Our modern multipurpose and FDA inspected facility in Vizag also has a dedicated High Potent API manufacturing facility. It can support products that range from early phase development to commercial launch and manufacturing.
The following are further details on the HPAPI capability:
- Containment systems (isolators) to handle compounds with an OEL up to 0.1µg/mᶟ/8h shift. Isolators at dispensing, processing and testing locations
- HPAPI capacity that can produce products ranging from 0.5Kg to 50Kg
- Equipped with containment technology, controls and capabilities for safe handling of highly-potent APIs
- Separate QC lab for testing
- An independent storage facility for intermediates/HPAPI
- Several products have been successfully validated and supplied