IPURE successfully submitted TPMF and obtained FDA STN code

Strengthening the global compliance foundation and enabling Chinese brands to go global with high quality

Recently, IPURE officially submitted the Tobacco Product Master File (TPMF) to the U.S. Food and Drug Administration (FDA) and successfully obtained the STN code (Submission Tracking Number). This important milestone marks a key breakthrough in the construction of the global electronic atomization product compliance system by IPURE, providing industry customers with more efficient and professional compliance solutions to expand into the U.S. market.

TPMF: A technical “bridge” linking the international market

TPMF is one of the tobacco product compliance information systems established by the FDA. Companies can centrally register the formula structure, raw material source, toxicological data, production process and quality control system of the atomizer liquid, and authorize the brand owner to quote the STN number in the PMTA application.

Compared with the traditional path of brands submitting complex materials independently, TPMF has greatly improved the efficiency of PMTA review and is the "standard channel" for global raw material companies to enter the US market.

Strength builds professional barriers: IPURE's systematic compliance capabilities

As one of China's leading electronic atomization technology companies, IPURE has long been focused on the research and development, testing and global regulatory research of atomization liquid products, and has built a complete technology ecosystem covering the upstream, midstream and downstream.

The company has multiple advantages in compliance, technology and manufacturing:

1. Scientific research and development system

A senior perfumer team with more than 15 years of experience, who is familiar with the flavor preferences of markets in Europe, America, the Middle East, and Southeast Asia

Establish an independent flavor laboratory and recipe database to achieve rapid iteration and customized development

Accurately adapt to the US PMTA and EU TPD regulatory framework to ensure both formulation stability and toxicological compliance, and help global market access

II. International Regulatory Compliance Capabilities

Continue to track policy changes in multiple markets including the US FDA, EU TPD, UK MHRA, and Southeast Asia

可为客户提供PMTA注册辅导、技术资料准备、TPMF引用指导等全流程合规服务

成功服务多家客户完成欧盟TPD备案、中东ECAS注册等跨境准入事项

3. Manufacturing and supply chain service capabilities

The capacity of atomized liquid barrels exceeds 1,500 tons/month, supporting OEM/ODM customization and flexible supply of bottles/barrels

The factory environment complies with GMP standards and has a food-grade clean filling workshop

The full-process ERP management system supports full-process tracking and quality control from ordering, production to logistics

Obtaining STN code: Helping customers comply with regulations “one step faster”

STN (Submission Tracking Number) is the official tracking number issued by the FDA for TPMF, which means that the document has entered the US regulatory system and can be officially cited.

Brand owners can directly use the STN number provided by AIPU in their PMTA applications:

Reduce the amount of data preparation and improve efficiency

Reduce the risk of duplicate submissions and logical errors

Accelerate the PMTA approval process and seize the market opportunity

For Chinese e-cigarette brands that are planning to expand into the United States, choosing to cooperate with suppliers with TPMF filing capabilities will become a core "accelerator" for future competition.

Conclusion: Establish yourself with standards and go global with compliance

The e-cigarette industry is accelerating towards a compliance-driven development track. Compliance is not only a ticket to enter overseas markets, but also an important yardstick for measuring the degree of specialization and international vision of enterprises.

IPURE will continue to focus on technology and be regulated, providing customers with one-stop services from TPMF filing, PMTA registration, ingredient compliance, testing and verification to customized exports, and work with Chinese brands to go global with high quality.

If you need to obtain TPMF STN number quotation authorization or learn about the full process of PMTA services, please contact our professional compliance consultant team.

来源：IPURE艾普

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