Zydus Pharmaceuticals USA, Inc.

Generic SupplementsGeneric Supplement 2017

Zydus Pharmaceuticals (USA) Inc,. located in Pennington, New Jersey, has come a long way since its first commercial launch in August 2005.

Zydus Pharmaceuticals (USA) Inc,. located in Pennington, New Jersey, has come a long way since its first commercial launch in August 2005. The company currently offers more than 270 SKUs to the US market and is ranked the ninth largest unbranded generic corporation in the US based on dispensed prescriptions, (IMS Health, NPA Audit, MAT April 2017). Since Zydus first entered the US market, it has purchased two facilities in the US - Nesher Pharmaceuticals in St. Louis, Missouri and Hercon Pharmaceuticals in York, PA. These acquisitions have helped Zydus to grow from a generic company focused on solid oral generics to a company that offers more complex dosage forms such as oral suspensions, modified release oral solids, transdermals, controlled substances, and injectables.


Zydus has had an exciting first half of 2017. In the first six months of the year, Zydus received final approval on 24 Abbreviated New Drug Applications (ANDAs), one of which being the first AB-rated generic to Lialda® (mesalamine 1.2gm delayed-release tablets). Zydus launched its mesalamine 1.2gm dealyed-release tablets in July. Over the course of the year, Zydus has also launched several other products such as acamprosate delayed-release tablets, methotrexate tablets, olmesartan tablets, and, oseltamivir capsules. As Zydus enters the second half of the year, it plans to bring many more costsaving generics to market to help improve patients’ lives. Zydus was also honored to receive the 2017 HDA Diana Award for Manufacturer Partner of the Year with Sales Less than $500 Million.


Zydus Pharmaceuticals’ parent, Zydus Cadila, an innovative global pharmaceutical company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. Zydus Cadila is India’s 4th largest pharmaceutical company and has experienced tremendous growth over the past several years. The company has business operations in more than 50 countries, including the United States, France, Spain, Brazil, Mexico, and South Africa. With over 20,000 employees across 26 countries, 1,200 highly accredited scientists; 11 USFDA inspected sites supporting finished product and API manufacturing, and the ability to manufacture a wide variety of dosage forms. Zydus Cadila is dedicated to creating healthier communities globally and aspires to be a researchbased pharmaceutical company by 2020.


While Zydus has grown tremendously over the past 12 years, the company is continuing to look for new ways to bring value to the US market. Zydus is aggressively pursuing franchises it does not exist in today to further its footprint in the lives of patients. The company recently launched its first product out of its oncology facility and is planning on launching its first dermatological product later this year.

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 127 drug master files (DMFs), received final USFDA approval on 119 Abbreviated New Drug Applications (ANDAs), received tentative USFDA approval on 8 ANDAs, and has more over 200 ANDAs pending approval with the USFDA. The company also has approximately 300 additional products in various stages of development. Look for some exciting announcements from Zydus over the next 12 months, as they are truly “poised for the future.”

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