Pii
10819 Gilroy Road
Hunt Valley, MD 21031
T: (410) 584-0001
E: bd@pharm-int.com
W: www.pharm-int.com


ABOUT US

Know-How to Deliver Your Product
Pharmaceutics International Inc. (Pii) is a reliable, proven CDMO bringing over 25 years of know-how, commitment to customers’ individual needs, and flexibility across product development and cGMP manufacturing.

Pii offers a full range of contract development and manufacturing services to global pharmaceutical innovators, providing support from pre-formulation development through clinical and commercial-scale production, with a track record of success in rapid early-stage progress.

Our scientific teams have wide-ranging experience optimizing complex compounds for a variety of dosage forms, including:

  • Steriles (Vials, Syringes, Cartridges & Lyophilized)
  • Injectables (Aqueous & Non-Aqueous)
  • Oral Solids (Tablets, Capsules, Softgels)
  • Oral Liquids (Suspensions, Syrups & Solutions)
  • Topicals
  • Potent Compounds, Hormones & Cytotoxics
  • Controlled Substances (Schedules I – V)
  • Solid Dispersions
  • Controlled-Release Formulations

Know-How to Advance Sterile Products
With extensive experience in aseptic processing and the recent addition of a new fully-robotic filling machine, Pii is able to efficiently deliver high-quality sterile drug product, with the flexibility to accommodate customers’ clinical and commercial manufacturing needs. By automating the fill-finish process, customers benefit from greater manufacturing productivity, while mitigating the risk of contamination with minimized operator intervention.

Know-How to Deliver on Our Relationship
Pii’s approach is one of collaboration, transparency, and flexibility. Through experience completing more than 400 development programs across a broad range of compounds, we know and value the importance of listening to customer needs and responding to challenges with speed and agility.

cGMP FACILITIES

Pii operates over 360,000 square feet of state-of-the-art pharmaceutical development and manufacturing space in Hunt Valley, Maryland. This includes over 70 flexible manufacturing suites, several with the required containment controls for handling potent compounds and hormones, as well as a dedicated suite for the production of soft gel capsules. Our facilities are cGMP qualified and include dedicated formulation development centers for oral solid, liquid and sterile products.

PRODUCTS & SERVICES

  • Pre-Formulation Studies
  • Dosage Form Development & Manufacturing
    – Fluid-Bed Processing (Solvent & Aqueous)
    – Micro & Nanotechnologies
    – Coating (Aqueous & Solvent)
  • Analytical Development & Testing
  • CTM Manufacturing
  • Commercial Manufacturing
  • Serialization
  • Clinical Packaging & Distribution
  • Regulatory Support
  • Quality Management
  • Commercial Packaging

Analytical Services

  • Early Development Stability
  • Excipient Compatibility
  • Component Compatibility
  • Solubility Screening
  • Thermal Cycling and Freeze-Thaw
  • Photo Stability
  • Microbiology

Regulatory Affairs

  • Electronic Common Technical Documents (e-CTD) Preparation & Amendments
  • Lifecycle Management for Approved Applications
  • Regulatory Assessment of Post-Approval Changes, Strategy & Supplements
  • Labeling Services (ANDA)

Quality Assurance

  • Process Performance & Product Quality Monitoring
  • Corrective Action & Preventive Action (CAPA)
  • Change Management
  • Internal, Customer & Regulatory Inspections