Fisiopharma is a CDMO dedicated to development and manufacturing of injectable products. The first production site is located in Italy. Supported by almost fourty years of experience in injectable field Fisiopharma can support customers and partners for the entire production process, from receipt and analysis of raw materials to secondary packaging/serialization and release of thr product, including providing of regulatory services, analytical development, validation services and more. Main Fiopharma unique features are:

- Broad international approvals (EMA, US-FDA, Anvisa, NMPA, Saudi-FDA, South Korea and planned PMDA);- Customer oriented, proactive and flexible attitude that allows Fisiopharma to support international customers of different types and dimensions and located worldwide;- Special authorization for some products (i.e. biologics, corticosteroids, narcotics, products for clinical purpose);- Deep knowldege and experience in manufacturing of sterile suspensions.

Fisiopharma first site is located in Italy (Palomonte, Salerno Province) and dedicated to manufacturing of sterile solutions and suspensions in vials and ampoules and filling of sterile powder. An expansion of the site has just started and is planned to be completed in next years increasing capacity for sterile liquids in vials and introducing pre-filled syringes capability. The Italian site is approved by all the main regulatory authorities including EMA/AIFA, US-FDA, Anvisa, NMPA and others.

In addition to the Italian site a second site is located in Hefei, China. The site, originally supporting mainly Chinese market, has recently gained approval from AIFA for the first sterile ampoule lines and plans to gain additional international approvals of other lines in the near future. The Hefei site offers broad capacity in manufacturing of sterile solutions in ampoules and vials, of FD products and of oral solids, including high potent products.

Together Palomonte site and Hefei site can offer to customers a broad offer in CDMO services.

Type of Drugs Manufactured:

Small Molecule;Biologics

CDMO Services:

Drug Product Formulation (FDF);Aseptic Fill Finish;Packaging;Regulatory Services;Analytical Development

No. of Manufacturing Facilities:

2

Facilities Locations:

Europe;China

Regulatory Approvals for facilities:

FDA (United States);EMA (Europe);GMP;NMPA (China);Health Canada;ANVISA (Brazil)

Manufacturing Technologies:

Lyophilized amps/vials;Solids;Sterile Ampoules;Sterile Vials

Current Capacity:

Palomonte site currently offers broad capacity in manufacturing of terminal sterilized ampoules and sterile powders and medium capacity for vials and ampoules manufactured in aseptic conditions. By beg of 2027 with readiness of the new manufacturing site dedicted to solutions in vials and pre-filled syringes Palomonte site will offer huge capacity for these products (>20Munits/year of ampoules and vials).
Hefei site offers currently broad capacity for all the product types.