MoNo – the Company

190920 094832 1024x678MoNo chem-pharm Produkte GmbH was founded in 2000 as a manufacturing company and is affiliated with the long-standing business Sigmapharm Arzneimittel GmbH, which has been serving the health sector for more than seventy years. Decades of expertise, state-of-the-art production facilities and contract manufacturing at the highest level: MoNo chem-pharm Produkte GmbH sees itself as an all-round service provider and manufacturer. More about the company

Manufacturing

Mono chem-pharm Produkte GmbH specializes in the development and production of all types of pharmaceutical liquids (sterile and non-sterile, aqueous, oily, alcoholic, viscous). Our state-of-the-art facilities for the aseptic production of sterile liquid products are the lifeblood of our business. All manufacturing processes are strictly controlled and monitored in accordance with current GMP guidelines and ISO standards, enabling us to guarantee the highest quality. As a team, we at MoNo offer a comprehensive range of services for product development, clinical trial supplies, process validation and analysis. Our partnership with Sigmapharm Arzneimittel GmbH expands our range of services with regard to the compilation of submission documentation, the development of packaging design solutions as well as warehousing and dispatch logistics.

Sterile Solutions

Our production sites in Hornstein and Vienna are EU-GMP and EN ISO 13485 and EU-MDD-compliant. All manufacturing processes are vetted by the quality control department…
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Non-Sterile Solutions

MoNo chem-pharm Produkte GmbH was founded as a spin-off company of Sigmapharm Arzneimittel GmbH. Sigmapharm manufactured non-sterile products as early as 1949 and over the…
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Small Batch Service

Pharmaceuticals or medical devices are not always needed in large quantities. In fact, small batches e.g. are required for product developments and clinical samples. Following…
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Study Medication

Compliance with GMP regulations is not only a legal prerequisite for the production of study medication, but also an important safety factor for test persons,…
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Serialisation

In early 2019, the EU-wide Falsified Medicines Directive 2011/62/EU came into force. From this point onwards, prescription medicines must be provided with serialisation codes and…
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Repackaging

Repackaging Should legislation and thus the requirements concerning secondary packaging change, we are on-hand as your reliable and solution-oriented partner. At MoNo, we have over…
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Product Development

In addition to the contract manufacturing of sterile and non-sterile liquid products, our services also span the entire spectrum of product development services in this product segment. Our extensive expertise enables us to support you and collaboratively develop your new product from concept to manufacture to market launch. More about Product Development

Quality Control

190920 094832 1024x678Our highly qualified and experienced quality control team performs state-of-the-art chemical and microbiological analyses. In accordance with regulations, we check everything from the raw materials to the packaging materials to the finished product and respond flexibly to your individual needs. More about Quality Control

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