Pharmaceutical International Inc.


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

Health Care
Clinical Trials
Manufacturing
Pharmaceutical
Pharmaceutical Manufacturing

Nr. of Employees

large (251-1000)

Pharmaceutical International Inc.

Hunt Valley, Maryland, United States


Products

Aseptic Manufacturing Services

Comprehensive aseptic fill-finish manufacturing services for complex formulations including vials, syringes, and cartridges, supporting small-batch clinical trials up to commercial scale.

Aseptic Fill-Finish and CDMO Solutions

Custom CDMO solutions for complex aseptic challenges, handling high-potency, viscous, and DEA-controlled substances with batch sizes up to 1,000L.

Commercial Drug Manufacturing

Commercial drug product manufacturing services for parenteral products offering cGMP-certified quality, tech transfer, batch scalability, and full regulatory support.

Prefilled Syringe Contract Manufacturing Services

Contract manufacturing services for prefilled syringes, prioritizing patient ease with precise dosing, aseptic fill-finish solutions, and scalable production from small batches to full-scale commercial manufacturing.

Aseptic Drug Manufacturing

Sterile fill-finish services for tough drug products, delivering safe and on-time aseptic manufacturing.

Liquid Vials Services

Expert aseptic vial filling services offering high-quality, compliant solutions for both small molecule and biologic drug products across small and large-scale production.

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Services

Small-batch sterile manufacturing and supporting services for clinical studies including formulation, manufacturing, on-site analytical testing, and clinical packaging.

cGMP commercial production for parenteral products including large-scale automated filling, lyophilization integration, terminal sterilization where appropriate, and commercial packaging/serialization.

Formulation design and development for parenteral and oral dosage forms, bioavailability enhancement, controlled-release strategies, and processes compatible with highly potent APIs.

Analytical method development, validation, stability studies, batch release testing, compendial and raw material testing aligned to major pharmacopeias.

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.

Compendial and in-house testing of starting materials, impurities, heavy metals, and purified water to ensure material quality and supply chain readiness.

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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
  • Show More (8)

Key Technologies

  • Robotic automated aseptic filling systems
  • Lyophilization (freeze-drying) equipment and cycle development
  • Terminal sterilization techniques
  • High-viscosity filling systems
  • Show More (10)

News & Updates

Jabil Inc. announced the acquisition of Pharmaceutics International, Inc. (Pii), a CDMO specializing in aseptic filling, lyophilization, and oral solid dose manufacturing, completed February 3, 2025.

Pii announced a significant expansion of its prefilled syringe capabilities with a $3.6 million investment in advanced labeling, fill/finish, and automated visual inspection technologies.


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