Gipharma Receives Broader Manufacturing Authorization
Press Release | Gipharma Srl
JUNE 05, 2014
Saluggia, Italy: – Gipharma Srl, a European reference contract manufacturing organization (CMO) of pharmaceutical drug products, announced today that it has received a renewed manufacturing authorization from the Italian Medicines Agency (AIFA) which now includes the categories of “Biotechnology products” (18.104.22.168) for investigational purpose, “Blood products” (22.214.171.124) and “Human or animal extracted products” (126.96.36.199).
This renewed manufacturing authorization follows a cGMP inspection by AIFA which resulted in a certification of Gipharma reconfirming its full compliance with EU standards for the manufacturing of sterile drug products at its Saluggia site in northwest Italy.
“We are proud to see that our efforts are being rewarded” commented Giovanni Ala, Gipharma’s founder and Managing Director. “Our customer-centric attitude is the key to our success in third-party manufacturing. The constantly enlarged product range in our manufacturing authorization reflects our ability to manage new challenges.”
Andrea Confetti, Gipharma’s Commercial Director, added: “In the past 11 years Gipharma has grown from 17 employees in 2003, when Gipharma was a spin-off of Sorin Biomedica’s Radiopharmaceutical Division, to 45 employees today. The company was acquired in 2009 by Advanced Accelerator Applications SA (AAA), an international specialist in Molecular Nuclear Medicine. The sparkle initiated by AAA has led to a three-year investment program of € 4.5 million, consisting of the acquisition of the previously rented site and in the doubling of our production capacity with the construction of a brand new sterile manufacturing suite. We continuously strive to widen our range of services without compromising on quality.”
The renewed and broader cGMP certification further consolidates Gipharma’s mission to operate as a reference CMO with an expertise and a capacity extending from early clinical stages to commercial production.
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/medium-sized product batches ranging from 5.000 to 14.000 vials. Gipharma specializes in oxygen-sensitive products such as radio pharmaceutical cold kits, for which it has a long-standing 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 out to support services in PET radiopharmaceutical manufacturing and testing. Gipharma is fully owned by Advanced Accelerator Applications SA, an international specialist in Molecular Nuclear Medicine.
Dr. Andrea Confetti, Gipharma Srl
Tel: +39 0161 487 141