Transasia receives US FDA registration certification

Transasia Bio-Medicals Ltd. announced that all its in-vitro diagnostic instruments manufactured in Mumbai are now US FDA registered.

Image by Lewis Keegan - from Unsplash

Transasia’s ‘Made in India’ products which are currently exported to over 100 countries will now also be available in the USA.

Mr Suresh Vazirani, Chairman & Managing Director, Transasia-Erba group said: “For over four decades Transasia Bio-Medicals Ltd. has been at the forefront of contributing to a ‘self-reliant India’ by developing and manufacturing innovative and affordable diagnostic solutions. Way back in the 1990s, much before the Make in India concept came into existence, Transasia was already manufacturing all its instruments indigenously and received the CE certification, which allowed the use of its products in the European market.”

Mr Ravi Kaushik, CEO, Transasia Bio-Medicals Ltd said: “Stringent quality systems norms are in place at all our manufacturing facilities. Our Mumbai plant was subjected to rigorous quality system checks and GMP requirements laid down by US FDA authorities as per 20 CFR 820. We are proud that we are recognized as being compliant to global standards and have received the US FDA registration.”

To boost exports, Transasia recently inaugurated another state-of-the-art facility at Mumbai. The expansion is set to boost the annual production capacity of the plant by 50% and facilitate the manufacturing and export of new products which are currently in the pipeline and are likely to be launched shortly. The new plant has already been certified by ISO 13485: 2016 and ISO 9001: 2015 and was commissioned and made operational within three months.

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