TGA Australia APPROVAL OPENS UP AUSTRALIAN MARKETS FOR AMANTA HEALTHCARE
Sterile Water For Injections B.P. ( 5 mL , 10 mL and 20 mL ) and Sodium Chloride Injection B.P.( 5 mL & 10 mL ) products get Therapeutic Goods Administration – Australia approval
Amanta Healthcare, India’s leading manufacturer and marketer of sterile dosages and Blow-Fill-Seal (BFS) specialist, opens a new chapter in Australia with the award of the Therapeutic Goods Administration (TGA) approval for Sterile Water For Injections B.P and Sodium Chloride Injection B.P products manufactured at its Small Volume Parenterals (SVP) facility at Kheda.
The TGA Australia 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). The Australian market, growing at a CAGR of 6.2% is expected to reach USD 42.5 Billion (2020). 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) that subsidizes close to $6.5 bn on over 80 percent 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, Mr 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”.
About Amanta Healthcare:
Amanta Healthcare Ltd., located in Ahmedabad, India – is a versatile manufacturer & marketer of Sterile Liquid Parenterals manufactured using Aseptic Blow – Fill – Seal technology. Both Large & Small Volume Parenteral facilities are ISO certified & cGMP compliant. Amanta’s Small Volume Parenterals facility is MCC – South Africa approved. Founded in 1988 and headquartered in Ahmedabad, Amanta manufactures and markets a range of over 80 sterile dosages spanning Formulations, Fluid therapy, Eye care range, Respules and Irrigation solutions across India and exports to over 77 countries. Nationally, Amanta’s reach extends to 16 states and it has a significant presence in all premium hospitals and institutions. The company’s operations are profitable spanning across three business segments viz. domestic, international and contract manufacturing. Offering customized manufacturing solutions to all major companies of the pharmaceutical industry in India, Amanta is promoted by Bhavesh Patel, a first generation entrepreneur.
By Anita Dhami
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