Lords Mark Industries501261Regulatory approval
US FDA registration for 200+ products; Silvassa expansion completed ahead of schedule
Lord's Mark Industries says it is Asia's first company to secure US FDA registration for more than 200 surgical, medical-care and hygiene products.
By ScoutQuest · · 2 min read
- FDA registration scope
- more than 200 surgical, medical-care and hygiene products
- US export start
- December 2026
- Silvassa capacity expansion
- completed ahead of schedule
What the company announced
- Lord's Mark Industries says it has secured US FDA registration for more than 200 surgical, medical-care and hygiene products, and describes itself as Asia's first company to do so.
- Exports to the United States are planned to begin in December 2026.
- The manufacturing capacity expansion at Silvassa has been completed ahead of schedule, which the company links to production readiness for international markets.
Product range covered
- Orthopaedic and rehabilitation supports such as cervical collars, lumbar supports, abdominal belts, rib belts, chest binders, shoulder immobilisers, arm slings, splints, knee and ankle braces, compression stockings and posture correctors.
- Mobility and care aids such as walking sticks, walkers, wheelchairs, commode chairs, orthopaedic cushions and heel cups.
- Hygiene and medical-care items including disinfectant and cleansing wipes, elastic adhesive bandages, cotton crepe bandages, adult diapers, sanitary napkins, hot and cold gel packs and medical tourniquets.
The company's plan
- The United States is stated as the immediate export priority.
- South America is described as a potential avenue for further expansion, and entry into individual markets will depend on product-specific registration, import and distribution requirements.
- The company plans to pursue partnerships with international distributors, healthcare suppliers and institutional buyers.
Market size cited (Mordor Intelligence estimates)
- United States general surgical devices market: US$6.69 billion in 2025 to US$9.67 billion by 2031, a CAGR of 6.35%.
- South American general surgical devices market: US$1.37 billion in 2025 to US$2.19 billion by 2031, a CAGR of 8.20%.
- The update notes these are broad market estimates and that the addressable market for the company will depend on individual product categories and applicable regulatory requirements.
How to read this
- The announcement is about a regulatory registration, a completed capacity expansion and stated export intentions; the export start is described as planned for December 2026, and South America is at the exploration stage.
- The registrations and the Silvassa completion are described as done, while the export business, distributor tie-ups and South America entry are forward-looking plans subject to rules in each market.
- The market-size figures are third-party industry projections for the overall device market, not a forecast of the company's own revenue.
Management comment
- Dr. Sachidanand Upadhyay, Founder, Managing Director and CEO, said the certification reflects the company's regulatory compliance team and product quality, and that the early completion of the Silvassa expansion strengthens its readiness to serve international markets.
Also from Lords Mark Industries
Board to consider Rs. 100 Crore unsecured loan from promoter with option to convert into equity
19 Oct 2026
Board approves appointment of Whole-Time Company Secretary and Compliance Officer
14 Oct 2026
Lord's Mark Industries completes acquisition of Radio Electric (Radiotone brand) for 4.50 Cr cash
12 Oct 2026
More numbers
- Products with US FDA registrationmore than 200
- US general surgical devices market, 2025US$6.69 billion
- US general surgical devices market, 2031US$9.67 billion
- US market CAGR6.35%
- South America general surgical devices market, 2025US$1.37 billion
- South America general surgical devices market, 2031US$2.19 billion
- South America market CAGR8.20%
Source: BSE · 23 Oct 2026
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