Pediatric Dosage Formulation

A global biopharmaceutical company with a successful adult anti-infective product franchise was looking to create a pediatric formulation to meet US FDA regulatory requirements, expand patient access to children in an appropriate dosage form and strength, and to extend patent protection of its flagship product line.

The pediatric formulation and dosage form(s) in development at small/lab scale did not fit the plant equipment profile used to manufacture the adult dosage form at the customer’s facility. The customer, therefore, required a high-quality, agile CDMO with experience supplying international markets that could manufacture its pediatric formulation on the same equipment train used for manufacturing its adult dosage form.