By Gipharma Srl
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Gipharma Receives AIFA’s Green Light for Warehouse Expansion
Saluggia, Italy: – Gipharma Srl, a European reference contract manufacturing organization (CMO) of pharmaceutical sterile drug products, announced today that it had received formal authorization from the Italian Medicines Agency (AIFA) to expand its warehouse for raw materials, primary packaging components and ancillary equipment.
This authorization follows AIFA’s review of the documentation package that Gipharma submitted to substantiate full adherence to cGMP across each and every phase of the project.
With an additional storage surface of 190 m2 over two floors, Gipharma’s new warehouse also enables a smoother flow of materials to feed the two production lines, in full compliance with the expectations of customers and regulatory bodies.
“Following authorization of our second production line, we identified the warehouse as the remaining bottleneck in supporting our updated offer,” commented Giovanni Ala, Gipharma’s founder and Managing Director. “We constantly strive to widen and improve our offer to customers and our investments are focused accordingly.”
Andrea Confetti, Gipharma’s Commercial Director, added: “In 2014 we produced more than 2.2 million vials over 280 batches, of which 42 per cent were lyophilized products. In parallel, our laboratories successfully managed to handle an unprecedented load of third-party services, with 8300 sterility and 7000 radio chemical purity tests.”
Positioning itself asa CMO with an expertise and a capacity extending from early clinical stages to commercial production, Gipharma currently employs 46 people.
About Gipharma Srl
Based in Saluggia, northwest Italy, Gipharma is a pharmaceutical contract manufacturing organization (CMO) for small volume injectable liquids and freeze-dried powders (aseptic and terminally sterilized processes). The company typically handles small to medium-sized product batches ranging from 5.000 to 14.000 vials. Gipharma specializes in oxygen-sensitive products such as radio pharmaceutical cold kits, in which it has long-established experience and supplies all leading imaging players in Europe.
Gipharma is also a service provider for analytical assays and for sterility and endotoxin testing of drug products and can release drug product and investigational medicinal product batches for Europe. Its expertise also extends to support services in PET radio pharmaceutical manufacturing and testing.
Gipharma is fully owned by Advanced Accelerator Applications, an international specialist in Molecular Nuclear Medicine.
More information at: www.gipharma.com