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Oral Finished Dose

 

Leading the Way in the Development and Manufacturing of Oral Finished Doses

As a distinguished leader in the development and manufacturing of oral finished doses, IDT is at the forefront of the pharmaceutical industry. With our extensive capabilities, we excel in the conversion of in-house produced APIs and the seamless tech transfer of products developed in collaboration with formulation houses.

As a specialist manufacturer of finished dose forms, we provide comprehensive support for pre-clinical and clinical studies ranging from Phase I to Phase III, as well as commercial supply. Our expertise extends to solid dose oral forms as well as liquid dose oral forms, facilitated by our state-of-the-art facilities equipped to handle high potency and high containment requirements.

As a trusted CDMO, IDT prioritises exceptional quality and regulatory compliance in oral finished dose manufacturing. Through strong collaboration with MMIC, we deliver innovative pharmaceutical solutions, exceeding client expectations and advancing healthcare outcomes.

Find out how IDT Australia can support your next project

IDT specialises in the bespoke manufacture of solid dosage forms tailored to meet the specific needs of clinical batches from Phase I to Phase III. With extensive experience in manufacturing clinical materials, IDT excels in supporting fully blinded studies. Our capabilities set us apart in several key aspects:

  • On-Site Support: IDT provides comprehensive on-site support for the manufacturing process, including the manufacture, chemistry, and microbiological testing of finished products, as well as stability studies. 
  • Streamlined Processes: We eliminate the challenges associated with multiple tech transfers by handling product transitions within the same expert team. This streamlined approach ensures efficiency, consistency and minimises delays.
  • Expertise and Quality Assurance: IDT's team of experts possess extensive knowledge and expertise in manufacturing solid dosage forms, allowing for precise execution of clinical batches. Our robust quality system ensures that all products meet stringent standards and regulatory compliance.

At IDT, we are committed to delivering exceptional services that support the development and manufacturing of oral finished doses. Our integrated approach and dedication to quality assurance guarantee reliable results and accelerate the progress of clinical studies.

IDT operates as a reputable pharmaceutical manufacturer in a strictly regulated cGMP environment, with a focus on the development and manufacturing of oral finished doses. Our facility has successfully undergone comprehensive audits and received accreditation from established regulatory authorities, including the Australian Therapeutic Goods Administration, the U.S. Food and Drug Administration, and the Japanese Ministry for Health Labour and Welfare.

Additionally, our commitment to upholding high-quality GMP standards extends to Europe and Canada through The Mutual Recognition Agreement. These certifications validate our dedication to adhering to stringent quality control measures and complying with international regulatory requirements specific to the development and manufacture of oral finished doses.

Full-Spectrum API Manufacturer (CDMO)

As a specialised pharmaceutical manufacturer, IDT excels in the manufacture, chemistry, and microbiological testing of oral finished products. With on-site support and a unified quality system, we ensure seamless coordination throughout the entire development process. Our dedicated team of experts handles product transitions from manufacture through analysis and release, eliminating the complexities of multiple tech transfers.

IDT is well positioned to address the increasing demand for oral finished doses, particularly in combination therapies across various therapeutic areas. Our unique advantages include:

  • HPAPI Specialisation: Efficient access to key compounds for oral finished doses across therapeutic areas.
  • Full Support: End-to-end services from research to market launch, ensuring seamless coordination.
  • Oral Dose Expertise: Strong capabilities in developing innovative oral finished doses.

Leveraging our specialised capabilities, researchers and pharmaceutical companies can accelerate oral finished dose development, offering effective treatments across a wide range of therapeutic areas.

Contact IDT Australia

If you’re looking for quality, turnkey cGMP contract manufacturing services, please get in touch with us today.