CellPort Celebrates FDA Approval for Sucralfate Oral Suspension

A Generic Drug Product by Clayton Pharmaceuticals and VistaPharm (a Vertice company)

Exton, PA- <April 7, 2022> – CellPort Software, a leading provider of laboratory management software specially designed for working with cells, was credited as a contributor in a recent press release from Clayton Pharmaceuticals and VistaPharm (a Vertice company) regarding the FDA approval of Sucralfate Oral Suspension.

Scott Meyers, CEO of Vertice, shared "I am proud that the strong collaboration between our companies has resulted in an FDA approval for Sucralfate Oral Suspension. Congratulations also for the outstanding operational execution that resulted in us quickly receiving CGT designation for this product following FDA approval."

Dr. Sid Bhoopathy, the President and CEO of Clayton Pharmaceuticals, commented "This ANDA approval using well‑designed, scientifically sound in vitro bioassays endorses the use of novel approaches to demonstrate product bioequivalence. It is a proud moment for Clayton and our partners, VistaPharm and Neuheit. We are buoyed by the approval of this product and ready to solve the bioequivalence challenges for the next set of complex products."

Both CellPort Software and Absorption, a Pharmaron company, provided testing and analytics support during the development process of this generic drug product. According to the press release, U.S. annual sales for Sucralfate Oral Suspension for the 12 months ended December 2021 were $188.5 million, of which $157.9 million represents generic sales.

The author of the press release notes, “The approval of this product, … marks a paradigm shift in how complex generic drug products can be commercialized without the need for expensive, long-drawn, and sometimes non-viable clinical studies.”

Instead of clinical studies, the FDA approval for this product involved the initial development of twelve different bioassays that tracked the product's postulated clinical interactions using in vitro biology. This in vitro method allows companies to replace human and animal testing with testing on human cells.

Patrick Dentinger, CellPort Software CEO, commented “We are proud to have worked with Clayton Pharmaceuticals and VistaPharm on this FDA approval. It marks a significant improvement for drug development, and demonstrates how the digitalization of cell manufacturing plays a factor in the digital transformation of biopharmaceuticals.”

About CellPort

Lab-tested since 2014, CellPort is the all-in-one lab management platform that brings digital capabilities, like automated workflows, protocol builders, e-batch records, central communications, and more, to cell-based life sciences. Based in Philadelphia.

For more information, and to learn about CellPort’s leadership team, please visit cellportsoftware.com.