Recro Wins $1.5M Formulation Development And Cgmp Manufacturing Contract To Support Clinical Development Of Topical Treatment For Skin Cancer Prevention
Recro Pharma, Inc., a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced that it has been awarded a new formulation development and cGMP manufacturing contract from a key department of the United States government. The contract focuses on supporting clinical development of a topical dermal treatment for the prevention of skin cancer.
Under terms of the new, multi-year, $1.5M contract, the company will formulate, manufacture and supply a topical dermal drug product containing a prespecified active pharmaceutical ingredient, as well as a matching placebo, for a planned cancer prevention clinical study. These activities will include analytical method development, formulation, cGMP clinical trial material manufacturing, packaging and labeling services to support the planned clinical trial, which is designed to evaluate the effects of chemoprevention with the investigational compound on the recurrence of basal cell carcinoma.
“We are pleased to have been selected to support this important clinical research program focused on a preventative skin cancer therapy. The scope of work associated with this new contract will allow Recro to call upon a broad range of our capabilities from analytical development and formulation through to key clinical trial material manufacturing and packaging,” said David Enloe, chief executive officer of Recro. “This agreement is the latest evidence of the traction our sales team is generating in growing our base of business, which includes key relationships with not only pharmaceutical and biotech companies but also important federal government agencies.”
About Recro
Recro is a bi-coastal contract development and manufacturing organization (CDMO) with capabilities spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms with a primary focus in the area of small molecules. With an expertise in solving complex manufacturing problems, Recro is a leading CDMO providing therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market.
In addition to our experience in handling DEA controlled substances and developing and manufacturing modified-release dosage forms, Recro has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, which total 145,000 square feet, in Gainesville, Georgia and San Diego, California.
For more information, visit recrocdmo.com.
Source: Recro Pharma, Inc.