On July 3, 2026, WeCaps Hypromellose Empty Capsules (Registration No.: F20200000114) officially passed the National CDE Associated Joint Review and Approval, with a compliance grade of Class A, and can be compliantly used in the production of marketed pharmaceuticals and health food products!

✅ Official Announcement | Qualification Upgrade, Compliance Strength

Recently, the Center for Drug Evaluation (CDE) of the National Medical Products Administration announced that Hypromellose Empty Capsules (Registration No.: F20200000114) have successfully completed the associated joint review and approval with drug preparations. Effective July 3, 2026, the registration status is officially Class A.

This represents the authoritative recognition of our product quality, production processes, and safety stability by the national drug regulatory authority, and marks that WeCaps plant-based empty capsules have entered the highest compliance level, providing more reliable and worry-free excipient supporting services for pharmaceutical and health food enterprises.

✅ In-Depth Analysis | How Significant is Class A Qualification?

Many enterprises struggle with the difference between Class A and Class I during excipient selection, drug registration, and consistency evaluation. The two differ significantly in compliance level and registration value:

✅ Class A (Approved Qualification · Highest Compliance Level)

Officially certified by CDE, having fully passed the associated joint review and approval with preparations — an authoritative endorsement of pharmaceutical excipient compliance.

• Wide application scope: Fully meets the marketing and production qualification requirements for marketed drugs, innovative drugs, generic drugs, traditional Chinese medicine preparations, and health food products;

• High registration efficiency: When enterprises apply for drug registration, changes, or consistency evaluation, they can directly reference official registration data without repeating excipient verification studies, significantly shortening the registration cycle and reducing the risk of supplementary materials;

• Zero inspection risk: All dimensions — process, quality, stability, and safety — have passed official verification. Full traceability is ensured throughout unannounced inspections, audits, and sampling tests, with compliance guaranteed.

⚠️ Class I (General Registration Status)

Only basic information registration has been completed, without passing the associated review with preparations. The compliance level is far lower than Class A. When enterprises use such excipients for project registration, they need to supplement extensive research data, resulting in cumbersome procedures and high approval uncertainty, which can easily impact project progress.

✅ Quality Foundation | High Standards Build Class A Strength

This Class A qualification is no accident — it is the inevitable result of WeCaps' long-term commitment to high-quality production control and a rigorous quality system. Our Hypromellose Empty Capsules (HPMC Plant Capsules) possess multiple core advantages, adapting to various high-end preparation needs:

• Pure plant source, safe and worry-free

  Made from plant cellulose raw materials, free of animal gelatin, animal-derived risks, allergens, and epidemic hazards. Suitable for vegetarian populations and multi-religious markets, with smooth export compliance both domestically and internationally.

• Excellent chemical inertness, compatible with a broad spectrum of drugs

  Contains no amino acids, eliminating the Maillard reaction. Does not react with acidic, reducing, or easily degradable active pharmaceutical ingredients, effectively preventing drug discoloration and degradation, and significantly extending preparation shelf life.

• Low moisture characteristics, suitable for sensitive materials

  Low shell moisture content and stable toughness, perfectly suited for sensitive contents such as traditional Chinese medicine extracts, probiotics, antibiotics, and hygroscopic powders. Stable filling on machines, resistant to brittleness, cracking, and deformation during storage.

• Multi-pharmacopoeia compliance, dual-track versatility

  Complies with the Chinese Pharmacopoeia, and has obtained DMF, FDA, HALAL, KOSHER and other certifications, simultaneously meeting the production and registration requirements of both pharmaceutical and health food tracks.

✅ Value Empowerment | Comprehensive Support for Product R&D and Launch

The official implementation of Class A qualification will bring tangible cost reduction, efficiency improvement, and compliance guarantees to partner enterprises, thoroughly solving the registration pain points of excipient selection:

• Cost reduction and speed-up: Eliminates the cost of repeated excipient research, testing, and verification, streamlines the drug registration process, and accelerates project launch progress;

• Risk mitigation: Official Class A registration status is publicly verifiable with full traceability, easily coping with regulatory unannounced inspections and customer audits;

• One material, multiple uses: One set of excipient qualifications covers the R&D and production of chemical drugs, traditional Chinese medicine, biological drugs, and health food products, simplifying supply chain management.

Official Product Filing Information (Publicly Verifiable)

• Product Name: Hypromellose Empty Capsules

• CDE Pharmaceutical Excipient Registration No.: F20200000114

• Qualification Effective Date: July 3, 2026

• Review Status: Class A (Passed Joint Review and Approval with Preparations)

• Application Scope: Marketed pharmaceuticals, various health food products

Conclusion

Qualification upgraded, quality unchanged! This successful Class A qualification is not only a high recognition of WeCaps' product strength by the industry, but also our responsibility and confidence in deeply cultivating the pharmaceutical excipient industry.

Going forward, WeCaps will continue to adhere to GMP production standards, refine production processes, and improve the quality control system. With national-level compliance standards, we will provide safer, more stable, and more compliant plant capsule solutions for global pharmaceutical and health product enterprises, helping customers achieve efficient project registration and product launch!