Beyond The Science
Production system in compliance
with Global GMP requirements
  • 01 compliance with GMP process from warehousing to release of API
  • 02 compliance with KGMP, EuGMP, cGMP requirements
Small API ServiceSmall scale synthesis
  • Route scouting
  • Feasibility studies
  • Synthesis of compounds in mg/g scale
  • Metabolite synthesis
  • Preparation of standards / reference substances
  • Impurity profiling
  • Impurity reference synthesis
  • Synthesis of stable isotope labelled substances
Contract manufacturing and analytical services
  • cGMP manufacturing of APIs and key intermediates
  • Analytical method validation
  • Process validation
  • Full CMC package
  • Drug master files: compilation, maintenance
  • Comprehensive documentation
API process development & scale-up
  • Design of experiments (DoE)
  • Chemical process development
  • Process scale up
  • Process optimization
  • Analytical method development
Smart Automation System
  • - Reactor, Extractor, precipitation reactor (operation, temperature/vacuum etc.)
  • - HVAC and Utility
  • - Temperature/humidity and room differential pressure of Production building, laboratory
Data Management
  • - Data collection and management with data integrity
GMP Pilot Manufacturing
  • 2 independent production units
  • Reactor volume from 50 to 200 L
  • Operation temperature: -30 °C – +180 °C
  • 74L vacuum dryer
  • 172L Dryer
  • Line 1
  • Line 2
  • Agilent HPLC systems with UV detectors
  • GC systems with FID detector and automatic liquid/Head-Space sampler
  • FT-IR spectrometer with diamond ATR accessory
  • Karl Fischer titrator
  • UV-spectrophotometer
  • High sensitivity polarimeter
  • Melting point apparatus
  • Stability study chambers
  • TOC Analyzer
  • pH meter
  • Conductivity meter
Manufacturing Equipment
Equipment Name Model No. Material
50L Reactor RE-102 Hastelloy
200L Reactor RE-202 Hastelloy
50L Crystallizer CR-101 Hastelloy
200L Crystallizer CR-201 Hastelloy
50L Extractor RE-101 Hastelloy
200L Extractor RE-201 Hastelloy
Nutsche Filter(10L) NF-101 SUS316
Nutsche Filter(10L) NF-102 SUS316
Nutsche Filter(70L) NF-201 SUS316
Nutsche Filter(70L) NF-202 SUS316