Our portfolio includes anti-cancer drugs (specialising in cytotoxics), anti-psychotics, antibiotics, narcotics and anti-inflammatory drugs, and we have built and validated new ‘state-of-the-art’ cGMP manufacturing facilities to accommodate this product range.

IDT has a number of manufacturing facilities:

• Facility A contains a 60L facility for small-scale production of API’s for human and veterinary use;
  
  
• Facility B contains two plant rooms - an upstairs plant room containg 60L reaction vessels and a downstairs plant room containing 250L reactors. Facility B is a containment facility for the production of anticancer (cytotoxic) APIs;
  
  
• Facility C contains 2000L reactors for large-scale production of non-cytotoxic APIs particularly those for parenteral use;
  
  
• Facility D contains a cleanroom manufacturing area for the small scale production of finished dosage forms for clinical trial use;
  
  
• Facilities E, K, L and R each contain cleanroom containment facilities designed for manufacture of highly toxic or active materials such as cytotoxics and cephalosporins, on a small scale;
  
  
• Facility F is an area dedicated for the manufacture of small scale non-toxic materials;
  
  
• Facility V is a biological containment facility for the preparation of viral vaccines.

New facilites are planned as a part of IDT’s next expansion phase.

Our Facilities are dedicated to manufacturing batches ranging in size from laboratory scale (grams) to multi kilogram commercial scale (up to 250 kg per batch) using multistep chemical synthesis. We utilise and maintain cleanrooms of Class 100,000 for product isolation and manufacture. As the plants have been designed to manufacture several different APIs, we have implemented stringent measures to ensure that cross-contamination is not possible. These measures place emphasis on validated cleaning procedures, including rinse and swabbing techniques.

All of our staff are highly qualified in appropriate scientific areas, and they understand the need to adhere to all relevant standards during drug development and manufacture. The manufacture of pharmaceutical products must comply with the current Good Manufacturing Practices (cGMPs), which ensure that quality is involved with every aspect of manufacture to ensure that the product will always meet defined quality standards.

Our quality systems have been designed to exceed all international regulatory requirements, and have passed scrutiny from various regulatory bodies. This was highlighted by the fact that IDT did not receive any 483 citations when inspected by the FDA in May 1998. IDT is regularly inspected by the Therapeutic Goods Administration of Australia (TGA) and the US FDA.

As a specialist organisation that has a culture built on the importance of quality, we take pride in the fact that we work as a flexible team, meet tight deadlines and budgets, and continually deliver products and services of the highest standard.

E-mail : manufacturing@idtaus.com.au