Vitruvias Therapeutics And Sunny Pharmtech Receive First FDA Generic Drug Approval
Published: Sep 27, 2017
AUBURN, Al. & TAIPEI, Taiwan--(BUSINESS WIRE)--Sunny Pharmtech Inc., a Taiwan-based API and finished-dose drug development company, and Vitruvias Therapeutics LLC, a generic drug development company, announced they have received approval of their abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) for Lidocaine Ointment USP 5%.
This is the first generic approval for both companies and is part of a joint development agreement that now includes eight products. The joint application was filed in November of 2016, and received first-cycle approval after a 10 month review.
“We are pleased to have received such a timely approval with our first jointly filed application,” said Dr. Yon-Lian Wu, Sunny Pharmtech’s CEO and Chairperson. “It is a testament to competence and capabilities of both companies’ development and regulatory groups that our first application was approved so quickly”.
Carl Whatley, General Manager of Vitruvias added, “It is very exciting to receive our first joint approval, and we are looking forward to beginning the commercial phase of our business plan. This approval represents our transition from a purely developmental company to one that can discover, develop and commercialize technically complex generics."
About Sunny Pharmtech Inc.
Sunny Pharmtech Inc. is an emerging specialty pharmaceutical company based in Taiwan and was founded in 2004 with a focus on the development of technically difficult products. In 2014, the capability of developing and producing active pharmaceutical ingredients was added. The resulting organization is now fully-integrated, doing research, development, and manufacturing on both API and finished-dose products which includes orals, liquids, semi-solids, and parenterals. www.sunnypharmtech.com/home/
About Vitruvias Therapeutics LLC
Vitruvias is an emerging specialty pharmaceutical company which develops, manufactures, and markets generic prescription products for the U.S. and Canadian markets. Founded in 2013, the privately-held company specializes in generic semi-solid and parenteral products. The current focus of the company is on the development of selective, high-value generic products. www.vitruvias.com