Gipharma cGMP Filling and Lyophilization services
Products & Services | Gipharma Srl
The modern Gipharma production site is cGMP certified for manufacture of investigational medicinal products (IMPs) and commercial products.
These include oxygen-sensitive products, like radiopharmaceuticals in which Gipharma has near-unrivalled experience, as well as biologicals and biotechnologicals.
Authorized Manufacturing Operations
Gipharma’s range of sterile injectable drug products include:
- Aseptically prepared lyophilisates
- Aseptically prepared small volume liquids
- Terminally sterilized small volume liquids
Gipharma’s portfolio of biological medicinal products include:
- Blood products
- Human or animal extracted products
- Biotechnology products, for IMP purpose
Sterile Small Volume Liquids
Gipharma currently manufactures injectable solutions in small vial format (up to 100 ml size) with a capacity up to 30.000 vials per day.
Gipharma manufactures a wide range of injectable lyophilized drug products, with a batch size up to 13.000 vials.
Radiopharmaceutical Cold Kits
Gipharma holds a specific authorization to produce cold kits, which are freeze-dried compounds intended for use in Nuclear Medicine, upon reconstitution at end user side with a labelling solution containing a radioactive isotope.
Other services for Nuclear Medicine
Gipharma is able to support the Positron Emission Tomography (PET) centers with a complete range of cGMP-compliant services, such as:
- Supply of Sterile Evacuated Vials
- Supply of sterile saline solutions
Quality Control Testing, including radioactive compounds
- Media fill, including their supply
- Radionuclidic purity