KornnacCaps has successfully passed the US FDA's DMF (Drug Master File) filing, with the filing number being DMF#043237. This milestone marks a crucial step in KornnacCaps' internationalization process, as its products have officially entered the compliance sequence for US market access.
The DMF filing is a crucial mechanism by which the US FDA regulates key materials such as pharmaceutical excipients and active pharmaceutical ingredients (APIs). By filing the DMF, KornnacCaps submitted core data to the FDA regarding the production process, quality control methods, and facility and equipment descriptions of its KornnacCaps empty capsules. After a rigorous review of the DMF documents, the FDA confirmed that KornnacCaps' production system, quality management system, and product safety meet US regulatory requirements, thereby granting the DMF number. This means that KornnacCaps capsules can be used as legitimate excipients by US pharmaceutical companies in drug production, laying the foundation for subsequent dosage form products to enter the US market.
As a leading Chinese supplier of empty capsules, KornnacCaps has always positioned itself as a Service Provider of Functional Capsule. The company has established a quality management system in accordance with cGMP standards and has obtained international certifications such as HALAL, Kosher, ISO9001, and ISO22000, as well as EU registration. Its product line includes innovative products such as gelatin capsules, HPMC capsules, Halal capsules, Pullulan capsules, and enteric-coated capsules, and it possesses technical solutions that meet international regulatory requirements, such as being free from titanium dioxide and sodium dodecyl sulfate. Most importantly, KornnacCaps capsules do not use ethylene oxide for sterilization and do not contain preservatives, which better meets customers' personalized and innovative formulation needs.
The success of this DMF filing is not only an authoritative recognition of KornnacCaps' technical strength and quality management level but also an important achievement of its globalization strategy. Currently, KornnacCaps' products have reached the entire country and are exported to more than 20 countries and regions including Europe, the United States, Southeast Asia, and Africa. In 2024, the company relocated to a smart new park with a total investment of 1 billion yuan, and in 2025, it completed a brand upgrade, opening a new chapter in the market with a brand-new KornnacCaps image. In the future, KornnacCaps will continue to uphold the concept of innovation leadership, providing global customers with high-quality capsules and customized solutions, and creating a brilliant future together with customers.
