Idifarma’s GMP spray drying technology for highly potent drugs up to Category 4 OEL/OEB is now operational.
The Spanish contract development and manufacturing organization (CDMO), which specializes in niche and highly potent products, is one of only three companies in the world offering this type of contract development and manufacturing spray drying service with the installation of GEA Niro Mobile Minor equipment in a new dedicated area in its 4,000 sq. ft EU GMP plant.
The equipment is now installed and qualified and will give Idifarma spray drying capacity for niche commercial products and clinical batches.
“We are at the forefront of spray drying technology, providing contract manufacturing services for intermediate products and for oral solid drugs through to finished dosage forms,” Luis Oquiñena, general manager and co-founder of Idifarma said. “This is the latest strategic investment for Idifarma and is driven by significant client demand as the market looks for spray drying solutions to improve the bioavailability of poorly soluble drugs. Idifarma is proud to support our customers’ spray drying projects at different scales and contribute to accelerated drug development and manufacturing timelines.”
This announcement follows investment in both serialization and capsule filling capabilities and strengthens Idifarma’s position as a specialized contract partner for the development and manufacturing of oral solid dosage forms, including high potency compounds and niche pharmaceuticals requiring small commercial and clinical batches.
“We recently reported another successful inspection by Spanish authorities which means Idifarma will continue to offer EU GMP manufacturing and analytical services to our clients. Combined with our continued investment in new technologies this reflects our ongoing success within the CDMO market and our intent to further grow our business with specialized capabilities,” Oquiñena said.