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Gipharma Obtain GMP Approval for New Injectables Production Line

news-releasesGipharma Srl
December 3rd 2013

Saluggia, Italy: – Reference Contract Manufacturing Organization (CMO) Gipharma Srl has gained full Good Manufacturing Practice (GMP) authorization for its new sterile injectables production line.

The cGMP certification includes authorization for investigational medicinal products (IMPs) and commercial supply to all EU markets.

The new sterile suite, now fully operational, doubles the production capacity of this young but rapidly growing company that offers a wide range of CMO services.

“We are delighted to have gained this seal of approval,” said Giovanni Ala, Gipharma’s founder and managing director. “It emphasizes our profile as a small company with a big reputation, capable of meeting the strictest standards for regulatory compliance and flexible, reliable and accurate manufacture.”

Mr. Ala said the renewed GMP authorization and expansion of injectable formulations production capacity would enhance the company’s production flexibility and was a vital stepping-stone to offer a state-of-the-art facility to new customers.

“This is a further consolidation of our mission to operate as a reference CMO with expertise and capacity that extends from early clinical stage to commercial scale production.

About Gipharma Srl
Based in North West Italy, Gipharma is a pharmaceutical contract manufacturer (CMO) for small volume injectable and freeze dried solutions, by aseptic as well as terminally sterilized processes. The company typically handles small/medium-sized lyophilized product batches ranging from 5.000 to 14.000 vials.

Gipharma specializes in oxygen sensitive products such as radiopharmaceutical cold kits for which it has a long-standing experience and supplies all leading imaging players in Europe.

Gipharma’s manufacturing license includes pharmaceuticals based on Small Molecules and biological APIs of human origin, while an extension to include biotechnological APIs is currently being evaluated by the Italian AIFA.

Gipharma is also a service provider for analytical assays and for sterility and endotoxin testing of Drug Products and can release Drug Products and IMP batches for Europe. Its expertise also extends out to support services in PET radiopharmaceuticals manufacturing and testing.

Gipharma Srl
Dr. Andrea Confetti, Commercial Director
Tel: +39 0161 487 363

For more information about Gipharma’s new sterile injectables production line, please contact Gipharma directly.

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