Over 10 years of commercial manufacturing experience

Current and prospective Pii commercial product portfolios include NDAs, site transfers and specialty pharmaceutical products. Dosage forms include tablets, powders, capsules (powder, pellet and liquid-filled), hard and soft gelatin capsules, semi-solid, and parenteral products.

 

Our cGMP facility is capable of manufacturing and packaging a wide variety of dosage forms for commercial manufacturing, including controlled substances and potent compounds. All projects are supported by full analytical services, quality assurance and complete project management. cGMP facilities are state-of-the-art and contain 50 production rooms, including 22 containment suites for potent compounds, which have been inspected by both the FDA and EMEA. Rooms are suitable for the manufacture of solids, liquids, semi-solids, liquid-filled hard gelatin capsules and soft gelatin capsules and aseptic (vials, syringes and lyophilized products) dosage forms.

 

Capabilities

  • • Solid Oral (tablets, capsules, powders,)

  • • Softgel and liquid fill 2 piece hardshell capsules

  • • Aseptic : Vials, Syringes, and Lyophilized products

  • • Topical: Creams, Ointments and Gels

  • • DEA licenses for Schedules I-V compounds

  • • Potent compounds, including hormones

  • • Technical transfer for existing products

 

Experience

  • • Three product PAI's in 2009, four in 2010, other commercial products approved without an inspection

  • •Currently approved to manufacture 28 commercial products

  • • More than 50 cGMP production suites, including containment suites for potent APIs

  • • 30,000 ft2 warehousing space

Validation (Process, Packaging and Cleaning)

Customer-approved protocols are followed in the processing and packaging stages. Pii writes protocols for process and packaging validation and then these protocols are approved by the customer and performed during the manufacture and packaging of validation batches.

Commercial Production and Capacity

Pii can provide niche manufacturing for small-volume (up to 100 million units) commercial products, including Orphan Drugs, with a total capacity of 2 billion units per annum and maximum batch size of 1,200 kilograms.

In addition to the manufacturing facility Pii has an additional 30,000 square feet of warehouse space.

Compounds Requiring Special Handling

Highly-potent manufacturing services are carried out in one of Pii's 22 state-of-the-art containment suites. Our manufacturing personnel are specifically trained to work with drugs that require special handling procedures to ensure the safety of personnel and to prevent cross contamination.

Schedule I, II, III and IV Controlled Substances

Pii has a U.S. Drug Enforcement Administration (DEA) license for schedule I, II, III and IV compounds for commercial manufacturing.