Control Print soars over 4% after receiving USFDA 510(k) authorisation for surgical masks

25 Jan 2022 , 10:19 AM

Control Print Limited is the fourth Indian mask manufacturer since the Covid-19 outbreak in 2020 to receive the USFDA 510(k) authorisation, one of the most rigorous regulatory compliances and globally accepted certification for surgical masks.

The 510(k) certification endows The Mask Lab, a venture by Control Print Limited, the marketing authorisation needed to supply the US healthcare and business community, including the public, with the world’s highest quality medical-grade 3 Ply surgical masks to protect from the transfer of microorganisms, body fluids, and particulate material.

The company stock was in demand despite weak markets early on Tuesday. At around 9.52 AM, Control Print Ltd was trading at Rs408.90 per share up by Rs16.15 or 4.11% from its previous closing of Rs392.75 per share on the BSE.

“The FDA approval affirms our 3 Ply surgical masks as one of the world’s premier quality masks in terms of safety and performance. It is a testament to our rigid regulatory process in manufacturing truly world-class medical products. With our robust infrastructure, advanced manufacturing technologies, and ability to rapidly scale production at The Mask Lab, we plan to meet the rising demand of healthcare facilities, medical equipment suppliers, and large businesses across the US, Europe, Asia, and major global markets,” says Basant Kabra, Managing Director at Control Print Limited.

“When the Covid-19 outbreak began, we swiftly ramped up our manufacturing capabilities to help Indian frontline workers with the domestic face mask shortage, including corporations with large workforces like Unilever, Tata Group, ITC Limited, United Breweries and hotels of the Taj group. We are ready to play a key role in restraining the current pandemic and equipping the world to be more prepared for the next similar challenge,” says Shiva Kabra, Joint Managing Director at Control Print Limited.

The USFDA 510(k), BIS, CE, and ISO 13485 certifications establish that The Mask Lab’s products are safe and effective for human use after extensive third-party testing for engineering performance, sterility, safety, and biocompatibility, attaining legal approval for commercial distribution worldwide.