Aptar Pharma announces that the recent approval by the National Medical Products Administration (NMPA) in China of Sinomune Pharmaceutical’s Li Fu (丽芙) metronidazole gel for the treatment of papulopustular rosacea uses Aptar Pharma’s Mezzo+ CS (China Support) Airless dispensing solution for dermal drug delivery.
This approval marks the first Aptar Pharma Airless+ drug delivery system used for an approved drug product in China and re-confirms Aptar Pharma’s expertise in developing and supporting innovative drug delivery solutions worldwide.
About Papulopustular Rosacea
Papulopustular rosacea, a form of rosacea (sub-type 2), is an inflammatory dermatosis associated with papules or pustules, that primarily affects the central face. It is a chronic disease which can cause acne-like breakouts and can have an adverse impact on the patient’s quality of life. Rosacea is highly prevalent globally, with an estimated 3.5% of the population in China suffering from this skin condition.
Airless+ Dermal Drug Delivery Systems Meet Pharma Requirements
Designed to meet the increasingly strict regulatory and pharmaceutical demands for drug dispensing systems, Aptar Pharma’s Airless+ Drug Delivery Systems are made from medical grade resins that come with up-to-date change control management and support, mitigating risk from changes in manufacturing processes and materials.
Aptar Pharma’s portfolio of Airless+ Dermal Drug Delivery Systems combines advanced ergonomic design with user convenience for dispensing a wide range of viscosities. The Airless+ technology offers several benefits, including reliable dispensing in any position, as well as clean and reliable dosing, and minimized product wastage.
Part of Aptar Pharma’s Airless+ portfolio, the Mezzo+ CS dispensing solution includes dedicated support to the Chinese market.
Aptar Pharma holds a Status A pharmaceutical packaging material dossier for its Mezzo+ CS with the Center for Drug Evaluation (CDE), which has passed technical reviews for meeting the relevant regulatory requirements for pharmaceutical primary packaging in China.
“With this approval, we are happy to be expanding the reach of our proven Airless+ drug delivery technology to the China market,” said Dr. Stefan Hellbardt, Vice President Business Development and Scientific Affairs, Consumer Healthcare at Aptar Pharma. “Aptar Pharma’s proven Airless+ technology not only provides better protection for drug contents, but also gives patients a more convenient user experience.”
Xin Yao, China President and Vice President & General Manager of Aptar Pharma, NEA, commented, “We are pleased that our Aptar Pharma Airless+ technology is now available to patients in China who suffer from papulopustular rosacea.” She added, “This first approval in the region using our Mezzo+ CS solution demonstrates both the value of our dedicated regulatory support and the continued market opportunities in China and beyond for Aptar Pharma in dermal drug delivery.”
Hongwei Xie, CEO of Sinomune Pharmaceutical, said, “Aptar Pharma’s dedicated China Support ensured an accelerated and successful submission to the China NMPA for our newly packaged Li Fu metronidazole gel.” He added, “Delivered using Aptar Pharma’s metered Airless+ pump, our newly packaged Li Fu product offers added safety and convenience of use to patients suffering from papulopustular rosacea.”
Read full Press Release on Aptar Pharma’s first Airless+ approval in China here.
