Aptar Pharma Expands Services Capabilities to Support Development of Inhaled and Nasal Drug Products Containing Controlled Substances

Aptar Pharma, a global leader in drug delivery, dosing, protection technologies and services, today announced that its state-of-the-art formulation, fill and finish services facility in Boonton, New Jersey, has been granted a controlled substances registration authorizing the handling, storage, manufacturing and testing of Schedule II and III controlled substances. The controlled substances registration complements the facility’s existing high-potency handling capabilities and further reinforces Aptar Pharma Services’ specialized support for complex pharmaceutical products.

Customers developing controlled substance therapies - including central nervous system (CNS), pain management and other specialty pharmaceutical products - can access integrated chemistry, manufacturing and controls (CMC) and early clinical supply services within a controlled and compliant environment.

Part of Aptar Pharma Services, this FDA-inspected clinical trial materials manufacturing facility allows customers to work with a single partner across formulation development, technology transfer, GMP clinical trial materials manufacturing, analytical testing, stability studies, fill-finish services and regulatory support for orally inhaled and nasal drug products (OINDPs).

By combining these services with Aptar Pharma’s drug delivery device technologies, the Boonton site can help customers streamline development, manufacturing and regulatory support to reduce the complexity of coordinating multiple external vendors and accelerate their progress to the clinic.

Valerie Otte, Director of Business Development, Aptar Pharma Services, said, “Our goal is to make it easier for customers to advance complex and innovative drug products into clinical development. Adding Schedule II-III controlled substance capabilities is another step in building a comprehensive development and manufacturing platform for inhaled and nasal drug products.”

Dr. Paul Shields, Site Director at Aptar Pharma’s Boonton site, added, “This facility has previously handled controlled substances across several dosage forms, so the controls and experience are already well-embedded in our operations. This puts us in a strong position to support a broader range of customer programs while maintaining the highest standards of quality, compliance and security.”

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