The 4th facility from Healthium to receive US FDA registration
Bangalore, December 08, 2021
National, 8 December, 2021: Healthium Medtech Limited (“Company” or “Healthium Medtech”) , a global medical devices company focused on surgical, post-surgical and chronic care, today announced that the company has received US FDA (U.S. Food and Drug Administration) registration for its manufacturing facility in Sri City, Andhra Pradesh.
Healthium Medtech is India’s largest independent medical devices company in the surgical consumables market, the largest non-captive surgical needles manufacturer globally, by volume and the third largest company overall in the urology collection devices market in the U.K as of fiscal 2021.
Based on the focus placed in creating high-quality precision- based medical devices, Healthium’s manufacturing facilities are subjected to rigorous quality control checks and periodic inspections from various regulatory agencies across the world. The accreditation of our manufacturing facilities reiterates our focus towards patient safety and is an essential requirement for our products to be used in the treatment of patients globally. As on 31st March, 2021, one in five surgeries conducted globally, uses a Healthium product.
Healthium Medtech operates across eight integrated and scaled manufacturing facilities, several of which have global accreditations and registrations including with US FDA, CE, TGA, CDSCO and ISO. It is the only company in India with a CE-certified surgical needles manufacturing facility as on March 31, 2021.Healthium was the first Class III medical device company in India to receive a US FDA registration for one of its facilities. With this announcement, the Sri City plant becomes the fourth US FDA registered Healthium facility. It also has CDSCO, ISO 9001:2015 and EN ISO 13485: 2016 certifications.
Healthium commenced its operations at the Sri City facility in calendar year 2012. The facility manufactures sutures, meshes with a production capacity of 1.20 million, as per the fiscal of 2021, and is located in a special economic zone (SEZ).
Speaking on the recent development, Mr. Anish Bafna, Chief Executive Officer and Managing Director, Healthium Medtech said, “We are delighted to receive the US FDA registration for our Sri City facility in Andhra Pradesh, our 4th facility to receive it. This is testimony to our commitment to operational excellence and to our focus in delivering high quality, safe, value driven products aligned with our vision “Access to precision medtech for every patient, globally”
