Certified and inspected by pharmaceutical authorities.
GMPCompliance AIFA
GMPMinistry of Health
FDAApproved facility
CEMedical devices
ISO 9001:2015Quality Management System
ISO 13485:2021Medical Devices
UNI/PdR 125:2022Gender Equality
FarmindustriaMember
About us
In the heart of Tuscany
Industria Farmaceutica Galenica Senese, located in the heart of Tuscany, is a manufacturing company specialised in the production of infusion and injectable medicines: loco-regional anaesthetics, saline, glucose, electrolyte, Ringer, mannitol, glycerol and sodium bicarbonate infusion solutions, to restore the hydro-saline and energy balance of hospital patients.
And more: amino acid solutions, infusion solutions for pain therapy such as paracetamol, iopamidol and contrast media for radiology, antibiotics in bags, veterinary solutions, life-saving medicines such as adrenaline and noradrenaline, sedatives for infusion such as dexmedetomidine, dialysis fluids — these are just some of the many formulations the company is able to produce and make available to its partners.
1949
Since
134
Marketing Authorization products
21
Therapeutic categories
100%
Made in Tuscany
Company
Mission
Our mission: to make our expertise and reliability available to our customers. Our sales force is present in Italian Hospitals, Care facilities and Pharmacies. Our strength: a Research & Development laboratory working with prestigious Italian and US university research centres, a product quality control laboratory and a regulatory office that can work alongside our partners.
Our export sales office ships our products all over the world, assisting our customers both from a regulatory standpoint and in the preparation of the dossier, including in foreign languages.
Clean rooms, terminal sterilization, quality control on every batch.
The manufacturing process
How a sterile solution is born
From formulation to the packaged vial: every stage is validated and controlled, inside our facility in Monteroni d'Arbia.
01
Preparation
Solution preparation in dedicated equipment
02
Filling & sterilization
Cleanroom lines, terminal sterilization
03
Quality control
Inspection and analysis on the finished product
04
Packaging
Ampoules, vials, bottles, pre-filled syringes and bags
Production
Control over the whole process, through to the finished product.
Our production is built around Good Manufacturing Practices, with chemical and microbiological analysis laboratories and a quality system integrated with international standards.
Facility compliant with Good Manufacturing Practice (GMP)
GMP also for Investigational Medicinal Products (IMP)
Recognised by independent auditors as an Italian centre of excellence
Industria Farmaceutica Galenica Senese is a leader in Contract Manufacturing for the pharmaceutical sector and offers other companies its facilities and the professionalism of its staff for third-party manufacturing, in compliance with the highest international quality standards, backed by the know-how built over years of experience and by the use of innovative technology.
We can support you through the registration dossier process, production validations and stability studies.
In particular, we can support our customers with:
Characterisation of the active ingredient
Preparation of pilot batches
Preparation of scale-up batches
Analytical development
Validation of analytical methods
Stability studies in accordance with ICH standards
Therapeutic nanomaterials with optimized delivery, in partnership with Ca' Foscari University of Venice. An investment of over 5 million euros in innovation.
Project co-financed by the European Union · Ministry of Enterprise and Made in Italy · CUP B99J23000440005
Batch certificates of analysis, price lists and materials for representatives reserved for healthcare professionals and registered customers. SmPCs and package leaflets are public on the Italian Medicines Agency (AIFA) medicines database.
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