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Our technical manufacturing capabilities span a wide range of reactors with high flexibility in size (1,000-2,000 gal, 1,000-2,600 gal, 140 gal, 0.2 to 1 Lt.), multiple product isolation technologies (centrifuge, filters) with wide material compatibility (Hastelloy; stainless steel), multiple drying options (agitated and static dryers) and multiple powder handling and finishing capabilities including sieving, blending and milling.
As our Plant has many different production buildings, we can offer a manufacturing flexibility not common or easy to find in the API manufacturing market.
Strengths of our small-scale manufacturing platform include pilot scale API manufacturing up to 10 kg.
We also offer Kilo Lab Technology Transfer services for chemically synthesized drug substances and drug products. We provide our clients all the assessment for the technology transfer process and the FDA procedures and necessary documents for the assurance of consistency through development and manufacturing.
Our solvent recovery farm counts on a steam stripper, five storage tanks and three recuperation columns.
Our highly skilled employees aim to deliver accurate and timely test results with industry leading laboratory equipment, information technology solutions and the best customer service and quality to ensure regulatory compliance.
Our complex counts on a Quality Assurance building, with more than 10,500 ft2 of analytical labs, process development and environmental labs.
Our laboratories are equipped with stability chambers (walk-in chambers and vertical chambers) that allow us to determine the period of time and storage conditions under which raw materials, preparations and medicines are kept within the required specifications of identity, power, quality and purity.
We can carry out studies of accelerated, real time and long term stability among others and all the laboratory testing that these studies require as well as the documentary record required by the different regulatory entities.