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

Year Founded: 1994
Number of Employees: 250
Key Personnel: John Fowler, President & CEO
Business Development Team: Christian Ahlmark, Vice President of Business Development; Gerri Mirkin, Director of Business Development, East Coast; Cindy Koonce, Director of Business Development, Mid Atlantic; and Brad Arnold, Director of Business Development, West Coast
Human Resources: George Sanders, Vice President of Human Resources
R&D: Sundeep Sethia, Head of R&D
Quality: Thomas Pamukcoglu, Vice President of Quality
Quality Control: Cathy Sioma, Director of QC Analytical Services
Supply Chain: David Fidler, Senior Director of Supply Chain
Operations: Alan Saidel, Head of Operations
Project Management: Devan Patel, Senior Director of Business Development; Stephanie Taylor, Senior Project, Project Development; and Tobie McQueen, Project Coordinator
Marketing: Devan Patel, Senior Director of Business Development, and Paul Dupont, Head of Digital Marketing

 

Concept to Clinic to Commercialization

At Pharmaceutics International, Inc. (Pii), our motto is “challenges frame opportunities.” We are a US-based contract development and manufacturing organization (CDMO) that has a passion for solving problems efficiently with the highest quality standards. Emphasizing a collaborative relationship with our clients, Pii’s experts embrace the art and science of drug development and manufacturing. Our outcome is to deliver better results faster for our clients and their patients.

Pii’s Hunt Valley, Maryland campus includes four cGMP and FDA certified facilities, 70 manufacturing suites with all the necessary analytical testing capabilities on site, and four integrated aseptic filling suites delivering quality, safety, and efficiency.

Experienced with small and large molecule compounds, we have special expertise in developing and manufacturing complex parenteral drugs, vaccines, extended-release formulations, and non-aqueous injectable drug products. We can also overcome stability challenges with precision lyophilization cycle development and production.

Services
Formulation and Process Development
Oral Drug Development
Parenteral Drug Development
Bioavailability Enhancements
Method Development and Validation
Stability Testing
Clinical Trial Manufacturing
Commercial Manufacturing
Highly Potent Drug Manufacturing
Analytical Services
Quality Systems Development

Capabilities 
Development and Commercial Technology Transfer
Vaccine Fill/Finish
Sterile – vials, syringes, cartridges
Lyophilization
Highly Potent Compounds — hormones, cytotoxins
Parenterals — aqueous, non-aqueous
Oral Solids — soft gels, tablets, capsules
Oral Liquids — suspensions, syrups, solutions
Solid dispersions
Topicals
Controlled release formulations
Fluid-bed processing
Micro and nanotechnologies
Coating
Packaging Serialization
Enhanced Project Management

Pharmaceutics International Inc. (Pii) proudly offers a library of e-books for Bio/Pharma scientists. The series of e-books is ideal for Bio/Pharma companies seeking to partner with a Contract Development and Manufacturing Organization, such as Pii, and bring a molecule from clinic to commercialization. Using state-of-the-art specialized equipment, Pii offers phase-appropriate development in early stages to support your program and accelerate timelines. In these e-books, you will learn that partnering with a CDMO garners success when dealing with the following: Aseptic Manufacturing, Sterile Fill & Finish, Lyophilization Cycle Development, Scale-Up & Tech Transfer, HPAPI; Controlled Drugs/DEA Scheduled Drugs, BCS Class II to IV Drugs, Oxygen-Sensitive Drugs and Regulatory Hurdles.

Don’t delay in connecting with Pii’s R&D team! Download an e-book from the Pii library!

VIEW OUR RESOURCE CENTER WITH RELEVANT ARTICLES & VIDEOS

https://www.pharm-int.com/resources/

FORMULATION & PROCESS DEVELOPMENT

Drug Formulation & Process Development
https://www.pharm-int.com/formulation-process-development/

ASEPTIC DRUG DEVELOPMENT

Aseptic Manufacturing, Fill/Finish & Sterilization
https://www.pharm-int.com/formulation-process-development/parenteral-drug-development/aseptic-filling/

Aseptic Manufacturing & Sterile Fill/Finish Resource Center
https://www.pharm-int.com/aseptic-manufacturing-and-sterile-fill-finish/

Aseptic Manufacturing FAQs
https://www.pharm-int.com/aseptic-manufacturing-and-sterile-fill-finish/aseptic-filling-faq/

Tech-Drive Lyophilization Cycle Development & Optimization
https://www.pharm-int.com/formulation-process-development/parenteral-drug-development/lyophilization/

Parenteral Drug Formulation, Process Development & Fill/Finish
https://www.pharm-int.com/formulation-process-development/parenteral-drug-development/

ORAL DOSE DRUG DEVELOPMENT

Oral Dose Development Expertise
https://www.pharm-int.com/formulation-process-development/oral-drug-development/

Oral Dose Resource Center
https://www.pharm-int.com/oral-drug-resource-center/

Soft Gel Capsules & Liquid-Filled Hard Shell (LFHS) Manufacturing
https://www.pharm-int.com/formulation-process-development/oral-drug-development/soft-gels/

THE ART & SCIENCE OF TECH TRANSFER

Tech Transfer: Reducing Risks, Increase Efficiency & Deliver Reliability
https://www.pharm-int.com/tech-transfer/

Vaccine Fill/Finish Tech Transfer
https://www.pharm-int.com/tech-transfer/commercial-manufacturing/vaccine-tech-transfer/

Commercial Manufacturing
https://www.pharm-int.com/tech-transfer/commercial-manufacturing/