Aptar Pharma adds Schedule II and III controlled-substance capabilities in Boonton
- The Boonton, New Jersey, facility is registered to handle, store, manufacture and test Schedule II and III controlled substances.
- The registration builds on the site’s existing high-potency handling capabilities.
- Services include formulation development, GMP clinical trial manufacturing, analytical testing, stability studies, fill-finish and regulatory support for orally inhaled and nasal products.
- The FDA-inspected facility offers integrated CMC and early clinical supply services.
Expanded controlled-substance capabilities
Aptar Pharma’s Boonton, New Jersey, formulation, fill and finish facility has received controlled substances registration authorizing the handling, storage, manufacturing and testing of Schedule II and III substances. This complements the site’s existing high-potency handling capabilities.
Development and clinical supply services
The FDA-inspected clinical trial materials facility offers integrated chemistry, manufacturing and controls (CMC) and early clinical supply services for controlled-substance therapies, including products for central nervous system conditions and pain management. Support for orally inhaled and nasal drug products includes formulation development, technology transfer, GMP clinical trial materials manufacturing, analytical testing, stability studies, fill-finish services and regulatory support.
The site’s capabilities can be combined with Aptar Pharma drug delivery device technologies. The facility has previously handled controlled substances across several dosage forms.
Source: Aptar