Idifarma announced renewal of its EU-GMP certificate

| By | CDMO, GMP certificate, GMP Standards

Idifarma, a Spanish contract development and manufacturing organisation (CDMO) specialized in niche and highly potent products, announced the installation of GEA Niro Mobile Minor equipment in a new dedicated area in its EU GMP plant.

Idifarma is now offering GMP spray drying technology for highly potent drugs up to Category 4 OEL/OEB. The equipment is now installed and qualified and will give Idifarma spray drying capacity for niche commercial products and clinical batches.

Luis Oquiñena, general manager and co-founder of Idifarma, commented:

“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. 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 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. 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 specialised capabilities,” added Mr. Oquiñena.

Last inspection will allow Idifarma to continue offering its specialized contract manufacting and testing services for the pharmaceutical industry in EU-GMP territories. Idifarma’s new GMP certificate is valid until end of August 2021.

Idifarma is a leading Spanish CDMO since 2001 that provides services to over 100 international pharmaceutical companies. Idifarma is based in Noáin (Spain).

SOURCE: idifarma
GMP news
Pharmaceutical industry News and events. Technology transfer and contract manufacturing of medicines.