CMO

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 product 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 transfer 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 500 – 2000 L (stainless steel / glass-lined)
  • Hydrogenation facility
  • Kilo lab / Scale up facility 50 – 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