APIs & Fine Chemicals

Concept of science with different test tubes

APIs & Fine Chemicals

At Isha’s GMP Consultancy, we have extensive experience in setting up state-of-the-art facilities for the manufacturing of Active Pharmaceutical Ingredients (APIs), Intermediates, and Fine Chemicals.

Our Expertise Includes:

  • Facility Setup & Compliance
  • Designing and establishing API facilities in accordance with cGMP guidelines of international regulatory authorities (USFDA, EMA, WHO-GMP, etc.).
  • Revamping existing facilities to meet updated cGMP standards.
  • High-Potency API (HPAPI) Manufacturing
  • Facility design for high-potent compounds, including Oncology (Anti-Cancer), Hormones, Steroids, and Immunosuppressants.
  • Containment system design for safe handling of potent compounds.
  • Upgrading laboratories and production facilities for high-potency manufacturing.
  • Specialized Chemical Reactions & Process Design
  • Hydrogenation, including for high-potent molecules.
  • High-temperature & high-pressure reactions for complex chemical synthesis.
  • Fully automated processes ensuring precision and safety.
  • Solvent Recovery & Sustainable Practices
  •  Solvent recovery plant design to enhance cost-efficiency and environmental sustainability.

With our deep industry expertise, we provide turnkey solutions that ensure regulatory compliance, operational efficiency, and long-term sustainability in API and fine chemical manufacturing.

Turnkey Projects