The installed spray drying capacity is for handling highly potent drugs of up to Category 4 OEL/OEB
Idifarma has announced that its installed GMP spray drying technology for highly potent drugs (HAPIs) is now operational at its plant in Navarra, Spain. A contract development and manufacturing organisation (CDMO), Idifarma specialises in niche and highly potent products.
In April this year, Idifarma installed a GEA Niro Mobile Minor equipment in a new dedicated area in its 4,000sqft EU GMP plant. The equipment can handle HAPIs up to Category 4 OEL/OEB.
Now in operation, Idifarma is one of only three companies in the world offering this type of contract development and manufacturing spray drying service.
The equipment has been 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 oral solid drugs through to finished dosage forms," said Luis Oquiñena, General Manager and co-founder of Idifarma.
Oquiñena said the new equipment is Idifarma's latest strategic investment 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," he said.
This announcement follows investment in both serialisation and capsule filling capabilities and strengthens Idifarma’s position as a specialised 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," Oquiñena concluded.