Our pharmaceutical development and manufacturing facility is located in Cranbury, New Jersey, USA. We have the capacity to manufacture solid and liquid dosage forms including powders, tablets, capsules, solutions and suspensions. Our cGMP manufacturing facility is solvent-capable and equipped with state-of-the-art production equipment including multi-purpose fluid bed systems, tablet coater, high shear granulator, mills, capsule machine, packaging line, tablet press, blenders, and liquid mixing tanks.
Tulex’s Bioavailability Enhancement Sizing Technology
This platform technology focuses on bioavailability enhancement through particle size reduction by our proprietary micro milling technology. Unlike conventional nano-sizing technologies, which involve large equipment and lengthy processing time, our technology is highly efficient, reproducible, and provides narrow particle size distribution of the end products. It provides highly stable products with substantially higher rates of return on investment than traditional approaches.
This platform technology focuses on achieving pre-designed drug release profiles through our proprietary film/matrix forming process for specific drug delivery systems. Unlike conventional matrix and film controlled-release approaches, our innovative technology creates a unique process for programmable drug release profiles that can be tailored to meet specific clinical needs.
Tulex’s Gradient Release Enabling Advanced Technology
The competency of our core development team has been demonstrated through many ANDA (20+) and NDA (6+) approvals prior to the establishment of Tulex Pharmaceuticals Inc. These accomplishments include First-to-File Paragraph IV Generic applications in Extended Release dosage forms and the invention of a Proprietary Formulation Technology Platform leading to patent issuances (20+) and NDA approvals via 505(b)(2). To leverage those strengths, Tulex Pharmaceuticals Inc. now focuses on the development of Paragraph IV Generics with First-to-File status, high technical barrier generic drugs with limited competitors, and new drug applications through the 505 (b)(2) regulatory paths.
Our focus is on sophisticated modified-release dosage forms in order to be more competitive in the marketplace and to achieve a higher profit margin.
Our focus is on the development of NDA products using existing molecules in new dosage forms or via new routes of administration. Our objective is to enhance patient compliance, improve the safety and efficacy of the product and extend the product life cycle.EASYWELL BIOMEDICALS has taken full advantage of its experience in skin care, human physiology, and drug selection, to develop a transdermal patch to treat Parkinson’s disease using a molecule that was originally approved for oral administration. Our product is designed to improve patient compliance as well as the drug’s safety profile. This product is currently under clinical investigation.