Contract manufacturing of pharmaceutical liquids: sterile and non-sterile solutions, small batches, study medication, packaging and analytics
MoNo chem-pharm Produkte GmbH
1200 Vienna (Leystraße 129) · 7053 Hornstein (Mondpichlerplatz 1) · 7052 Müllendorf (warehouse)New on Amplifa
About MoNo chem-pharm
MoNo chem-pharm Produkte GmbH was founded in 2000 as a spin-off of the production operations of Sigmapharm Arzneimittel GmbH, established in Vienna in 1949, and is an independent Austrian contract manufacturer and service provider for pharmaceutical liquids. The company specializes in the development and production of all types of liquid pharmaceutical products – sterile and non-sterile, aqueous, oily, alcoholic and viscous, including in the dosage forms drops, spray and vial. Its core capability is facilities for the aseptic production of sterile liquid products; in addition, non-sterile solutions, herbal and homeopathic medicinal products, small and very small batches as well as clinical trial supplies (Phase I–IV) are manufactured. The range of services covers product development, formulation, pilot batch production, process validation, quality control, batch release by the Qualified Person, serialization, repackaging, stability testing as well as regulatory affairs management and pharmacovigilance in cooperation with Sigmapharm Arzneimittel GmbH. Production takes place at the GMP-certified sites in Vienna (Leystraße 129, head office and batch release) and Hornstein (since 2019), complemented by a warehouse in Müllendorf.
- Site
- Vienna
- Processes
- Aseptic manufacturing of sterile liquid products, Manufacturing of non-sterile liquid medicinal products, Small batch service (GMP-compliant filling area cleanroom class A/B for small and very small, Study medication (manufacture of clinical trial supplies Phase I-IV), Serialization, Repackaging / primary and secondary packaging (incl. hard and soft gelatin capsules), Product development (formulation, pilot batch production, process validation, scale-up), Analytics / quality control (HPLC, UV-VIS, FTIR, rheology, refractometer, tensiometer)
- Materials
- Anti-fog agents for medical optics (medical device in liquid form), ENT solutions (medical device in liquid form), Inhalation products (medical device in liquid form), Eye drops (medical device in liquid form), Sterile pharmaceutical liquids (aseptically manufactured), Non-sterile liquids, Medical devices in liquid form, Herbal and homeopathic medicinal products
- Certificates
- EU-GMP (manufacturing authorization), GMP certificate Vienna Leystraße, GMP certificate Hornstein, EN ISO 13485:2016, ISO 13485 (MDSAP), MDR QM certificate (Annex IX), ISO 9001
- Founded
- 2000
- Industries
- Pharmaceutical industry, Medical devices, Dietary supplements
- 01
Raw material selection and supply chain management
- 02
Product development and formulation
- 03
Pilot batch production and process validation
- 04
Manufacturing (aseptic sterile / non-sterile)
- 05
Quality control and analytics
- 06
Batch release by Qualified Person
- 07
Primary and secondary packaging, serialization
- 08
Warehousing and shipping logistics
Product Groups and Processes
Sterile pharmaceutical liquids (aseptically manufactured)
Small-volume liquid dosage forms, aqueous, oily, alcoholic or viscous, including eye drops and inhalation products.
Non-sterile liquids
Liquid dosage forms for external and internal use, including ENT solutions.
Medical devices in liquid form
Anti-fog agents for medical optics, ENT solutions, inhalation products and eye drops (risk class IIa).
Herbal and homeopathic medicinal products
Manufacture in accordance with the approved scope of the manufacturing authorizations for Vienna and Hornstein.
Hard and soft gelatin capsules
Primary and secondary packaging as part of the packaging activities.
Clinical trial supplies (Phase I–IV)
Study medication as authorized manufacturer of investigational medicinal products.
Sites
Vienna
ATProduction site, batch release, head office
- Lot size
- Small, very small and medium batches
- Materials
- Sterile and non-sterile liquids, herbal/homeopathic medicinal products
- Facilities for aseptic production of sterile liquid products
- GMP-compliant filling area cleanroom class A/B for small and very small batches
- HPLC
- UV-VIS spectrometer
- FTIR spectrometer
- Rheometer
- Refractometer
- Tensiometer
Hornstein
ATProduction site, branch office
- Lot size
- Small to medium batches
- Materials
- Sterile and non-sterile liquids
- Facilities for aseptic production of sterile liquid products
Müllendorf
ATWarehouse
Product and Service Profiles
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Aseptic manufacturing of sterile liquid productsPharmaceutical manufacturing | – | – | – | – | pharmaceutical liquids (aqueous, oily, alcoholic, viscous) |
| Manufacturing of non-sterile liquid medicinal productsPharmaceutical manufacturing | – | – | – | – | liquid dosage forms for external and internal use |
| Small batch service (GMP-compliant filling area cleanroom class A/B for small and very smallPharmaceutical manufacturing | – | – | – | small and very small batches – medium batch sizes | medicinal products, medical devices, dietary supplements |
| Study medication (manufacture of clinical trial supplies Phase I-IV)Pharmaceutical manufacturing | – | – | – | – | – |
| SerializationAssembly | – | – | – | – | – |
| Repackaging / primary and secondary packaging (incl. hard and soft gelatin capsules)Assembly | – | – | – | – | hard gelatin capsules, soft gelatin capsules, liquid dosage forms |
| Product development (formulation, pilot batch production, process validation, scale-up)Engineering | – | – | – | – | liquids in dosage forms drops, spray, vial |
| Analytics / quality control (HPLC, UV-VIS, FTIR, rheology, refractometer, tensiometer)Testing | – | – | – | – | raw materials, packaging materials, bulk solution, finished product |
| Batch release by Qualified Person (QP)Testing | – | – | – | – | – |
| Manufacturing of herbal and homeopathic medicinal productsPharmaceutical manufacturing | – | – | – | – | herbal medicinal products, homeopathic medicinal products |
| Microbiological testing of non-sterile products (bioburden, environmental monitoring)Testing | – | – | – | – | – |
8 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Facilities for aseptic production of sterile liquid products | – | – | – | – | Vienna (Leystraße) / Hornstein |
| GMP-compliant filling area cleanroom class A/B for small and very small batches | – | – | – | – | – |
| HPLC (instrumental analytics) | – | – | – | – | – |
| UV-VIS spectrometer | – | – | – | – | – |
| FTIR spectrometer | – | – | – | – | – |
| Rheometer | – | – | – | – | – |
| Refractometer | – | – | – | – | – |
| Tensiometer | – | – | – | – | – |
Additional services
Reference customers
Quality and Certification
A process-oriented quality assurance system monitors all manufacturing processes; quality control tests raw materials, packaging materials, bulk solution and finished product using instrumental analytics (HPLC, UV-VIS, FTIR, rheology, refractometer, tensiometer) and wet chemistry. Batch releases are performed by the Qualified Person (QP) at the Vienna Leystraße site.
| Evidence | Vienna | Hornstein | Müllendorf |
|---|---|---|---|
| EU-GMP (manufacturing authorization) | |||
| EN ISO 13485:2016 | |||
| ISO 13485 (MDSAP) | |||
| MDR QM certificate (Annex IX) | |||
| ISO 9001 |
Company History
- 1949
Founding of Sigmapharm by Prof. Dr. Herbert Pichler and Dr. Herbert Punzengruber in Vienna
- 2000
Spin-off of Sigmapharm's production operations into MoNo chem-pharm Produkte GmbH
- 2019
Opening of the second production site in Hornstein