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Incorporated in 1986, Embio Limited, a leading global player in the domain of controlled substances and chiral molecules manufactured through bio-transformation. We are one of the largest, totally integrated manufacturer in the world of Active Pharmaceutical Ingredients, Ephedrine, Pseudoephedrine and advanced intermediates of Norephedrine Isomers. This leadership position has been achieved by Embios uncompromising emphasis on superior quality of both its products and regulatory compliances, to service the specific requirements of its customers.Embios State of the Art manufacturing facility, approved by US-FDA, WHO-GMP & KFDA, is located in MIDC Mahad on Mumbai-Goa highway that is 175 KM from Mumbai.Our products and services cater to the stringent requirements of a large clientele in more than 55 countries with the major share in regulated markets that includes a few top 10 pharmaceutical companies in the world.
QUALITY ASSURANCE MANAGEMENT SYSTEMIn its continuing legacy to provide uncompromised quality, Embios operational resources are in sync with the global regulatory requirements. The company has built up a complete QMS, encompassing regulatory affairs, QA, QC, DCS enabled production and complete documentation."Quality Systems forms the backbone of the way we do our business"We have comprehensive approach to an effective pharmaceutical quality system that is based on National and International regulations. A highly qualified and experienced team ensures that Good Manufacturing Practices are adhered to at all stages of processing.Quality AssuranceThe Quality Assurance team ensures that National and International regulations are implemented across all our operations to ensure qualitative output at each step. We have requisite infrastructure & expertise to assure effective Quality Management System at each node. Quality ControlA well-equipped and state of the art laboratory ensures stringent quality of all intermediates and finished products. With support of micro lab in organization. The laboratory is equipped with all advanced instruments such HPLC, HSGC, FTIR, UV, Polarimeter, Malvern Particle Size Analyzer etc.Regulatory AffairsThe regulatory affairs section is managed by a competent team with varied experience in filing CTD DMF, US DMFs, KDMF, COS and other registrations required by various International regulatory authorities and individual country specific requirements.
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