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Aptar Pharma gets SFDA nod for multidose systems

Source:Ringier Medical Release Date:2015-04-16 1449
Medical Equipment
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The approval paves the way for direct importation of the company’s OSD system and APF spray pump into China
APTAR Pharma has recently obtained a State Food and Drug Administration (SFDA) import license approval for its Ophthalmic Squeeze Dispenser (OSD) and Advanced Preservative-Free (APF) spray pump.
 
A milestone in the company’s service development efforts to provide large-scale production services to customers, the SFDA approval will allow Aptar Pharma to deliver preservative-free multidose systems to help meet demand in China and strengthen its presence in the country. It will enable pharmaceutical and biotechnology companies to directly import the firm’s preservative-free multidose systems into the Chinese market.    
 
Aptar Pharma Advanced Preservative-Free (APF) spray pumpPreservative-free systems benefit patients who experience side effects from preservatives such as benzalkonium chloride during chronic use. The OSD, which is manufactured in a class ISO 7 cleanroom at Aptar Pharma’s state-of-the-art production facility in Eingeltingen, Germany, and the APF spray pumps adopt the “tip seal technology,” a purely mechanical approach widely proven in both nasal and ophthalmic applications in preventing contamination through the orifice.  
 
This tip seal technology involves the use of a spring-loaded tip seal to keep the systems closed until a defined pressure is reached during actuation and the formulation is dispensed through the orifice. The tip seal closes the orifice with an outward movement when the pressure drops, preventing any backflow of contaminated liquids or particles. A sterile filter for the venting air blocks the entry of microorganisms.  The springs in the system do not come in contact with the formulation, making the fluid path “metal-free.” 
 
To improve patient compliance with the medical treatment, the preservative-free systems are designed to be patient-friendly and easy to use. The APF spray pumps feature 360-degree functionality for convenient and safe handling, in particular for pediatric use. The pocket-sized OSD system enables intuitive handling, smooth actuation, and precise and reproducible dosage.
 
Matthias Birkhoff, vice president of Business Development for Aptar Pharma CHC Division, said the company expects that the import license for the OSD and APF multidose systems to China will be marked by the success the technologies have had worldwide. "We have had tremendous success marketing these technologies in other regions of the world and we are confident that our customers and consumers in China will value the benefits of our preservative-free systems.  As with any of our technologies, we continue to invest in ways to even further improve our devices as we adapt to our customers’ future needs and expectations,” he said.
 
A global solution provider of innovative and proven aerosol, injection, and spray delivery systems for biotech, healthcare, and pharma products, Aptar Pharma was the first company licensed to manufacture spray and aerosol drug delivery devices for this market. It is one of the pioneers of local drug delivery systems manufacturing in China. Aptar Pharma Suzhou, established in 1996, produces pMDI metering valves and spray pumps for the Asian market. It serves the majority of the local Chinese pharmaceutical companies. 
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