• US FDA registration opens the doors for Transasia’s ‘Made in India’ to be available in the US market
• All instruments are CE certified and in use in over 100 countries
• State-of-the-art Mumbai manufacturing facility is already certified to be compliant to various quality system norms in India

 India’s leading IVD Company, Transasia Bio-Medicals Ltd. today announced that all its in-vitro diagnostic instruments manufactured in Mumbai are now USFDA registered. What this means is that Transasia’s ‘Made in India’ products which are currently exported to over 100 countries will now also be available in USA.

“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.” said Mr. Suresh Vazirani, Chairman & Managing Director, Transasia-Erba group.

“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”, said Mr. Ravi Kaushik, CEO, Transasia Bio-Medicals Ltd.

In order 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 in the near future. The new plant has already been certified by ISO 13485: 2016 and ISO 9001: 2015 and was commissioned and made operational in a record time of less than three months.

Infact, in 2019, Transasia became the first IVD Company in India to be awarded the ZED Diamond Quality rating from the Ministry of MSME, and the Quality Council of India for its manufacturing facility at Mumbai (Seepz). And in 2018, it became the first Indian IVD Company to receive the ICMED 13485 quality certificate; the country’s first indigenous QA system for India manufactured medical devices.