We Know Sterile Manufacturing


Ausia’s heritage and accomplishment is built on over 20 years of practice in pharmaceutical manufacturing. 1993, the company bought 2 freeze-dryers of 5m2 and 20 employees set out to manufacture Ausia’s first batch of powder for injectables -- Ribonucleic Acid III. From there, Ausia continued its journey of sterile manufacturing and never looked back. Market opportunities and technological advances took us from doing simple, small scale freeze-drying to handle complex aseptic processing operations and a production volume of 200 million vials per year.

On the other hand, those great leaps and expansions never hindered our focus on the corporate principle – Quality First. We obtain GMP approval from the China FDA since it implemented the newest edition of regulation in 2010. To us, merely obtaining regulatory compliance is a minimalist’ job. Delivering quality product to advance patient care is our true passion. We are committed to continue this philosophy with a relentless focus and delivery the results you truly deserve.

A Brief History Overview


1993

Ausia BioTech was founded by Hangzhou Kangle Life Science Research Firm and an investment firm from Australia.

1994

Ausia finished construction of its first sterile manufacturing facilities and began to produce lyophilized powder for injections. At the end of year, annual production volume reached 1 million vials.

1995

Ausia opened sales offices in Beijing, Shanghai and several other cities to develop domestic market for its in-house products, mainly an array of antibiotics.

2000

Ausia purchased a 40,000m2 compound in Hangzhou Economic and Technology Development Zone (HETZ). Construction started immediately to build a sterile manufacturing facility capable of produce 40 million vials annually.

2002

After the production facility obtained China FDA (SFDA) approval, Ausia formally relocated to the newly completed facility in HETZ. The Company expanded its administrative, research and laboratory functions as well.

2003

Ausia BioTech acquired major ownership in Zhejiang Ausia Institute of Bioengineering Research. The institute serves as a public service platform for bioengineering research under the municipal government.

2006

Ausia expanded its lyophilization capacity with installation of 2 lyophilizers of 20m2 and 2 linear washing/drying/filling line.

2007

Ausia re-identified its business model as a Contract Manufacturing Organization, devoting over 95% of its resources to CMO operations.

2009

Three 40m2 lyophilizers and 1 linear washing/drying/filling line were installed, expanding the company’s production capacity.

2011

Ausia passed SFDA inspection under the new edition of GMP regulations.

2012

Construction of a brand new, independent production facility was completed and obtained SFDA approval. This 8 million dollar project includes 4 lyophilizers of 45m2, 2 linear washing/drying/filling lines and other state-of-art equipment. Ausia’s production capacity is now up to 200 million vials annually.


 
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