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Gipharma - Quality and Flexibility in Lyophilized Parenterals Manufacturing

Gipharma was established in 2003 as spin off of Nycomed Amersham Sorin S.r.l. and is located in the North-Western Italian town of Saluggia (VC), a small town between Turin and Milan. Gipharma is authorized to produce and release for Europe small volumes parenterals, liquid and lyophilized (commercial products and IMP)

Contract manufacturing of injectable drugs for pharma companies

Since 2008 Gipharma is part of Advanced Accelerator Applications Group, a European leader in PET Radiopharmaceuticals and Radiometabolic Therapy.

Gipharma main business is represented by contract manufacturing of injectable drugs for pharma companies, among them GE Healthcare, Covidien, Synermed, IBI.

Furthermore it produces some proprietary products including generic SPECT radiopharmaceuticals, and a medical device for sterile separation and labeling of authologous white blood cells for Nuclear Medicine imaging.

Substantial experience in manufacturing of oxygen sensitive products

Thanks to its long standing history of radiopharmaceuticals production (as Amersham and Sorin Biomedica) Gipharma gained a substantial experience in manufacturing of oxygen sensitive products.

The Company has also extended its manufacturing authorization to products containing API of human and animal tissue origin and to manufacturing of clinical trial batches.

gipharma

Parallel to the production of freeze dried injectable products, Gipharma has developed a supply of GMP produced sterile vials in a large variety of formats and a GMP microbiological test service for PET centers throughout Europe.

Examples of sterile vials are:

  • Evacuated vials
  • Nitrogen filled vials
  • Sterile stoppered /sealed vials for filling of small batches of PET or Biotech products

Microbiological tests range from sterility tests, environmental controls, microorganism identification to endotoxins content determination.

As a third party manufacturer Gipharma also gained large experience in technology transfer, process validation and analytical test validation and can provide a flexible and fast service.

A second sterile filling/lyophilization line installed to increase its production capacity

Gipharma has recently completed the installation of a second sterile filling/lyophilization line to increase its production capacity. Its freeze drying capacity is represented by two freeze driers (6.5 sqm shelves each) plus a smaller one used for freeze drying cycle developments.

Current production capacity is around 6 million vials (including lyofilisates, sterile vials and solutions)

With its increased production capacity and long standing experience, Gipharma is therefore able to offer a wide range of CMO services:

  • Production of small volume lyophilized and sterile liquids in vials
  • By aseptic manufacturing and terminal sterilization
  • For commercial and clinical trials batches
  • Technical Transfer and ICH Methods Validation
  • Finished products and raw materials testing
  • Microbiological testing
  • Batch release for Europe
  • ICH Stability Studies and storage

Contact

GIPHARMA S.r.l
Strada Crescentino snc 13040
SALUGGIA (VC)
ITALIA
Tel.+39 0161 487141
Fax +39 0161 487140
E-mail: info@gipharma.com
URL: www.gipharma.com