Zydus Pharmaceuticals: The Quality You Expect, the Service You Deserve, the Innovation You Want

Zydus Pharmaceuticals (USA) Inc., located in Pennington, New Jersey, is looking forward to its future in the US pharmaceutical market. Since its first commercial launch in August 2005, it has grown steadily over the past 10 years and now offers more than 315 SKUs to the US market. Some of Zydus’ recent launches include potassium chloride extended-release tablets 8 mEq, etomidate injection, morphine sulfate extended-release tablets, and isosorbide mononitrate extended-release tablets. Zydus will also be launching pyridostigmine bromide tablets in August 2015. Zydus is currently ranked the eighth largest unbranded generic corporation in the US market based on dispensed prescriptions (IMS Health).

This is an exciting time for Zydus, as the company continues to expand its portfolio to offer new dosage forms and enter different franchises within the US pharmaceutical market. With the purchase of Nesher Pharmaceuticals in St. Louis, Missouri, Zydus has a footprint in the US that has allowed Zydus to enter the controlled substances sector. Zydus recently expanded its controlled substance portfolio with the launch of morphine sulfate extended-release tablets. Zydus is also aggressively pursuing other franchises, such as dermatologic and transdermal products, as well as oncology products. The company has worked extremely hard to put together a rich product pipeline for the future.

Zydus Pharmaceuticals’ parent company, Zydus Cadila, is India’s fourth largest pharmaceutical company and has experienced tremendous growth over the past several years. It is a global pharmaceutical company with business operations in more than 50 countries, including the United States, France, Spain, Brazil, Mexico, and South Africa. This past year, Zydus Cadila launched Exemptia, the world’s first biosimilar of adalimumab. Zydus Cadila is also the only Indian pharmaceutical company to launch its own patented new chemical entity, Lipaglyn, which is the world’s first drug to be approved for the treatment of diabetic dyslipidemia. With over 16,500 employees across 26 countries, India’s largest finished dosage plant under one roof, 2 FDA-approved API sites, and the ability to manufacture a wide variety of dosage forms, Zydus Cadila is more than ready to support the rapidly growing US pharmaceutical market. The recent FDA approval of Zydus’ Baddi plant and completion of its newest manufacturing facility, Zydus will soon have a pill and capsule capacity exceeding 20 billion annually.

With the strength and worldwide reputation of Zydus Cadila supporting the US division, Zydus is looking forward to continuing its growth in the US marketplace. As the company focuses its efforts on more challenging and rewarding opportunities, including several first-to-file and 505(b)(2) opportunities, it looks forward to great success in the coming years. To date, Zydus has filed 111 drug master files (DMFs), received final FDA approval on 80 Abbreviated New Drug Applications (ANDAs), has tentative approval on 8 ANDAs, and has over 150 ANDAs pending approval with the FDA. Look for some exciting announcements from Zydus over the next 12 months, as they are truly “poised for the future.”

For more information, visit www.zydususa.com.