The following production formats are managed at the Fisiopharma site:
– Solutions and suspensions in vials from 2 ml to 100 ml;
– Solutions and suspensions in ampoules from 1 ml to 20 ml;
– Sterile powders in vials from 5 ml to 100 ml.
In addition to glass vials, plastic vials are also processed.
CONTRACT DEVELOPMENT & MANUFACTURING Our Contract Manufacturing business has grown steadily over the years and is currently the area of greatest commercial expansion. Initially focused on Italian and European clients, Fisiopharma now includes international pharmaceutical companies of different types and sizes in its portfolio, from small and medium-sized companies to big Pharma. We view our customers as real partners, with whom we develop long-term business programmes based on multiple projects. Technical expertise, 30 years of experience in the production of injectable drugs, including complex formulations, and a constant focus on quality together with a proactive, efficient and fast approach are our hallmarks. Molecules produced: Fosfomycin, Heparin, Dobutamine, Triamcinolone, Furosemide, Amikacin, Erythromycin, Bupivacaine, Midazolam, Lidocaine, Chloramphenicol, Nitroglycerin, and others. In addition to commercial production, Fisiopharma offers a wide range of CDMO services, such as: 1 1 formulations and processes With a PM&D (Product Monitoring and Development) department dedicated to studying new formulations, Fisiopharma fine-tunes and develops new products according to ICHQ8 ‘Pharmaceutical development’ requirements. Among its activities, Fisiopharma carries out DoE (design of experiment) studies specific to each product. 2 2 analytical methods Development, validation and transfer of chemical methods using HPLC UV VIS detectors, HPLC detectors (CAD), HPLC amperometric detectors (ECD), UPLC UV VIS detectors, GC detectors (FID), GC headspace detectors (FID), UV VIS spectrophotometers, IR spectrophotometers, and vial integrity testing. Development and validation of microbiological methods for endotoxins analysis (gel clots), bacterial count, sterility, antibiotic assay and anticoagulant activity of Heparin. 3 3 validation The validation activities required by each project are performed in-house by qualified personnel. These include: process validation, media fills, smoke tests, equipment validation, and terminal sterilisation validation. 4 4 Lots Both pilot and full-scale technical and registration batches are produced in Fisiopharma’s production departments. Depending on the type of product, production process and equipment used, the batch size can vary from a few dozen litres up to 500 litres. Fisiopharma is also authorised for the aseptic production of small volumes of liquids for clinical trials. 5 5 Packaging Single and multi-packs are available, including the use of PVC trays. Fisiopharma serialises pharmaceuticals for a number of markets, including EU, Saudi Arabia and USA (including aggregation). Fisiopharma is working to implement serialisation for Korea and China. 6 6 registration dossiers Thanks to an internal Regulatory Department, Fisiopharma supports customers with the preparation of registration dossiers for Europe, USA and other markets, in accordance with existing regulatory requirements, including the conversion of the dossier into eCTD format, if required. In addition to dossier preparation, Fisiopharma supports the definition of regulatory/registration strategies. 7 7 Projects Each project is managed by a dedicated project manager, who follows the customer through the various project phases by monitoring and controlling activities and schedules, providing problem solving and providing regular updates using the main project management tools. Batch sizes vary according to production process and vial and range from a few thousand units up to more than 100,000 units per batch.
CDMO
Market
Fisiopharma is a major player in the Italian Contract Development & Manufacturing Organisation (CDMO) sector, which exceeded €2 billion in production value in 2020 and ranks first place in Europe with a share of 23% (Source: Farmindustria 2022).
What sets us apart
Products
Fisiopharma manufactures various types of non-cytotoxic products, including local and systemic anaesthetics, non-beta lactam antibiotics, antiarrhythmics, systemic anti-inflammatory, anticoagulants, products of biological origin.
Our range of services
Fine-tuning and development
of formulations and production processes
Development, validation and transfer of analytical methods
Validation and
qualification activities
Production of technical and registration batches and lots for clinical trials
Secondary packaging and serialisation
Preparation of
registration dossiers
Project management
Batch sizes and production formats
In addition to commercial batch sizes, small-/pilot-scale batches are also produced for technical and registration purposes.
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