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Amanta Healthcare’s products get approval from TGA Australia


The approvals are for Sterile Water for Injections B.P (5 mL, 10 mL and 20 mL) and Sodium Chloride Injection B.P (5 mL & 10 mL) manufactured at its SVP facility at Kheda

Amanta Healthcare, manufacturer and marketer of sterile dosages and blow-fill-seal (BFS) specialist, has received Therapeutic Goods Administration (TGA) approval in Australia for its Sterile Water For Injections B.P (5 mL, 10 mL and 20 mL) and Sodium Chloride Injection B.P (5 mL & 10 mL) products manufactured at its Small Volume Parenterals (SVP) facility at Kheda.

The Australian market, growing at a CAGR of 6.2 per cent is expected to reach $ 42.5 billion (2020). Growth will be largely driven by increasing demand for lifestyle disease drugs among ageing population; the uptake of new, expensive drugs; and strong government support for generics. The Australian Government’s Pharmaceutical Benefit Scheme (PBS) that subsidises 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.

The Therapeutic Goods Administration is part of the Australian Government Department of Health and Ageing. The TGA’s overall purpose is to protect public health and safety by regulating therapeutic goods that are supplied either imported or manufactured, or exported from Australia. It is responsible for administering the provisions of the Therapeutic Goods Act 1989. The TGA is responsible for ensuring that therapeutic goods available for supply in Australia are safe and fit for their intended purpose. Broadly, this involves undertaking activities to ensure that therapeutic goods available in Australia are of an acceptable standard.

Speaking on the TGA Australia approval, 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”.

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