AUBURN, Ala. & TAIPEI, Taiwan--(BUSINESS WIRE)--Vitruvias Therapeutics Inc., an Auburn, Alabama-based finished-dose generic drug development company, has agreed to license an approved Potassium Chloride Extended release ANDA. The product will be manufactured by Bora Pharmaceutical’s Zhunan site, which was recently acquired from Impax.
Carl Whatley, Chairman and CEO of Vitruvias stated that “as a 40-year veteran if this industry, I have toured many manufacturing facilities, and Bora’s Zhunan facility is one of the best I have ever seen. Being a relatively new facility and having the responsibility and FDA approval for the manufacturing of Impax’s U.S. products, its size, quality systems, state-of-the-art high volume equipment and highly responsive personnel make it a logical choice for our portfolio of technically complex oral solids.”
“Bora Pharmaceuticals is honored to be in business with Vitruvias. Their experienced management team has a stellar track record of successful product launches and their pipeline of products has positioned the company for explosive growth. We are excited to show our large-scale solvent capabilities and to give Vitruvias a high-quality competitive product in the market. We look forward to a long-term relationship with them,” says Bobby Sheng, Chairman and CEO of Bora Pharmaceuticals.
Potassium Chloride Extended Release tablets are used to prevent or to treat low blood levels of potassium (hypokalemia). Current annual sales1 of all forms of Potassium Chloride Extended Release tablets totaled approximately 1.66 billion tablets through September 2018.
This is the first contract manufacturing agreement between Vitruvias and Bora.
Vitruvias is a generic pharmaceutical company which utilizes domestic and international partnerships to develop, manufacture, and market technically difficult generic products. Founded in 2013, the company’s primarily focus is on products in the generic sterile injectable market, semi-solid market, and selected high-value oral solids. The Company received its first approval in September 2017, and anticipates additional approvals in late 2018 and early 2019. www.vitruvias.com
Bora Pharmaceuticals (TSE: 6472) is a publicly traded, Taiwan based, pharmaceutical company that covers the entire pharmaceutical value chain from CDMO services to marketing and sales. Bora has a solid financial foundation, experienced management team, and long-standing partnerships with best in class multinational Pharmaceutical companies. Bora, and its subsidiaries produce, market, and sell products ranging from Generics, Consumer Health, and In-Patent Branded Drugs. In addition, Bora Pharmaceuticals' U.S. FDA, PIC/S and GMP certified plants provides large scale outsourced R&D and contract manufacturing services to over 16 countries worldwide. https://cdmo.bora-corp.com
1 Source: IQVIA, National Sales Perspectives, Sept 2018