Custom Synthesis and API Manufacturing
Midas offers development and/or manufacturing of early or advanced intermediates and active pharmaceutical ingredients. We can deliver one or all building blocks along your synthetic pathway including biocatalytic steps up to the final API. All compounds can be tailored to meet your particular requirements, with target compound synthesis based on a predefined process or ‘from scratch’.
Scope of Service Offering
We provide services for:
- High-potency APIs (HAPIs)
- Early and late stage/advanced intermediates (IMs).
We are able to provide a complete solution during the entire molecule lifecycle — from the pre-clinical stage up to the market (non-GMP and GMP). Our services are offered as a complete package or on a modular basis.
Our services include:
- Process development and optimization for APIs and IMs
- Process validation
- Development and validation of analytical methods
- Synthesis of impurities, reference standards, etc.
- Salt screening, co-crystal screening, polymorphism studies
- Stability studies according to ICH guidelines
- Sourcing of raw materials or IMs
- Production and supply of APIs and IMs
- Technical transfer to another manufacturer/manufacturing site (if requested).
We offer our services on an exclusive basis and all information is treated strictly confidential. In working with our customers and partners, we believe in full transparency and open communication. You are directly involved in discussions with our partners and are always fully aware of the activities and progress. You will gain access to our integrated, global network of partners and pool of special technologies, as well as the knowledge gained from our years of experience and that of our industry-leading partners.
The specialist teams at Midas cover all stages of the pharmaceutical value chain and are able to provide complete solutions to meet the specific needs of each customer.
As well as custom synthesis and API manufacturing, we offer a range of complementary services.
Quality Management Services — qualification of raw material and/or IM sources including audit reports. More
Regulatory Affairs Services — ASMF/CEP filing, communication with regulatory authorities. More
Intellectual Property Services — patent landscape evaluation, product clearance, freedom-to-operate analysis and development support, generation and protection of novel IP. More
Biotech Services — biocatalytic services for process optimization of APIs and IMS. More