Dermal drug product for papulopustular rosacea approved in China

Published: 11-Apr-2024

The approval brings the product to the Chinese market, where 3.5% of the population suffer from the skin condition

Aptar Pharma, a global organisation specialising in drug delivery systems, services and active material science solutions, has announced the recent approval by the National Medical Products Administration (NMPA) of Sinomune Pharmaceutical’s Li Fu (丽芙) metronidazole gel for the treatment of papulopustular rosacea.

This approval marks the first Aptar Pharma Airless+ drug delivery system used for an approved drug product in China.

 

What is papulopustular rosacea?

Papulopustular rosacea, a form of rosacea (sub-type 21), is an inflammatory dermatosis associated with papules or pustules that primarily affects the face. It's a chronic disease which causes 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 condition1.

 

Meeting pharma requirements

Designed to meet the increasingly strict regulatory 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 minimised product wastage.

Part of Aptar Pharma’s Airless+ portfolio, the Mezzo+ CS dispensing solution includes dedicated support to the Chinese market.

“With this approval, we are happy to be expanding the reach of our proven Airless+ drug delivery technology to the Chinese 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.”

 

Bibliography

1 Zuo Z, Wang B, Shen M, et al. Skincare habits and rosacea in 3439 Chinese adolescents: a university-based cross-sectional study. Acta Derm Venereol. 2020;100(6):adv00081. doi:10.2340/00015555-3442

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