Aptar Pharma Adds Controlled Substance Capabilities at New Jersey Facility
Key Points
- Aptar Pharma's Boonton, New Jersey facility received DEA registration to handle Schedule II and III controlled substances
- The site will support development to clinical manufacturing for controlled substance-based inhaled and nasal therapies
- The FDA-inspected facility offers integrated CMC, formulation, analytical, stability, fill-finish and regulatory services for OINDPs
Aptar Pharma has expanded its contract development and manufacturing capabilities with a new Drug Enforcement Administration (DEA) registration authorizing its Boonton, New Jersey, facility to handle Schedule II and III controlled substances. The expanded registration positions Aptar Pharma Services to provide development-to-clinical manufacturing support for companies pursuing controlled substance-based inhaled and nasal therapies.
The authorization covers the storage, handling, manufacturing and testing of controlled substances, adding to the site’s existing high-potency compound capabilities. The expansion strengthens Aptar Pharma Services’ ability to support pharmaceutical companies developing complex drug products, particularly those targeting central nervous system (CNS) disorders, pain management and other specialty therapeutic areas.
The FDA-inspected facility provides an integrated range of chemistry, manufacturing and controls (CMC) services, along with early-stage clinical supply support. Its capabilities span formulation development, technology transfer, good manufacturing practice (GMP) clinical trial material production, analytical testing, stability studies, fill-finish operations and regulatory support for orally inhaled and nasal drug products (OINDPs).
By bringing these services together at a single site, Aptar aims to simplify the development process for customers working on controlled substance formulations. The model also gives drug developers access to Aptar’s drug delivery device technologies, potentially reducing the need to coordinate multiple external suppliers as programs move toward clinical evaluation.
“Adding Schedule II-III controlled substance capabilities is another step in building a comprehensive development and manufacturing platform for inhaled and nasal drug products,” says Valerie Otte, director of business development for Aptar Pharma Services. She noted that the expanded offering is intended to help customers advance complex formulations through development and into clinical testing.
According to Dr. Paul Shields, site director at the Boonton facility, the site has prior experience handling controlled substances in multiple dosage forms. That operational background, he said, provides a foundation for supporting additional customer programs while maintaining established quality, regulatory compliance and security standards.
Visit www.aptar.com for more information.
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