Tris Pharma Announces Acceptance Of Its First Two NDAs
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Tris Pharma, a privately owned speciality pharmaceutical business that develops innovative narcotic delivery technologies, announced that the US Nourishment and Drug Governance (FDA) has accepted its first two Different Drug Applications (NDAs) for once-daily formulations of a cardiovascular drug. If approved, Tris Pharma's liquid and solid dosages will cater an alternative to the currently available prompt release, twice-a-day tablet.
LiquiXR(TM) is the liquid dosage form of the company's proprietary OralXR platform. Only two long proceeds liquid pharmaceuticals exist today. Provided FDA approves Tris' liquid formulation, it will be the early sustained release liquid commercialized in bounteous than 25 years and the first-ever liquid dosage fashion available in a 24-hour lingering release formulation.
"LiquiXR offers the compliance and convenience benefits of other controlled release dosage forms and allows physicians a limitless number of dose options since the potion can be customized through titration," says Dr. Yu-Hsing Tu, Tris' Sense of R&D. "This will be particularly hot as the technology is leveraged in the augmenting of CNS, pain, and other narrow therapeutic window compounds."
The company's OralXR platform also includes other dosage forms such as ODT, chewable tablets, and movie strips. Using these technologies, Tris Pharma is developing products that are targeted toward pediatric and geriatric populations and other patients who hold matter swallowing a traditional "pill."
"FDA's acceptance of our two NDAs validates Tris' OralXR platform, and is an crucial milestone for the company," says Tris Pharma CEO and Founder Ketan Mehta. "We have an eye-popping future, with a robust pipeline of enhanced than 20 extensive release products in different therapeutic categories currently in development."
Tris' drug delivery technology also offers other improvements over those used for the older products. To manufacture the cardiovascular drug, the collection uses a safe water-based process, replacing the necessitate for the poisonous biological solvents used in the older products. This new aqueous solvent, coupled with Tris' patent-pending manufacturing process, again improves product stability and batch-to-batch uniformity.
About Tris Pharma:
Tris Pharma is a privately owned, product-focused, specialty pharmaceutical company busy in the test and system of innovative drug delivery technologies. Through its OralXR platform, Tris has pioneered the delivery of sustained release in the liquid, chewable/ODT and strip dosage forms where by patients engage in not have to swallow a pill. Tris' Nobuse platform provides abuse-deterrence for opioids and other abuse-prone drugs. The company has else than 30 Rx and OTC products in development with pharmaceutical partners. Tris' R&D and manufacturing facilities are located in Monmouth Junction, New Jersey.
Source: Tris Pharma
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