Soft Gel Capsules, Tablets and More

A trusted commercial manufacturing partner, Pii provides contract manufacturing for solid, liquid, topical and injectable dosage forms. The combination of our FDA and EMA inspected facilities, technology transfer and scale up experience and access to seasoned formulation scientists provide you with the service and confidence you need to bring your product to market successfully. All projects are supported by full analytical services, quality assurance and complete project management.

Experience:

• Currently approved to manufacture commercial products for US and internationally
• Successful inspections with the FDA, EMA and other international regulatory agencies
• More than 50 cGMP production suites, including containment suites for potent APIs
• 30,000 ft2 warehousing space
• Technical transfer for existing products

Capabilities:

• Solid Oral (tablets, capsules, powders,)
• Softgel and liquid fill two-piece hardshell Capsules
• Aseptic Fill: Vials, Syringes & Lyophilized Products
• Topical: Creams, Ointments and Gels
• Inhalation: DPI and pMDI
• Special handling capabilities for hormones, potent and cytotoxic compounds and DEA controlled substances (Schedules I-V)

Formulate for Success

Pii offers a comprehensive portfolio of drug delivery solutions under one roof. Our diverse offerings allow us to address each compound's specific needs and challenges. From conventional tablets and capsules, to softgels and liquid/lipid filled hard gel capsules, Pii has the tools you need to formulate your compound for success. And with more than 400 development programs under our belt, Pii has extensive experience formulating difficult compounds with a variety of physiochemical characteristics.

Analytical Characterization of Materials

In addition to having the right processing capabilities, analytical characterization of the compound and drug product is an essential part to determining the appropriate technology, refining processing conditions and monitoring the stability of the product overtime. Pii offers a complete range of in-house analytical and solid state screening capabilities, including:

• Salt Screening and Selection
• Polymorph Screening
• Amorphous Content Quantification
• Hyper DSC
• Gravimtric Vapour Sorption
• Raman Spectroscopy
• XRD
• Stability Testing

About Pii:

Pharmaceutics International, Inc. (Pii) is a privately held contract development and manufacturing company providing dosage form development and GMP manufacturing services to the global pharmaceutical industry. Pii's vision is to become the benchmark in pharmaceutical product development and commercial manufacturing outsourcing. Headquartered in Hunt Valley, Maryland USA with European facilities in the UK, Pii offers preformulation testing, formulation development, clinical and commercial GMP manufacturing of solid, parenteral, inhalation, semi-solid and liquid dosage forms.

Meet with us at the show!
Tell us your manufacturing needs and see what Pii can do for you. Contact us today to schedule a meeting at your facility, Pii or one of the following conferences:

If using the Interphex Outsourcing One-on-One partnering program, be sure to check Pii from the list of exhibitors.

10819 GILROY ROAD, HUNT VALLEY, MD 21031 | T: (410) 584-0001 | F: (410) 584-0007
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