Aseptic fill & finish of sterile products, from pilot batch to commercial supply
We develop and manufacture, on a contract basis, infusion and injectable solutions, dialysis solutions, human and veterinary medicines and sterile medical devices. One partner from active-ingredient characterization to the registration dossier.
Sterile parenteral specialists
Aseptic filling in cleanroom, starting from reactor-based compounding. The product ends up in a patient's vein, and we engineer every step around that.
One partner, end to end
Formulation, analytics, pilot batches, scale-up, validation, stability and dossier under one roof: fewer handoffs, less tech-transfer friction.
Manufacturing since 1949
Decades of sterile manufacturing for Italian and multinational clients, with GMP, FDA and ISO standards on every batch.
1949
In business since
198+
Catalogue references
21
Therapeutic categories
9
Container formats
What we can manufacture
A sterile platform built around parenteral solutions, for both human and veterinary use.
Infusion & injectable solutions
Sterile parenterals compounded in reactors and aseptically filled, from single-dose ampoules to large-volume bags.
Dialysis solutions
Dedicated dialysis solutions, made to parenteral-grade quality requirements.
Human & veterinary medicines
Dual human/veterinary GMP authorization: we serve both worlds to the same sterile standard.
Sterile medical devices
Sterile solutions in plastic containers classified as medical devices.
Multiple formats & volumes
From single-dose ampoules to large-volume bags and jerricans, adapting the same solution to different uses and markets.
Full in-house quality control
In-house chemical and microbiological labs with HPLC and gas chromatography: release does not depend on third parties.
The journey, from feasibility to supply
A structured path that takes your product from raw material to industrial scale, with regulatory work built in throughout.
- 1
Active-ingredient characterization
Study and qualification of the active ingredient and its compatibility with process and container.
- 2
Analytical development & methods
Development of analytical methods and their validation to applicable standards.
- 3
Pilot batches
Pilot batches to fine-tune the formulation and process parameters.
- 4
Scale-up & industrialization
Reproducible transfer of the process from pilot to industrial scale.
- 5
Validation & ICH stability
Process and method validation, plus ICH-compliant stability studies.
- 6
CTD/eCTD registration dossier
Preparation and support of the dossier in CTD/eCTD format, including in foreign languages.
- 7
Manufacturing & batch release
Commercial-scale aseptic manufacturing with quality control and batch release.
Manufacturing capabilities at a glance
The sheet a sourcing manager scans first to assess fit. Quantitative parameters (volume ranges, batch sizes, line capacity) are shared under NDA during feasibility.
- Dosage forms
- Sterile parenteral solutions for human and veterinary use, in different formats and volumes.
- Filling technology
- Aseptic filling in cleanroom, starting from reactor compounding.
- Container formats
- Plastic bags and dual-chamber bags, glass and PP bottles, ampoules, vials, cartridges, prefilled syringes, jerricans.
- Batch size
- From pilot batch to industrial scale, with campaign flexibility (numeric ranges under NDA).
- Fields of use
- Human medicines, veterinary medicines, dialysis solutions, sterile medical devices. Over 198 catalogue references across multiple therapeutic categories.
- Quality control
- In-house chemical and microbiological labs with HPLC and GC; analytical method development and validation.
- Regulatory framework
- GMP (human and veterinary), WHO, PIC/S, ICH standards; FDA Approved; ISO 9001, 14001, 13485, OHSAS 18001.
- Regulatory support
- CTD/eCTD dossier preparation, including in foreign languages; ICH stability studies built into the path.
Containers & formats
A broad range of sterile glass and plastic containers, to match the packaging to your product and your market.
Plastic bags
For large-volume infusion solutions.
Dual-chamber bags
Two compartments keeping components separate until the moment of use.
Glass bottles
For injectable and infusion solutions.
PP plastic bottles
Unbreakable polypropylene, ideal for devices and large volumes.
Glass ampoules
Sealed single-dose units for small-volume injectables.
Vials
For small- and medium-volume injectable solutions.
Cartridges
For dedicated delivery systems.
Prefilled syringes
Ready to use, reducing administration steps.
Jerricans
For high volumes and technical applications.
