Frontida BioPharm Receives FDA Clearance and Launches Expansion Efforts
May 10, 2017: Frontida BioPharm, Inc. a Contract Development and Manufacturing Organization located in Philadelphia, PA and Aurora, IL announces that the Food and Drug Administration (“FDA”) has issued a closure letter for its Philadelphia manufacturing site on May 4, 2017. The closure letter was received only 8 months after the FDA issued a Warning Letter to Frontida based on an FDA inspection of the site occurring between June 15 and July 17, 2015, prior to Frontida’s purchase and operation of the facility.
Frontida also announces the launch of their operations expansion initiatives. Since acquiring the facilities on June 3, 2016, Frontida retained 155 positions at the existing sites and added more than 65 quality and scientific professionals. With the implementation of Quality System improvements across the organization, Frontida plans to hire an additional 40-50 personnel in the next 6 months as it begins to launch new products in its Philadelphia and Aurora facilities.
“Philadelphia is a great region for Frontida to build our organization due to its strong talent pool and pharmaceutical research heritage. Over the past 11 months, Frontida has built a strong foundation by providing new leadership, expanding our manufacturing, QC, and R&D work force, and improving operational and quality systems,” said Dr. Song Li, CEO of Frontida BioPharm. “We are continuing to expand our capabilities with additional manufacturing and laboratory personnel, equipment, and capital investments. The positive resolution of our regulatory status with the FDA will stimulate Frontida’s expansion and growth, and enable Frontida to better support our partners to bring new products to the market.”
Frontida BioPharm, Inc. is a leading provider of drug delivery technologies, product development and manufacturing services for both small and large pharmaceutical and consumer health companies. Combining the rich heritage of resources from URL/Mutual Pharmaceuticals in Philadelphia, PA and Aurora, IL with the development expertise from Frontage Laboratories and the region’s best pharma companies, Frontida is helping our partners reach the market faster, ensuring robust product performance and on-time supply of clinical and commercial supply. Our 300,000+ ft2 manufacturing facilities supply prescription and OTC products, Highly Potent Active Ingredient (HPAI) products, Fixed-dose Combination Products and DEA schedules II – V products. Our 4 packaging lines, including one with validated product serialization, provide packaging services for both commercial products and clinical trial material supplies. Frontida is working with Philadelphia and Pennsylvania officials to implement job training programs for skilled workers and support the region’s efforts to retain highly talented pharmaceutical professionals. Frontida – Quality Manufacturing, Extraordinary Care.™ Visit www.frontidabiopharm.com for more details.