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Regulatory
Our manufacturing plant is EU GMP Certified. THIS HAS PAVED WAY FOR REGISTERING OUR GONADOTROPINS GLOBALLY.
Our Therapeutic presence is in the domain of the ever-growing and increasing space of infertility. Our Geographical presence is currently in the areas of Asia, Africa, MENA, LATAM, and CIS with the aim to reach EU/USA regions.
We are a CMO with integrated model of supplying both API/DS and FF/DP. We are open for out licensing, co-development and other models of collaboration with global partners, as we expand our footprints to highly regulated markets. We at Sanzyme are experienced in regulatory requirements and understand the dynamic regulatory landscape in the segment of Biologics and Biosimilars. Armed with EU GMP & PICs for Finished Formulations, we offer our e-CTD to cater to global regulatory requirements.
Since 1969, when we entered into a Joint Venture with Sankyo (now Daiichi-Sankyo) to make gonadotropins to export to Japan, we’ve been at the forefront of biological hormones, and today we have the necessary technological foundation to do path breaking work.