Contract Manufacturing of Intermediates and Drug Substances

With our global network of qualified manufacturing partners, Midas Pharma provides comprehensive CMO services for Intermediates and APIs. As a leading service provider in the pharmaceutical industry, our goal is to turn your ideas into success. We are committed to delivering the best tailored solution for your project and specific requirements.

Full customized end-to-end services

We offer syntheses of advanced Intermediates and Active Pharmaceutical Ingredients (APIs) on an exclusive basis through a global network of qualified CMO partners, ensuring full cGMP compliance and adherence to the latest regulatory requirements and highest quality standards.

Non-GMP capabilities & expertise for the manufacture of early stage intermediates and building blocks are also part of our service portfolio. We continuously provide services to our customers ranging from small start-ups to globally established corporations.

Through our extensive global network of trusted and qualified CMO and CRO partners, we have no limitations in terms of chemistry, technology, or production volumes, ranging from grams to tons.

Highly committed Midas project managers with scientific & expert backgrounds, will evaluate, manage and execute the project in accordance with your expectations.  

In addition to manufacturing and supply, we cover complementary services which are required to make your project a success: intellectual property, quality management, regulatory affairs, logistics (import, export, CLP, REACh) etc.

We look forward to your inquiry!

Contract Manufacturing of Intermediates and Drug Substances

CMO Services for Intermediates and APIs:

  • Process: transfer/Up-Scaling/optimization (lab – pilot – plant) as requested
  • Analytical methods: transfer/development/validation/verification as needed
  • Process validation
  • Stability studies according to ICH guidelines
  • Documentation ready for regulatory filing (CEP/ASMF/USDMF…)
  • Commercial supply
  • Synthesis and supply of impurities, reference standards, etc. as requested

Additional services:

  • Sourcing of raw materials/intermediates
  • Supplier evaluation, qualification (incl. audits)
  • Logistics - import, export, distribution, REACh
  • Supply Chain Management
  • FDF development & manufacture on exclusive basis

Your Contact

Dr.  Gordana Gadanji

Dr. Gordana Gadanji

Custom Synthesis & Technology transfer
Director

Midas Pharma GmbH
Rheinstr. 49
55218 Ingelheim
Germany
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Midas Pharma test tubes

Chemicals and Intermediates

Midas offers a broad range of intermediates including industrial reactives, fine chemicals as well as critical and advanced intermediates.

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