Zydus Pharmaceuticals

AUGUST 08, 2018
History of Zydus
Zydus Pharmaceuticals (USA) Inc, of Pennington, New Jersey, has come a long way since its first commercial launch in August 2005. The company offers more than 330 stock keeping units in the US market and is ranked the ninth-largest unbranded generic corporation in the United States based on dispensed prescriptions, according to the IQVIA National Prescription Audit, MAT April 2018. Since Zydus first entered the US market, it has purchased 2 facilities in the United States: Hercon Pharmaceuticals of York, Pennsylvania, and Nesher Pharmaceuticals of St Louis, Missouri. In 2017, Zydus Pharmaceuticals also acquired Sentynl Therapeutics Inc, a specialty pharmaceutical company based in Solana Beach, California. These acquisitions have helped Zydus Pharmaceuticals grow from a generics company focused on solid oral generics to one that offers more complex drug forms, such as controlled substances, injectables, modified-release oral solids, oral suspensions, and transdermals.

2018 at a Glance
After achieving a record 81 FDA approvals in 2017, Zydus Pharmaceuticals has continued the momentum into 2018. In the first half of the year, the company launched 23 product families and received final approval on 15 abbreviated new drug applications (ANDAs). Some of Zydus Pharmaceuticals’ key launches this year include doxycycline hyclate injection, oxybutynin extended-release tablets, ritonavir tablets, and trazodone tablets. Zydus Pharmaceuticals also launched its first 505(b)(2) product, Zypitamag, through a partnership with Medicure. Because of last year’s flu season, Zydus Pharmaceuticals’ Nesher facility has been busy manufacturing its oral suspension and oseltamivir phosphate capsules to ensure a seamless supply for the upcoming flu season. As Zydus Pharmaceuticals enters the second half of 2018, it plans to bring many more cost-saving generics to market to help improve patients’ lives.

Zydus Cadila
Zydus Pharmaceuticals’ parent company, Zydus Cadila, is an innovative global pharmaceutical company that discovers, develops, manufactures, and markets a broad range of health care therapies. Zydus Cadila is India’s fourth-largest pharmaceutical company and has experienced tremendous growth over the past several years. The company has business opera­tions in more than 50 countries, including Brazil, France, Mexico, South Africa, Spain, and the United States. With more than 20,000 employees across 26 countries, 1350 highly accredited scientists, and 11 FDA-inspected sites supporting finished product and active pharmaceutical ingredients manufacturing, the company offers a wide variety of drug forms across multiple therapeutic areas. Zydus Cadila is dedicated to creating healthier communities globally and aspires to be a research-based pharmaceutical company by 2020.

Future of Zydus
Although Zydus Pharmaceuticals has grown tremendously over the past 13 years, the company is continuing to look for ways to bring value to the US market. Zydus Pharmaceuticals is aggressively pursuing new franchises to further its footprint in the lives of patients. The company has launched several products from its oncology facility and is planning on launching its first dermatologic product this year.

With the strength and worldwide reputation of Zydus Cadila supporting the US division, Zydus Pharmaceuticals aims to continue 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 success in the coming years.

To date, Zydus Pharmaceuticals has filed 127 drug master files, received final FDA approval on 184 ANDAs, received tentative FDA approval on 12 ANDAs, and has more than 130 ANDAs pending approval. The company also has about 300 additional products in various stages of development. Look for some exciting announcements from Zydus Pharmaceuticals over the next 12 months.
 
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