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