On June 24, Nanjing Heron Pharmaceutical Co., Ltd. (hereinafter referred to as “Heron Pharma”), a wholly-owned subsidiary of Nanjing Heron Pharmaceutical Science and Technology Co., Ltd. (hereinafter referred to as “the Company”), obtained the official GMP Inspection Report issued by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). The document formally confirms that Heron Pharma’s API Tacalcitol has successfully passed PMDA’s on-site GMP compliance audit.
As one of the three founding members of ICH, Japan has long been known for its stringent and high-standard pharmaceutical regulatory system.Heron Pharma has undergone a comprehensive PMDA on‑site audit covering the entire quality system, including quality, production, facilities and equipment, laboratory controls, materials, and packaging and labeling.
Tacalcitol is a synthetic vitamin D3 derivative that effectively modulates the proliferation and differentiation of keratinocytes, while also offering favorable immunomodulatory properties.Clinically, it is widely indicated for the treatment of psoriasis vulgaris and is also applied as an adjuvant therapy for vitiligo.
In 2021, the Company’s Tacalcitol Ointment (海芙润®) was granted marketing approval by China’s National Medical Products Administration, making it the first generic drug of its kind to launch in the Chinese market.
Adhering to an innovation-driven development philosophy and a differentiated product competition strategy, Heron Pharma specializes in the R&D and manufacturing of vitamin D derivative pharmaceuticals. The Company has established a robust R&D pipeline spanning innovative drugs, modified new drugs and high-end generic drugs across five key therapeutic fields: analgesia, dermatology, orthopedics, nephrology and anti-infection. By building differentiated technical platforms and a diversified product portfolio, the Company aims to become a globally leading supplier of active vitamin D (calcitriol) drugs and a trusted provider of professional pain management solutions. We are dedicated to providing better therapeutic drugs for patients and enhancing the value to life.
The successful completion of this GMP inspection marks a significant leap forward in the Company’s international quality management system, laying a solid foundation for the global market expansion of Tacalcitol and our entire product portfolio. Moving forward, the Company will seize this opportunity to further consolidate and enhance our brand reputation and core competitiveness in the international active pharmaceutical API sector.
Going forward, the Company will continue to refine and elevate its quality management system in line with international high standards to safeguard patient health. This continuous optimization will further support the global and domestic market expansion of the Company’s high-quality pharmaceutical products.
Post time: Jul-31-2026