Quality & regulatory framework
Every batch is made within a certified quality system, designed to withstand the audits of your markets.
GMP for human & veterinary use
Site authorized for GMP manufacturing of both human and veterinary medicines.
International standards
We operate to WHO and PIC/S standards and ICH guidelines.
FDA Approved
FDA Approved site.
ISO certifications
ISO 9001 (quality), ISO 14001 (environment), ISO 13485 (medical devices) and OHSAS 18001 (occupational health & safety).
In-house quality control
Chemical and microbiological labs with HPLC and gas chromatography for testing and release.
R&D & academic research
Research & Development laboratory and collaboration with the University of Siena.
Why Galenica Senese
A sterile manufacturer rooted in the Siena area, with a mature quality system and a complete CDMO service.
Active since 1949
A long, continuous industrial history in sterile manufacturing.
Multi-format
Ampoules, bottles, vials, bags, cartridges, prefilled syringes and jerricans: a single partner for different formats.
End-to-end service
From active-ingredient characterization to the registration dossier, under one roof.
Human & veterinary
Dual GMP authorization to serve both sectors.
In-house quality control
Own chemical and microbiological labs: release independent of third parties.
Part of the industrial system
Members of Farmindustria and Confindustria Siena.
How we work together
A simple, confidential engagement designed to reduce risk before committing volumes.
- 01
First contact & NDA
You tell us about the molecule, the format and the target market. We sign a non-disclosure agreement before any technical data is exchanged.
- 02
Feasibility & quotation
We assess compatibility with our lines and containers and give you a realistic path and quotation.
- 03
Development & tech transfer
We transfer the process with gap analysis, analytical methods and pilot batches; the marketing authorization and dossier remain yours.
- 04
Industrialization & supply
Scale-up, validation, stability and commercial production with quality control and batch release.
Frequently asked questions
Answers to the questions we are most often asked by those evaluating a partner for their sterile products.
Can we transfer our existing formulation?
Yes. The starting point is a structured technology transfer: NDA, a gap analysis of your process and specifications, then transfer and validation batches. Where the formulation is already established we reproduce it on our lines; if compatibility constraints emerge with lines or containers, our R&D lab proposes the minimum necessary adjustments, always agreed with you.
Who owns the marketing authorization and the dossier?
They remain yours. In contract manufacturing the marketing-authorization holder (MAH) and owner of the registration dossier is you (or your principal); we appear as the manufacturing and/or testing site. We provide the CMC documentation (Module 3) that falls to us, but ownership and product know-how stay entirely with you.
Do you run pilot batches before industrial production?
Yes. The typical path runs through active-ingredient characterization, pilot batches to fine-tune the process, then scale-up and validation batches before routine industrial production. This phased approach reduces risk before committing full volumes and investment.
Which sterile formats and containers do you handle?
Aseptic filling of injectable and infusion solutions in plastic bags, dual-chamber bags, glass and plastic (PP) bottles, ampoules, vials, prefilled syringes and cartridges. During feasibility we verify together the format and volume best suited to your product and your market.
Do you support the dossier for foreign markets?
Yes. We prepare and update the documentation in CTD/eCTD format, including in foreign languages, and support the registration process and post-approval variations. The site operates under GMP integrated with international standards (WHO, PIC/S, ICH), so the same documentation base can serve multiple markets.
What certifications do you hold, and do you accept client audits?
We operate under GMP for human and veterinary use, with ISO 9001, 14001 and 13485 certifications and FDA recognition. We are subject to periodic inspections by the competent authorities and we welcome the client's quality audits, both before signing and during the collaboration.
How do you handle confidentiality and intellectual property?
We sign a non-disclosure agreement (NDA) before any exchange of technical data. Your formulation, analytical data and know-how remain your property; we apply information segregation and internal rules to avoid conflicts between clients.
Do you only make human medicines?
No. The same site operates under GMP for both human and veterinary medicines and produces sterile plastic medical devices. This makes it possible to manage mixed portfolios with a single qualified partner.
Let's talk about your product
Tell us about your molecule and your target: we'll assess feasibility and the path together, including under NDA.
Confidentiality guaranteed: we sign the NDA before any data exchange.