Description
Pharmaceutics International, Inc. (Pii) is a contract development and manufacturing organisation (CDMO) specialising in providing comprehensive drug development solutions to the pharmaceutical and biotechnology industries.
Founded in 1994 and headquartered in Hunt Valley, Maryland, Pii offers customised services across all phases of drug development, from preclinical stages through to commercial supply. The company is dedicated to empowering clients' drug development journeys by delivering tailored solutions that enhance patient outcomes.
Key Products and Services:
- Formulation and Process Development: Pii provides expertise in both oral and parenteral drug development, including solubility and bioavailability enhancement, lyophilisation cycle development, and handling of highly potent active pharmaceutical ingredients (HPAPIs), hormones, and controlled substances.
- Aseptic Manufacturing Services: The company offers aseptic fill-finish capabilities for various dosage forms, such as prefilled syringes, 3mL cartridges, and lyophilised products, ensuring sterility and quality in drug manufacturing.
- Oral Drug Development: Pii specialises in the development of oral dosage forms, including soft gel capsules, with a focus on enhancing solubility and bioavailability of poorly soluble drugs.
- Contract Analytical Services: The organisation provides comprehensive analytical support, including method development, validation, and stability testing, to ensure the quality and compliance of pharmaceutical products.
- Tech Transfer and Manufacturing: Pii manages technology transfer processes and offers both clinical trial and commercial manufacturing services, ensuring seamless scale-up and production continuity.
With a commitment to quality and innovation, Pii partners with clients to navigate the complexities of drug development, providing flexible and efficient solutions that meet the evolving needs of the pharmaceutical industry.
Capabilities
- Analytical Services
- Asceptic Fill-Finish
- Clinical Dose
- Clinical Packaging
- Compounding
- Containment
- Contract Development and Manufacturing (CDMO)
- Drug Development
- Injectables
- Lyophilization
- Non Sterile Dosage
- Oral Drug Delivery
- Packaging
- Parenterals
- Preformulation
- Process Development
- Process Validation Studies
- Regulatory Services
- Soft Gels
- Solid Dosage
- Syringe
- Technology Transfer
- Vials
Contact Information
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