Amanta Healthcare gets TGA-Australia approval for Kheda facility

Amanta Healthcare, a manufacturer and marketer of sterile dosages and Blow-Fill-Seal (BFS) player, informed that the company has received the Therapeutic Goods Administration (TGA) approval for its two products manufactured at its Small Volume Parenterals (SVP) facility at Kheda.

The approval from TGA, an arm of the Australian Government's Department of Health and Ageing, will enable Amanta Healthcare to access the Australian markets with products Sterile Water For Injections B.P. (5 mL , 10 mL and 20 mL) and Sodium Chloride Injection B.P. (5 mL & 10 mL).

Commenting on the development, Bhavesh Patel, MD, Amanta Healthcare, said, “The TGA - Australia approval for our Kheda facility will provide further impetus to our current expansion efforts in stable growth economies. Australia’s health expenditure will continue to increase with the increasingly ageing population. The focus on lifestyle disease management presents robust growth possibilities. I see strong revenue potential in the Australian market and believe that we can make a quantum contribution to healthcare in the various segments”.

According to the company, the Australian market, growing at a CAGR of 6.2 per cent is expected to reach $ 42.5 billion by 2020. The growth will be largely driven by increasing demand for lifestyle disease drugs among aging population, the uptake of new, expensive drugs and strong government support for generics.

The Australian Government’s Pharmaceutical Benefit Scheme (PBS) currently subsidizes close to $ 6.5 billion on over 80 per cent of drugs in Australia.

Beside the ongoing reduction in PBS subsidy, the Australian government also supports the trading of generic drugs, given that the cost of purchase is far lower than its branded equivalent.

"Together with the subsidy reduction and government support for generics, many physicians will soon prefer to prescribe mostly generics to their patients. For Amanta Healthcare, the approval carries the opportunity of accessing Australia’s fastest growing segments," it said.

TGA is responsible for administering the provisions of the Therapeutic Goods Act 1989 in Australia.