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Vitruvias Therapeutics Inc. Launches Shanghai-Based Sinotherapeutics’s Approved Version of Propafenone ER in the U.S.

2019年03月08日 PM09:00
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AUBURN, Ala. & SHANGHAI

Vitruvias Therapeutics Inc., an Auburn, Alabama-based finished-dose generic drug company, and Sinotherapeutics Inc., a Shanghai-based generic drug company, announced they have launched a bioequivalent FDA-approved version of Rythmol SR.

Rythmol SR, known generically as propafenone hydrochloride, is an antiarrhythmic drug supplied in extended-release capsules of 225, 325 and 425 mg for oral administration. It is indicated for the treatment of sustained ventricular tachycardia that is deemed to be life-threatening (NOTE: Dosage should be initiated in the hospital setting). It is also indicated for the conversion to and/or maintenance of sinus rhythm in patients with supraventricular arrhythmias without structural heart disease and for the maintenance of sinus rhythm in patients with paroxysmal atrial fibrillation or atrial flutter associated with disabling symptoms.

The Founder and CEO of Sinotherapeutics, Dr. Jason Wan, said, “We are pleased that we found Vitruvias. Like us, they are a young company, but they are growing rapidly through hard work, dedication and persistence in what is a very difficult U.S. market. We are confident they will maximize the value of our asset and we look forward to their future participation with other products in our very robust pipeline.”

Carl Whatley, Chairman and CEO of Vitruvias, added, “We are pleased to have found a Chinese partner with the resources and technical skills to formulate these high-barrier generics. Dr. Wan has put together a tremendous team in Shanghai and they are in the process of filing their many high-barrier ANDAs in the pipeline. The education and experience that Dr. Wan and his core technical and managerial team possess has prepared them to tackle both the scientific and business challenges of such a large, yet untapped market. China’s rapid entry into the global pharmaceutical markets is testimony to the modernization of China’s regulatory system and the repatriation of many experts like Dr. Wan.”

About Vitruvias Therapeutics

Vitruvias Therapeutics is a generic pharmaceutical company which utilizes domestic and international partnerships to develop, manufacture, and market generic products. Founded in the southern U.S. 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 currently markets several generic products in the U.S. The company received its first approval in September 2017, and anticipates several additional ANDA applications will be filed during 2019. www.vitruvias.com

About Sinotherapeutics

Sinotherapeutics Inc. is a specialty pharmaceutical company focused on developing generic products that are of high commercial value and possess high technological barriers. Founded in 2012, the company is integrated with R&D, regulatory affairs for product registration (FDA and NMPA), clinical supply and commercial manufacturing, and sales and marketing capabilities. The company has several business units including their R&D Center, located inside the Shanghai Institute for Advanced Research, Pudong Zhangjiang district, and Haimen Pharma Inc., a wholly owned subsidiary, located in Jiangxu province, Haimen City which serves as their manufacturing site for clinical and commercial supply. The company has successfully developed and launched several controlled and delayed release ANDAs for the U.S. and Chinese market. www.sinotherapeutics.com/En/Index/index.html

View source version on businesswire.com: https://www.businesswire.com/news/home/20190308005020/en/

CONTACT

Sara Caldwell
Media Relations
Vitruvias Therapeutics Inc.
Phone
+1 (334) 329-5601
sara@vitruvias.com

Hui
Zhang
Public Relations
Sinotherapeutics Inc.
Phone +86 21
6881 9009 – 806
zhanghui@sinotph.com

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