We empower innovation through cutting-edge technology while ensuring strict compliance with regulatory standards
Our state-of-the-art GMP-compliant manufacturing facility covers a 7000-square-foot footprint and has four floors with separate areas for intermediate and API production. The facility is meticulously designed to ensure the highest standards of manufacturing and meet the regulatory standards of the US, Japan and the EU.
Equipment
Stainless Steel and Glass Lined Reactors ranging from 1kL to 10kL capacity
Temperature Handling Range
40° C to 130° C
High Pressure Handling Capacity
Upto 20 bar
High Vacuum Handling Capacity
Upto 0.001 bar
Key Features of the Facility
Facility designed for multiple product manufacturing
Class 100,000(ISO 8) cleanroom modules with 0.3 micron terminal HEPA filters
Contained Powder Transfer Systems for all powder transfers
Separate entries for man and material
Airlocks at all entry areas
Online metal detection system for final product
Two-pass RO system and Electro-Deionizer for purified water generation ensuring strict adherence to USP and EP
Closed ambient loop systems for both purified and potable water
DCS system for critical process controls
Exclusion of penicillins, cephalosporin, steroids, cytotoxics, and agrochemicals’ products development or production at the site