Noramco, a global leader in the manufacture and supply of controlled substance active pharmaceutical ingredients (APIs), and SPI Pharma, a global leader in the manufacture and supply of functional excipient platforms and the development and licensing of unique dosage forms, have signed an agreement to develop and license a set of “value-added” formulation packages for global pharmaceutical manufacturers of finished dosage forms.
The agreement will focus on finished dosage products for licensing to customers through dossiers developed by SPI Pharma for implementation by generic and branded pharmaceutical companies. Neither Noramco nor SPI has any intention to produce or market finished dosage forms.
“Bringing together Noramco’s expertise in API production with SPI Pharma’s know-how in formulation development and technology transfer allows us to create compliant, novel dosage forms, ready-to-implement at a site of our customers’ choosing,” said Bill Grubb, Vice President of Global Strategy and Innovation, Noramco.
SPI Pharma’s Chief Scientific Officer, Sarath Chandar, said, “We expect to create a winning formula for pharma customers worldwide through the combination of SPI’s strong track record of developing and licensing successful 505b(2) type drug packages featuring our patented platforms and Noramco’s proprietary API technologies.”
Noramco and SPI Pharma will demonstrate proof-of-concept (POC) of a select set of finished drug products in patient-friendly dosage forms, which will be out-licensed to customers for scale-up, registration, and marketing. Customers can also choose upfront to customize formulation packages for specific APIs on a milestone-based, pay-for-success business model.
“Pharmaceutical companies that normally purchase APIs from Noramco but have an additional need for speed-to-market, a reduction in trial-and-error, product differentiation, life-cycle management, and technical/regulatory support may now call on us for comprehensive formulation packages,” Grubb said.