CMO

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Enaltec offers technology transfer and manufacturing by co-development of manufacturing process of advanced intermediate and drug substance. API / material can be manufactured in large quantities required for clinical trials, formulation trials, launch of new drug products, etc.

Our manufacturing site has been approved by US FDA and WHO; manufacturing is done as per GMP guidelines under strict regulatory compliance.

Services Offered:

  • Manufacturing for pre-clinical and clinical supplies

  • Analytical method transfers and validation

  • Scale up, process validation and stability studies

  • Technology transfer and manufacturing

  • Vendor identification and vendor development for key raw materials

Site Capabilities:

  • Pilot scale reactors ranging 500L – 2000 L (stainless steel / glass-lined)

  • Hydrogenation facility

  • Kilo lab / Scale up facility 50L – 100 L Glass assemblies

  • Drying, milling, micronisation and packaging facility

  • Well-equipped, state of the art QC laboratories

Salient Features:

  • State of art lab services and production pilot plants

  • Manufacture of low volume “niche” APIs

  • US FDA and WHO Approved manufacturing facility

  • Drying, milling, micronisation and packaging facility

  • Onsite Quality Assurance and Regulatory Affairs support