Aptar Pharma’s Nasal Device Approved by FDA for Breakthrough Treatment
Aptar Pharma recently announce that its Bidose nasal spray device was recently approved by the US FDA for a breakthrough therapy in the field of depression. This marks the first FDA approval and US launch of a prescription drug using Aptar Pharma’s patented Bidose nasal spray delivery system.
This approval again demonstrates Aptar Pharma’s expertise in developing patient-friendly drug delivery solutions for breakthrough medicines. Aptar Pharma offers a broad portfolio of innovative technologies and wide array of services to meet the highest quality standards of the pharmaceutical industry.
Ability to Build Long-Term Collaborative Partnerships
Aptar Pharma’s key to success is its ability to build effective partnerships with pharma customers to deploy complex projects requiring rigorous methodology and joint governance.
This customized Bidose liquid device is produced in Aptar Pharma’s state-of-the-art manufacturing facility in Congers, NY, which offers laboratory and other organizational capabilities to support nasal and injectable drug delivery systems.
Patented Bidose Technology Platform
Aptar Pharma’s Bidose liquid system is designed for local or systemic delivery of drugs. As a robust, primeless, intuitive and easy-to-use device with 360° functionality and precise spray characteristics, the Bidose system provides accurate two-shot nasal drug delivery.
The Aptar Pharma Bidose and Unidose systems offer biotech and pharmaceutical companies effective and reliable intra-nasal delivery platforms for a variety of medicines including potential life-saving treatments and treatments of severe conditions. This nasal product platform can enhance brand image via an elegant and intuitive design while limiting the volume of drug accessible to patients. The devices can also integrate wireless connectivity technologies.
Accelerated Development Support via Aptar Pharma Services
This breakthrough therapy approval is an example of a Combination Product, and benefited from Aptar Pharma’s Services offering, a comprehensive portfolio of stage-specific packages designed to proactively address regulatory needs to accelerate approval.
Leveraging its extensive value-adding capabilities including lab and analytical services, proven regulatory expertise – with dedicated Regulatory Affairs experts and fast approval data packages – and customized drug delivery solutions, Aptar Pharma’s Services can enable an expedited approval and launch in the competitive pharmaceutical space.
“We are pleased that Aptar Pharma’s Bidose nasal delivery device has been approved by the FDA for this breakthrough therapy in the field of depression,” explained Gael Touya, President, Aptar Pharma. “This project marks close to a 10-year customer collaboration and once again demonstrates Aptar Pharma’s ability to develop and launch complex drug delivery systems worldwide.”
About Aptar Pharma
Aptar Pharma is part of AptarGroup, Inc., a leading global supplier of a broad range of innovative dispensing, sealing and active packaging solutions for the beauty, personal care, home care, prescription drug, consumer health care, injectables, food and beverage markets.
Aptar uses insights, design, engineering and science to create innovative packaging technologies that build brand value for its customers, and, in turn, make a meaningful difference in the lives, looks, health and homes of people around the world. Aptar is headquartered in Crystal Lake, Illinois and has over 14,000 dedicated employees in 18 different countries. For more information, visit www.aptar.com/pharma.
+33 1 39 17 20 38
Total Page Views: 677