Earlier today the Spain-based contract research organization (CRO) gained Spanish Agency of Medicines and Medical Devices (AEMPS) to make commercial supplies of high-potency drug tablets at its pilot plant, which had previously only been cleared to produce capsules and tablets for clinical trials.
The extension – which builds on IDIFarma’s approval as a pharmaceutical services laboratory – follows the installation of several new manufacturing technologies at thew facility, including a GEA Niro spray dryer.
Spokesman Manuel Leal told Outsourcing-pharma.com that: “The plant is specially suitable for niche high potency drug products,” explaining that the facility has capacity to produce batch sizes of up to 60kg and that the plan is to target both Pharma firms and CMOs.
“Our new capabilities are ideal for smaller projects that may be a hassle for larger CMOs to accommodate and for Big Pharma firms developing high value drugs that only require two or three small batches a year.”
He added that while the focus is smaller-scale commercial manufacturing, IDIFarma is also capable of performing technology transfer to a larger manufacturing plant should the need arise.
This was echoed by company technical director Angel Ursua who set the approval extension in the context of IDIFarma’s wider business.
“This authorization will generate important advantages for products developed in IDIFARMA, whether generics, OTCs or innovative products, significantly reducing deadlines as well as risks in the pharmaceutical development.
“Moreover, it also allows us to introduce ourselves as an ideal commercial manufacturer for existing products that require a manufacturing facility like ours, either because they need small-sized batches or because of their high containment requirements.”