Aptar Pharma's Obtains Import Licence in China

Aptar Pharma has obtained a State Food and Drug Administration (SFDA) import licence approval to deliver its preservative-free multi-dose systems to customers in China.The licence approval represents a further step in Aptar Pharma’s ongoing service development to provide large-scale production services to customers, mainly for its Ophthalmic Squeeze Dispenser (OSD) and its Advanced Preservative Free spray pump (APF).

Aptar Pharma Enlarges its Service Scope in China

In China, the pharmaceutical sector remains dynamic, outpacing growth in developed countries. The import of packaging materials for pharmaceutical products requires an “Examination and approval for packaging materials and containers in direct contact with drugs” from the SFDA before being placed on the market. Now that this import licence approval has been granted for the Ophthalmic Squeeze Dispenser (OSD) and Advanced Preservative-Free Systems (APF), pharmaceutical and biotechnology companies can directly import Aptar Pharma’s preservative-free multi-dose systems into the Chinese market. The OSD is manufactured in a class ISO 7 cleanroom at the Aptar Pharma state-of-the-art production facility in Eingeltingen, Germany.

Preservative-Free Systems are Key to Drug Manufacturers

Preservative-free systems are highly appreciated by patients who experience side effects from preservatives like benzalkonium chloride during chronic use. The APF spray pumps and the OSD systems follow a purely mechanical approach to prevent contamination via the orifice. The applied technology is referred to as “tip seal technology” and well established on other markets.

A key element of Aptar Pharma’s preservative-free technology is a spring-loaded tip seal that keeps the system closed until a defined pressure is reached during actuation and the formulation is dispensed through the orifice. When the pressure drops consequently, the tip seal immediately closes the orifice by an outward movement, which prevents any back-flow of contaminated liquids or particles. 

For the venting air, Aptar Pharma uses a sterile filter to stop micro-organisms from entering. The fluid path of these systems is “metal-free”, which means the springs needed for the device operation do not come in contact with the formulation. The technology is widely established and market proven in both nasal and ophthalmic applications.

In addition, the APF spray pumps and the OSD systems are designed to be patient-friendly and easy to use to help improve patient compliance with the medical treatment. The 360° functionality of the APF spray pumps ensures convenient and safe handling; especially for pediatric use. Aptar Pharma’s OSD system is engineered for intuitive handling, smooth actuation and precise and reproducible dosage, all this with pocket sized design.

Aptar Pharma Established in China Since 1996

The import license will help meet market demand in China and further establishes Aptar Pharma’s presence in China, through its production site in Suzhou, near Shanghai. Aptar Pharma Suzhou was established in 1996 and produces pMDI metering valves and spray pumps for the Asian market. The site serves the majority of the local Chinese pharmaceutical companies, whether they are producing drug products for the domestic market or for other Asian regions. 

“We are pleased to announce the import licence for the OSD technology and APF pump technology to China. 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”, said Matthias Birkhoff, Vice President Business Development for Aptar Pharma CHC Division.