK’s Lamictal® and Lamictal CD®, respectively; risperidone, bioequivalent to Johnson & Johnson’s Risperdal®; divalproex sprinkle capsules, bioequivalent to Abbott’s Depakote®; and topiramate tablets, bioequivalent to Johnson & Johnson’s Topamax®.

Zydus is poised to continue its tremendous growth, with its low-cost production, Research & Development/legal/ regulatory capabilities for product development, and, most importantly, customer focus. Clearly, Zydus Cadila and its worldwide divisions are setting themselves up to be known as “The Global Sourcing Partner of Choice.”

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