Sai - Make it better togther

Contact a Representative

Contact us to discuss your requirements

US: Eric Neuffer: +1 908 850 3460
Europe: Dirk Sartor, PhD: +49 152 3361 4996
Asia Pacific: K. Karthik +91 (0)998 930 2255
Global: Marcel Velterop: +41 (0)797 733 453

Email: info@sailife.com

Alternatively, fill out the form below

Sai has an FDA & PMDA approved manufacturing facility and a cGMP intermediate facility dedicated for Contract Manufacture activities. The units can support the manufacture of clinical trial materials and commercial products from a few kilograms, through multi-ton level, up to some 30 ton per product and annum. From January 2017 onwards the total installed reactor capacity will be 240 cubic meters consisting of glass-lined and stainless-steel reactors ranging in size from 50L to 8KL.

The plant setup is highly flexible and can support a range of complex reactions with temperature from -80˚C to 250˚C as well as large-scale hydrogenation up to 4KL. The plant has capabilities to handle cyanation, birch reduction, most reduction

chemistries involving pyrophoric reagents and other difficult to handle chemistries. The manufacturing engineers and technology transfer teams work closely with PR&D to ensure scale-up of new processes into the plant.  Each plant is equipped with a satellite Process Development lab to ensure there are constant improvements in the synthetic process as the products move through the various phases.

Our QA/QC teams can provide comprehensive regulatory support and have successfully overseen four FDA, one PMDA audit and supported over ninety client-led cGMP audits in the last three years.

Unit II – ICICI Knowledge Park, Hyderabad

  • 6 Synthetic labs with 42 workstations
  • 1 Cytotoxic kilo suite up to 0.1mcg/m3
  • 6 Non GMP kilo suites
  • 4 cGMP Kilo suites with high potency (1-10 mcg/m3) handling capability
  • Class 100,000 clean rooms capable of handling high potency (1-10 mcg/m3) compounds
  • Analytical lab equipped with HPLC / UPLC / GC / GC HS / GCMS
  • Risk Assessment lab with calorimetry and Thermal Screening Unit
  • CEM Microwave reactor

Unit III – IDA Bollaram, Hyderabad

  • 40KL of combined reactor volumes with high flexibility
  • cGMP RSM & intermediate manufacture
  • Scale up facility with dedicated technology absorption team
  • 2 cGMP kilo Lab Suites
  • Reactors ranging from 100L – 3000L
  • Cryogenic reaction capability (-70˚C) and high temperatures up to 200˚C
  • Hydrogenators from 20L to 1000L to handle pressures as high as 50kg/cm2
  • High vacuum distillations up to 0.2 torr
  • Solvent recovery systems
  • ICH stability chamber

Unit IV – Bidar, Karnataka

  • FDA inspected site for GMP manufacturing to support pre-clinical and clinical trials (cGMP contract manufacturing)
  • 6 Manufacturing blocks with around 110KL of combined volume
  • Reactors ranging from 250L to 80KL
  • Upcoming large volume block with 3-8KL reactors adding 93KL volume by early 2017 creating a total volume of 205KL
  • 4 clean rooms (Class 100,000) with 70L, 500L and 2000L crystallizers
  • 3 Hastelloy reactors of 250L, 500L and 1.5KL sizes
  • Commercial scale chromatography block with 300mm Dia Novasep column and multi-purpose gradient feed skids
  • Hydrogenators to handle pressures up to 10bar
  • Temperature range: -80˚ to 250˚C
  • Zero discharge facility with biological treatment, multiple-effect evaporators and reverse osmosis systems