Infrastructure
Production Capabilities
As a leading API manufacturer and Contract Development and Manufacturing Organization (CDMO) partnering both domestically in India and internationally, we specialize in API manufacturing through complete backward integration. Our extensive suite of services includes API development and Commercial Manufacturing for Innovators and Formulators. We effortlessly scale from grams to multi-tonnage, adhering strictly to cGMP norms.
Our notable capabilities encompass:
– Site approved for GMP and certified with ISO 9001:2000, with WHO-GMP certification underway.
– Our manufacturing facility stands as a Zero Liquid Discharge (ZLD) site, featuring a cutting-edge 100 KLD Multi Effect Evaporation System (MEE).
– Four production blocks, housing pristine clean room areas, collectively facilitating a substantial 900 metric tons of production capacity.
– A remarkable array of 45 reactors, boasting a combined reactor volume reaching approximately 150,000 Litres.
– Versatile reactor options ranging from 100 litres to 10KL, including Hastelloy, Glass lined, Halar coated, and SS reactors. These seamlessly integrate into our manufacturing setup.
– Proficiency in handling high-pressure conditions and orchestrating complex organic reactions.
– Our facility is meticulously designed to ensure the unimpeded flow of materials and personnel, assuring the prevention of mix-ups or contamination.
Irrespective of scale or intricacy, our prowess, capacity, and competencies enable us to promptly meet custom synthesis requirements. We adapt our services to suit specific needs, leveraging chemical or bio catalysis approaches based on your molecule’s complexity. For expedited results, encompassing reference standards synthesis, impurity markers, and scaffolds, our swift scale-up facility stands at your disposal.
Our state-of-the-art facilities house cutting-edge process and analytical instrumentation, delivering cost-competitive solutions across diverse projects.
Quality Control Laboratory Equipment Overview:
Chromatography:
– High Performance Liquid Chromatography (HPLC)
– Ultra-Performance Liquid Chromatography (UPLC)
– Gas Chromatography (GC) – GC Headspace
Spectroscopy:
– Fourier-Transform Infrared Spectroscopy (FT-IR)
– UV-Visible Spectrophotometry (UV-Vis)
– Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
– Microwave Digestion
Particle Size Analysis:
– 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 Analyzer
– Melting Point Analyzer
– Colony Counter
– Autoclave
– Incubator
– Fogger Machine
– Anaerobic Culture Jar
– Bio-safety Cabinet
– Conductivity Analyzer
– Air Sampler
Other Systems:
– Mass Detector
– Polarimeter
– Muffle Furnace
– Milli-Q Water Purification System
– Vacuum Oven
– Loss on Drying (LOD) Oven
– Glassware Oven
– Conductivity and Total Dissolved Solids (TDS) Meter
– Ultrasonic Bath
– Stability Chambers
– Air Sampler
Reactions Conducted On-Site:
A wide range of chemical reactions is performed at our facility, including but not limited to:
– Chlorination
– Bromination
– Hydrogenation
– Epoxidation
– Hydrolysis
– Reduction
– Condensation
– Methylation
– Friedel Craft Reactions
– Grignard Reactions
– Suzuki Coupling
Temperature Range: -40°C to +250°C
Clean Rooms
– Our site features 7 dedicated air handling units (AHUs) for different areas, each equipped with pre-filters, HEPA filters, and validated AHU systems.
– No air re-circulation is employed.
– The classified area adheres to Class 1,00,000 standards.
Quality Management System
– Our Quality Management System aligns with ICH guidelines.
– Changes are meticulously managed through a robust change control procedure.
– Deviation procedure is firmly in place.
– Annual product quality reviews are conducted.
– Batch release procedure ensures stringent quality checks.
– Vendor qualification procedure is implemented.
– Procedures for handling market complaints, as well as corrective and preventive actions, are established.