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LMS has two world class manufacturing sites with state-of-the-art facilities and multi-product capabilities
Lupin Manufacturing Solutions Limited (LMS) has both the scale and the wide range of operations to manufacture intermediate and active pharmaceutical ingredients which enable affordable and high-quality drug substance across various therapeutic areas from its two manufacturing facilities at Dabhasa, Gujarat and Vishakhapatnam, Andhra Pradesh.
Scale Up Capabilities
Over 200 individual reactors totaling 700m3 of capacity with a range of materials of construction, temperature and pressure operating windows provide both scale and capability for most synthetic manufacturing steps including hydrogenation with accompanying solids separation, purification, drying and finishing assets. The separation capability includes pressure filtration, nano filtration, chromatographic separation, rotary and wiped film evaporation. The drying capability includes pressure filter, agitated thin film, vacuum and lyophilization. A dedicated Highly Potent Active Pharmaceutical Ingredient (HPAPI) facility services the needs for safe and compliant manufacture of such entities including antibody drug conjugate (ADC) linker payloads.
The infrastructure at sites provides all required utilities for cost-effective, high occupancy operation including on-site solvent recovery systems and zero-liquid discharge effluent treatment.
Quality Control
All operations are undertaken under a robust Quality Management System efficiently supported by a range of individual and compliant operating systems.
Quality Control is executed with a full range of instrumentation including HPLC, GC, Head space GC, FTIR, UV, AAS, XRD, Particle Size Analyzer, LCMS, GCMS, ICPMS. An in-house Microbiology Laboratory ensures prompt analysis of product, water and environmental monitoring.
Dedicated, on-site warehouses with Cold Rooms (2-8°C)and Control Temperature rooms (below 25°C) address the full range of storage temperature requirements for raw materials, intermediates and finished goods
Regulatory Expertise
The facilities have an excellent track record with regulatory authorities including US Food and Drug Administration (FDA), and most recent inspections in March 2023 and April 2024, both generating zero observations. Further successful inspections include Brazilian Health Regulatory Agency (Anvisa) in December 2022 and Australian Regulatory Agency (TGA) in October 2024.
Manufacturing Sites
State-of-the-art facilities with multi-product capabilities
Visakhapatnam
