IDT Australia (Institute of Drug Technology Limited)

Company Overview

Name: Institute of Drug Technology Limited (IDT Australia)

Mission: To improve and save lives through the development and reliable manufacture of effective and innovative pharmaceutical vaccines and treatments.

Founded: 1975

Founders: Conceived by the Dean of the Victorian College of Pharmacy Nigel Manning and his colleagues.

Key People:

No information is available.

Headquarters: 45 Wadhurst Drive, Boronia, Victoria 3155, Australia

Number of Employees: No information is available.

Revenue: No information is available.

Known For:

Alleviating critical drug shortages.

Partnering with researchers to develop essential therapies for illnesses such as cancer, heart disease, diabetes, mental health conditions, and Alzheimer’s.

Specializing in high containment, high potency Active Pharmaceutical Ingredients (API) and Finished Dose Forms (FDF).

Expertise in advanced therapies including mRNA and Antibody Drug Conjugates (ADCs).

Accredited cGMP manufacturing facility.

Products

1. Advanced Therapies

Description: Involves collaboration with researchers and university partners for the development and manufacturing of mRNA and ADCs, from preclinical pilot stages to commercial scale.

Key Features:

mRNA-based treatments.

ADCs for targeted cancer treatments.

2. Specialty Orals

Description: Solid dose oral forms including tablet and capsule formulation as well as liquid dose oral form.

Key Features:

Facilities for medicinal cannabis processing and extraction.

Conversion of products to finished dosage forms.

3. Active Pharmaceutical Ingredients (API)

Description: Synthesis of APIs and their intermediates, ranging from milligrams to kilogram scales.

Key Features:

High potency and high containment manufacturing.

End-to-end integration from API development to finished dose forms.

Recent Developments

Recent Developments:

No specific recent developments are available.

New Products Launched:

No information is available.

New Features Added to Existing Products:

No information is available.

New Partnerships:

No information is available.

Regulatory Compliance

Regulatory Authorities:

Australian Therapeutic Goods Administration (TGA)

U.S. Food and Drug Administration (FDA)

European Mutual Recognition Agreement (MRA)

Japanese Ministry for Health Labour and Welfare (JMHLW)

Licenses:

GMP Certification and Licences to Manufacture Therapeutic Goods

Medicinal Cannabis Manufacture Licence

Licence to Manufacture and Sell or Supply by Wholesale Schedule 8 or Schedule 9 Poisons

Conclusion

IDT Australia embodies a significant experience and capability in pharmaceutical manufacturing and development. Operating under stringent regulatory compliance, it provides a diversified portfolio specializing in advanced therapies, specialty oral formulations, and APIs. Reputed globally, IDT continues to innovate, providing essential pharmaceuticals to mitigate drug shortages and support advanced medical research.

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