Aptar Announces Clinical Validation Study to Accelerate US FDA Approval of SmartTrack™ In-Vitro-in-Silico Platform for Pressurized Metered-Dose Inhalers
AptarGroup, Inc. (ATR)
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Source: Business Wire
SmartTrack™ aims to reduce the need for clinical studies in generic drug product approvals CRYSTAL LAKE, Ill.--(BUSINESS WIRE)--AptarGroup, Inc. (NYSE: ATR), a global leader in drug and consumer product dosing, dispensing and protection technologies, today announces the commencement of a clinical study to validate its proprietary SmartTrack™ platform. The platform was developed by Aptar’s drug services company, Nanopharm. If validated, SmartTrack™ aims to reduce the need for clinical studies in generic drug product approvals by proving it can accurately predict clinical outcomes – removing a major barrier for pharma companies and regulators and paving the way for wider patient access to medications. This validation would establish SmartTrack™ as a credible in-vitro-in-silico alternative to comparative clinical endpoint (CCEP) studies, and a reliable approach to derisking in vitro-pharmacokinetic (PK) only approaches, specifically for generic inhaled drug products.This press release
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ATR
Earnings
- 10/30/25 - Beat
ATR
Sec Filings
- 12/15/25 - Form 4
- 12/12/25 - Form 144
- 11/20/25 - Form 8-K
- ATR's page on the SEC website