Commercial Manufacturing

Now in our tenth year in business, PII has over 6 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), soft and hard gelatin capsules and semi-solid products.

Our cGMP facility is capable of manufacturing and packaging a wide variety of dosage forms for commercial manufacturing. The facility includes 36 manufacturing suites including 14 containment rooms for controlled manufacturing. These rooms are suitable for the manufacture of solids, liquids, semi-solids, liquid-filled hard gelatin capsules and soft gelatin capsules. The facility has been through several FDA inspections, the most recent in May 2006; documentation is available upon request.

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.  
 
Containment Suite Drugs Requiring Special Handling
 
Our manufacturing personnel are specifically trained to work with drugs that require special handling procedures. PII has 14 state-of-the-art containment suites for product manufacturing.

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.

Pharmaceutics International, Inc.
10819 Gilroy Road, Hunt Valley, MD 21031
Phone: 410 584-0001 Fax: 410 584-0007
www.pharm-int.com
Mission Statement: To deliver a quality dosage form development service which meets all of our customers’ needs in a timely fashion