Manufacturing Production

Production Capabilities

Coupled with the synthesis of process intermediates and GMP raw materials, we also offer cGMP manufacturing of your API in small scale and in production scale. Ami Lifesciences handles small-scale API production critical for discovery and development, GMP scale and manufacturing at our facility. We handle your cGMP manufacturing needs seamlessly from grams to metric tons - and through all phases of clinical trials - without the need for technology transfer to another company. Whether you require the preparation of API for toxicological studies, Phase I-III clinical trials or commercial supplies, we leverage the expertise and technology to make your project a success.

Ami Lifesciences has the infrastructure to perform scale-up. Our kilo-scale laboratories are equipped for the preparation of cGMP starting materials and other process intermediates on a scale from hundreds of grams to tens of kilograms.

Our capabilities include:

  • 10 production blocks with 11 clean room area covering 1500 metric tons of production capacity.
  • 136 reactors and total reactor volume of around 650 KL.
  • 100 litres to 16MT glass lined and SS reactors with fully integrated manufacturing plant
  • Capability of handling high pressure and complex organic reactions
  • Facility have been inspected by EDQM, Cofepris (Mexico).
  • The site is under USFDA approval.
  • Site is also WHO GMP approved and ISO 9001:2000 certified.
  • The flow of materials and personnel through the facility is designed to prevent mix-ups or contamination.

Regardless of scale or complexity, we have the expertise, capacity, and capabilities to rapidly meet custom synthesis needs. From milligram quantities of a metabolite to several kilograms of a scaffold, we tailor our services to suit the needs, applying a chemical or bio catalysis approaches depending on the complexity of your molecule. For the quickest turnaround, including the synthesis of reference standards, impurity markers and scaffolds, we offer a rapid scale-up facility. Our world-class facilities are equipped with the latest in process and analytical instrumentation and offer cost-competitive solutions for project.

QC Lab Instrument Details:

For Quality Control, we have various equipment as follows:

  • Chromatography: HPLC, UPLC, GC, GC Headspace
  • Spectroscopy: FT-IR, UV-Vis, ICP-MS, Microwave digestion
  • Particle Size Distribution: Malvern Mastersizer, Microscopy, Bulk Density and Tap Density Tester
  • Wet chemistry and Pharmacopeial analysis: Cooling Cabinet, Karl Fischer Titrator, Auto Titrator, pH Meter, Turbidity Meter, Halogen Moisture, Melting Point Analyser, Colony Counter, Autoclave, Incubator, Fogger Machine, Anaerobic Culture Jar, Bio-safety Cabinet, Conductivity Analyser, Air Sampler
  • Other Systems:

    Mass Detector, Polarimeter, Muffle Furnace, Milli-Q Water Purification, Vacuum Oven, LOD Oven, Glassware Oven, Conductivity and TDS Meter, Ultrasonic Bath, Stability Chambers, Air Sampler