Manufacturing Facility

Home Manufacturing Facility

Manufacturing unit is located 147km away from Mumbai in Achhad Industrial area (Maharashtra, India) in a pollution free environment surrounded with lush greenery providing a perfect place to produce genuine quality medical devices. The facility is constructed under strict norms adhering to the standards of FDA, and GMP and other state government regulations. The products manufactured conform to ISO standards, and European norms.

The facility provides state of the art clean room (area 2000 sq. ft.) for assembling of medical devices, with class 10,000 pre cleaning area and class 10,000 assembling area. All the products are primary packed under class 100 laminar air flow, the facility is equipped with a 24 CF fully automatic double door ETO sterilizer to ensure product quality is maintained throughout the manufacturing process without any contamination issues and 100 % product sterilization.

Plant Approval

  • FDA (Maharashtra India)
  • CE Certificate
  • ISO 13485:2016
  • CDSCO