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Italian pharmaceutical manufacturer since 1949

Precision
that heals.

Sterile infusion solutions and injectable medicines for hospitals and healthcare professionals. Made in Tuscany to Good Manufacturing Practice standards, since 1949.

FDA GMP ISO 9001 ISO 13485 ISO 14001 CE 0373
Compliance & accreditations

Certified and inspected by pharmaceutical authorities.

FDA Approved facility
Certificazione ISO 9001:2015 — URS/UKAS ISO 9001:2015 Quality Management System
Certificazione ISO 13485:2016 — URS/UKAS ISO 13485:2016 Medical Devices
GMPISO 14001CE 0373FarmindustriaWHO · PIC/S · ICH
About us

Seventy years of pharmaceuticals, one single obsession: sterility.

Since 1949 we have produced sterile parenteral solutions at our facility in Monteroni d'Arbia, near Siena. Every batch is born from GMP-validated processes and a quality control that admits no exceptions — because it ends up in patients' veins.

1949

Since

195

Products in catalog

21

Clinical categories

100%

Made in Italy

Inside the facility

See how a sterile medicine is made

Clean rooms, aseptic filling, quality control on every batch.

Galenica Senese facility
The manufacturing process

How a sterile solution is born

From formulation to the sealed vial: every stage is validated and controlled, inside our facility in Monteroni d'Arbia.

Preparation
01

Preparation

Formulation in dedicated reactors

Aseptic filling
02

Aseptic filling

Filling lines in a clean room

Quality control
03

Quality control

Inspection and analysis on every batch

Packaging
04

Packaging

Sealed ampoules, vials and bags

Production

Guaranteed sterility, from process to batch.

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)
  • Quality system integrated with WHO, PIC/S and ICH
  • QC laboratories with HPLC and gas chromatography
  • Recognised by independent auditors as an Italian centre of excellence
Discover contract manufacturing
Third-party · CDMO

Contract manufacturing
for your company

Production capacity, regulatory know-how and experience in sterile products: from characterization of the active ingredient to the registration dossier, all the way to large-scale production.

Pilot & scale-upAnalytical developmentICH stability studiesCTD/eCTD dossier
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Research & Development

NANOSALUS project

Therapeutic nanomaterials with optimized delivery, in partnership with Ca' Foscari University of Venice. An investment of over 5 million euros in innovation.

Nanosalus project plaque — European Union, Italia Domani

Project co-financed by the European Union · Ministry of Enterprise and Made in Italy · CUP B99J23000440005

Discover the project
Healthcare professionals

Restricted area

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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Supplements line

IN-TE — wellbeing by Galenica Senese

Our line of food supplements, available in the dedicated online shop.