The Therapeutic Goods Administration of Australia (TGA) has granted pharmaceutical company Phebra the license for its new manufacturing plant in Sydney on Monday.
“This is a great day for Phebra, our staff and all of our contractors who have worked together on the project over the past three years,” said Dr. Mal Eutick, Phebra’s Chief Executive Officer.
Phebra, a privately owned pharmaceutical company, was established in 1993 as a distributor of speciality pharmaceutical products. Today the company markets a range of products that include anti-infectives, oncology and pain medication, medicine for cardiovascular and respiratory diseases, and vitamins, among others. Phebra is focused on marketing specialty pharmaceuticals to the hospital market in Australia and via distributers in New Zealand, Asia, Canada and Europe.
Meanwhile, the TGA is part of the Australian Government Department of Health and Ageing, and is responsible for regulating therapeutic goods including medicines, medical devices, blood and blood products. It regulates manufacturers of therapeutic goods to ensure they meet acceptable standards of manufacturing quality.
The license for the Lane Cove West manufacturing plant was given after it passed TGA’s strict assessments, which include an ongoing series of product validations. Dr. Eutick believes this all the more confirms the company’s compliance to good manufacturing practice guidelines (GMP).
“Our General Manager Andre Vlok and Manufacturing Manager Stephen Kenny, in particular, have worked closely with the TGA to ensure that Phebra has successfully completed the regulatory requirements for our manufacturing licence.
“The plant is testament to Phebra’s investment in the future of the local manufacturing industry.”
Validation manufacturing in the new plant began in December 2012. In the media release Eutick credited Phebra’s General Manager Andre Vlok and his staff for planning and working intensively to bring the project into fruition. He also said the manufacturing of the validation batches allowed the successful operation of Phebra’s new multi-million dollar Bosch integrated filling machine inside the plant’s multi-purpose sterile injectables unit.
Industry and Innovation Minister Greg Combet acknowledged the input of the Australian pharmaceutical industry to the overall economy when he opened the plant in March, saying it “employs 40,000 Australians, generates export earnings of around $4 billion a year and invests more than $1 billion a year in research and development.”
In line with Combet’s statement, Dr. Eutick said that the new plant will enable Phebra to amplify its research and production capacity for the Australian and overseas markets.
“We will be manufacturing our ever-growing range of critical medicines, including emergency injectables, antidotes and other small volume injections.
“We will also be expanding our capability to conduct all-important development programs now and into the future, providing skills development and employment for Australian scientists and medical researchers.”