NMPA CDE Excipient Filing F20260000425: A Rare Regulatory Milestone for MCT Oil

Pharmaceutical buyers ask us one question more than any other: "Can your MCT oil be used in a registered drug product?" As of this year, our answer carries official weight. Medium-chain triglycerides (MCT) produced by Shandong Nametai Biotechnology Co., Ltd. are now listed with an active filing on the pharmaceutical excipient filing platform of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) — filing number F20260000425, status Active (已激活), most recently updated on 21 August 2026.

Among domestic MCT oil producers, filings of this kind remain rare. In this post we explain what the excipient filing system is, what "active" status actually means, and — most importantly — what it changes for you as a buyer sourcing MCT oil for pharmaceutical and nutraceutical applications.

What the CDE excipient filing system is

China reformed its drug regulation framework with the introduction of the marketing authorization holder (MAH) system and the associated review and approval process (关联审评审批). Under this regime, pharmaceutical excipients are no longer registered as standalone approvals. Instead, manufacturers file their product's manufacturing description, quality standards and stability data on the CDE's public excipient filing platform, and the filing is then reviewed in association with the drug products that reference it.

The platform is public. Anyone can search it by company name, product name or filing number — the screenshot in this post is taken directly from the official NMPA CDE website. Each record shows the filer, the product name and source, packaging specifications, the update date and, critically, the status flag: "A" (active) or "I" (inactive). An active filing means the submitted dossier is complete and available for drug applicants to cite; an inactive one has been withdrawn, replaced or failed completion checks.

Readers familiar with the United States system can think of it as functionally comparable to a Drug Master File (DMF): the supplier's technical dossier sits on file with the regulator, ready to be associated with a customer's drug application without the supplier having to disclose confidential manufacturing details to the customer.

What is in our filing

The public record for F20260000425 covers medium-chain triglycerides manufactured at our production base in the Yellow River Delta Agricultural High-tech Industrial Demonstration Zone, Dongying, Shandong. The listed packaging options are 150 kg drums, 20 kg drums, 190 kg drums and customer-supplied packaging. The filing sits on top of the quality infrastructure we have described in earlier posts: specification panels aligned with the Chinese pharmacopoeia requirements for MCT, batch-level testing on an Agilent 7890B GC system, and third-party verification. Our pharmaceutical grade MCT oil page lists the full parameter panel — relative density 0.93–0.96, refractive index 1.440–1.452, viscosity 25–33 mPa·s, acid value ≤0.2, and fatty acid composition C8 50–80% / C10 20–50%, among others.

Why active excipient filings are rare among MCT producers

Filing a pharmaceutical excipient dossier is a serious commitment of engineering and documentation effort. The regulator expects a defensible description of the manufacturing process, validated analytical methods, stability data across storage conditions, and a quality management system able to support GMP-style change control. Many MCT producers in China serve the food and cosmetic sectors profitably and never make this investment — which is precisely why the food-grade and pharmaceutical-grade markets remain sharply separated. An active filing is the visible line between the two.

What it means for pharmaceutical and nutraceutical buyers

If you formulate drugs, or nutraceuticals positioning on pharma-grade raw materials, an active excipient filing changes your sourcing math in four concrete ways:

• Regulatory pathway. For drug products registered in China, your MAH application can reference an existing active filing instead of building a bespoke justification for an unregistered excipient — saving review cycles and reducing approval risk.
• Audit trail. The filing gives your QA team an official, verifiable record of who manufactures the material, where, and under what packaging options — cross-checkable against the COA we ship with every batch.
• Supplier qualification leverage. Your internal quality committee can approve the source faster when a regulator-listed dossier exists; the same logic international buyers apply to US DMFs and EU CEPs applies here.
• Continuity signal. Maintaining an active filing — ours was updated on 21 August 2026 — obliges the manufacturer to keep documentation current through process and site changes. It is a standing commitment, not a one-off certificate.

One honest caveat: a filing is an activation, not a product-specific approval. The excipient dossier is reviewed in association with each drug application that cites it, and your formulation, route of administration and specification fit remain subject to review. What the filing guarantees is that a complete, regulator-held dossier exists and is available — which is exactly the stage most MCT suppliers in China never reach.

For buyers mapping the China market, the practical screening step is simple: search the CDE excipient platform by product name and check the status flag. An active entry tells you the supplier has cleared the documentation bar; silence tells you the pharmaceutical story ends at the marketing brochure. It costs nothing, takes minutes, and filters out more risk than any certificate wall.

How we work with pharma customers

For projects that reference our filing, we support the association review with batch COAs, chromatograms, stability documentation and — where needed — site audit access, following the same routine we describe in our pharma-grade versus food-grade comparison. Samples ship in 20 kg pails; production lots in 150 kg or 190 kg drums; and custom C8:C10 ratios can be qualified with measured data before scale-up. To request the filing reference details for your regulatory dossier or to arrange an audit, contact our sales team.