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Published
Sep 7, 2021
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Welspun becomes first Indian business to receive USFDA approval for 3-ply masks

Published
Sep 7, 2021

Textile business Welspun announced that it is the first Indian company to receive approval from the US Food and Drug Administration for its 3-ply surgical masks. 

Welspun India can now export its surgical masks to numerous countries worldwide - DR

 
Welspun’s 3-ply surgical mask USFDA 501 (k) approval will enable the business to export the masks to global markets and increase distribution. The certification is one of the world’s most recognised quality approvals, ET Bureau reported.
 
“Certified by BIS and CE already, this product from Welspun India Ltd has got all required certifications to supply to global markets including critical medical uses,” said Welspun in a statement, the Press Trust of India reported. “This is one of the tedious pre-market submissions made to FDA to demonstrate that the medical device to be marketed is as safe and effective.”

“This is a remarkable validation of our philosophy of keeping 'people ahead of everything' and we will channelise the momentum to further take the quality of healthcare products a notch higher at the global stage,” said Welspun India’s managing director and CEO Dipali Goenka, the Press Trust of India reported. 
 
Welspun focused on surgical mask production during the pandemic to meet the increased global demand and work within retail restrictions which only enabled the sale of ‘essential products’. As the pandemic continues, the demand for surgical masks is expected to remain high. 
 
Welspun India is part of international business Welspun Group which distributes its products in over 50 countries worldwide. The global business is valued at around $2.7 billion (Rs 17,962.4 crore). 

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