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