Pharmaceutics International
Pharmaceutical International Inc. (Pii), now part of Jabil, is a leading CDMO specializing in complex drug development and manufacturing, including aseptic fill-finish, lyophilization, oral solid dose, and parenteral drugs. With over 30 years of experience, Pii offers flexible, high-quality solutions with a focus on innovation, compliance, and partnership to help clients succeed in bringing complex therapies to market. The company emphasizes operating beyond GMP standards to prevent cross-contamination, ensuring high safety and quality in manufacturing processes. Pii's expertise spans formulation development, analytical testing, stability studies, aseptic manufacturing, and specialized services like soft gel and parenteral drug production. The organization fosters a quality culture that empowers staff to act proactively on contamination risks, and maintains state-of-the-art facilities with advanced equipment. Pii's leadership includes President and CEO John Fowler, and senior scientists like Fei Cai and Sundeep Sethia. The company is FDA registered, cGMP certified, and DEA registered, supporting a broad range of pharmaceutical development and manufacturing needs.
Industries
Nr. of Employees
large (251-1000)
Pharmaceutics International
Hunt Valley, Maryland, United States, North America
Products
Clinical Trial Manufacturing
Supports formulation development and clinical trial manufacturing for drugs and biologics from preclinical through commercial supply.
Solubility/Bioavailability Enhancement
Offers formulation solutions to improve the solubility and permeability of poorly soluble drugs using various technologies.
Lyophilization Cycle Development
Provides lyophilization formulation, cycle development, and optimization services for drugs, including scale-up for GMP manufacturing.
Ready-to-Use 3mL Cartridge
Designed for consistent delivery of high-viscosity, high concentration injectable drug delivery systems.
Fill-Finish Development
Manages the development of parenteral formulations for clinical trials and implements scale-up/Tech Transfer with sterile fill-finish suites.
Aseptic Fill-Finish
Offers aseptic fill-finish services for vials, syringes, and cartridges, including complex formulations and highly viscous solutions.
Clinical Trial Manufacturing
Supports formulation development and clinical trial manufacturing for drugs and biologics from preclinical through commercial supply.
Solubility/Bioavailability Enhancement
Offers formulation solutions to improve the solubility and permeability of poorly soluble drugs using various technologies.
Lyophilization Cycle Development
Provides lyophilization formulation, cycle development, and optimization services for drugs, including scale-up for GMP manufacturing.
Ready-to-Use 3mL Cartridge
Designed for consistent delivery of high-viscosity, high concentration injectable drug delivery systems.
Fill-Finish Development
Manages the development of parenteral formulations for clinical trials and implements scale-up/Tech Transfer with sterile fill-finish suites.
Aseptic Fill-Finish
Offers aseptic fill-finish services for vials, syringes, and cartridges, including complex formulations and highly viscous solutions.
Services
Clinical Trial Manufacturing (Aseptic CTM)
Small-batch sterile manufacturing and supporting services for clinical studies including formulation, manufacturing, on-site analytical testing, and clinical packaging.
Commercial Aseptic Manufacturing
cGMP commercial production for parenteral products including large-scale automated filling, lyophilization integration, terminal sterilization where appropriate, and commercial packaging/serialization.
Formulation Development Services (Parenteral and Oral)
Formulation design and development for parenteral and oral dosage forms, bioavailability enhancement, controlled-release strategies, and processes compatible with highly potent APIs.
Contract Analytical Laboratory Services
Analytical method development, validation, stability studies, batch release testing, compendial and raw material testing aligned to major pharmacopeias.
Physical-Functional Testing
Performance testing for delivery systems and packaged products, including viscosity, container-closure integrity, packaging durability, break-loose/glide force, dose accuracy, and in vitro release.
Raw Material and Compendial Testing
Compendial and in-house testing of starting materials, impurities, heavy metals, and purified water to ensure material quality and supply chain readiness.
Clinical Trial Manufacturing (Aseptic CTM)
Small-batch sterile manufacturing and supporting services for clinical studies including formulation, manufacturing, on-site analytical testing, and clinical packaging.
Commercial Aseptic Manufacturing
cGMP commercial production for parenteral products including large-scale automated filling, lyophilization integration, terminal sterilization where appropriate, and commercial packaging/serialization.
Formulation Development Services (Parenteral and Oral)
Formulation design and development for parenteral and oral dosage forms, bioavailability enhancement, controlled-release strategies, and processes compatible with highly potent APIs.
Contract Analytical Laboratory Services
Analytical method development, validation, stability studies, batch release testing, compendial and raw material testing aligned to major pharmacopeias.
Physical-Functional Testing
Performance testing for delivery systems and packaged products, including viscosity, container-closure integrity, packaging durability, break-loose/glide force, dose accuracy, and in vitro release.
Raw Material and Compendial Testing
Compendial and in-house testing of starting materials, impurities, heavy metals, and purified water to ensure material quality and supply chain readiness.
Expertise Areas
- Aseptic clinical trial manufacturing
- Commercial aseptic manufacturing and scale-up (cGMP)
- Parenteral formulation development and HPAPI handling
- Analytical method development, transfer, and validation
Key Technologies
- Robotic automated aseptic filling systems
- Lyophilization (freeze-drying) equipment and cycle development
- Terminal sterilization techniques
- High-viscosity filling systems