Macsen Labs has been manufacturing Active Pharmaceutical Ingredients since 1952.
We manufacture niche and rare to find API molecules. We specialize in manufacturing injectable pharmaceutical dyes and are the only manufacturer in the world having a complete range of pharmaceutical application dyes. Our API manufacturing is done in compliance with cGMP as per guidelines of WHO, ICH & FDA. We have state of art facilities with fully qualified equipment and validated utilities. The final stages of manufacturing are done in classified clean rooms. We have a very strong team for Quality Assurance, Regulatory Compliance and Quality Control. Our top management includes technocrats and scientists who are deeply involved technically in this business. We have a state of the art R&D setup with a highly qualified team and latest equipment like LC-MS/MS, GC-MS/MS, etc, which gives us the ability to synthesize complex organic molecules in a short timeframe. We have a dedicated team for technology transfer of process from R&D to Pilot Scale and from Pilot scale to Plant scale. Our Grams to Tons production capacity can cater to new drug innovators from clinical studies till launch of the drug.
State of the art R & D Set up
US FDA Registered
WHO GMP certified
EU Written Confirmations from CDSCO
Complete documentation support like DMF, Tech Pack, Process Validations, Analytical Method Validations, Stability Studies, Degradation Studies, Drug Characterization, etc.
Can manufacture in batch sizes ranging from grams to Kgs in reactor volumes of 5-5000 ltrs.
Open for facility audits by customer and international regulatory bodies