Guayama Manufacturing Site Overview

Historically, the Guayama site has produced a range of oral dosage forms, including products requiring high containment, controlled substances, hormonals, spheroids and a variety of specialty products.  The unique capabilities of this facility are associated with its high containment technology, the substantial capacity that is in place and its ability to meet the stringent requirements of the DEA with respect to the processing of controlled substances. 

The original building was built in 1966.The facility is built on land leased from the government (SIDCO).There are two major operations at the site—Pfizer Pharmaceuticals and Pfizer Consumer Health.  Some of the infrastructure is shared by the plants, and the system of allocations for the distribution of infrastructure cost are well documented.

The site was first operated by American Home Products in 1983.The main building was commissioned in 1984.In 1999 there was a management integration of Pharma and Consumer which was desegregated in 2003.In 2000 the Generics exited the site.  Also in 1990 a suppositories plant was added.  Over the years the plant has been expanded for introduction of new products.  In 2009 the PAT technology platform was approved by the FDA.
The Guayama site offers multiple drug product capabilities:

• Isolation technologies for Hi-potent compounds
• High level of automated modules with full integration from equipment, human interface and electronic batch record and MRP systems
• Spheroids, solvent coating & encapsulation
• Wet & dry granulation
• Hormone manufacturing isolated module
• High speed bottles & blister packaging lines
• Active Product Ingredient (API) Coating
• Process Analytical Technology (PAT) capabilities