TAP Registration for Chinese Market Approved

TAP Registration for Chinese market is now approved. Ingredientpharm confirms the new Drug Master File (DMF) for TAP® meets Chinese Pharmacopoeia (ChP) regulations. This approval allows pharmaceutical companies to market formulations containing TAP® in one of the largest pharmaceutical markets in the world.

Significance of TAP registration for Chinese market

The registration gives manufacturers a faster route to enter China’s growing pharmaceutical industry. With ChP compliance, they can confidently use TAP® in new or existing drug formulations. As a result, companies gain access to a market with high demand for advanced excipients.

TAP® – A pelletized excipient with high performance

TAP® is made of 100% tartaric acid in pellet form. The pellets modify the local environment of the drug. This change greatly improves the solubility of BCS Class IV drugs. Moreover, TAP® comes in particle sizes from 100 µm to 1000 µm. It complies with Ph.Eur., USP/NF, JP/JPE, and ChP monographs.

Opportunities for pharmaceutical development in China

Thanks to the TAP Registration for Chinese market, companies can launch innovative products in China more easily. They also benefit from regulatory alignment with major pharmacopeias. Consequently, businesses can expand their presence in one of the fastest-growing pharmaceutical markets.

TAP® product details

Learn more about TAP® specifications, technical data, and regulatory information to support your next formulation project. See: product details

What are TAP® pellets and why they matter

TAP® stands for tartaric acid pellets, designed to create a localized acidic micro environment around active pharmaceutical ingredients (APIs), especially in the gastrointestinal tract. Structurally, TAP® is a functional starter core made entirely from tartaric acid—it contains no binders—and meets key pharmacopeia standards (Ph. Eur., USP/NF, JP, ChP).

How TAP® is used in formulations

TAP® pellets serve multiple critical purposes in pharmaceutical formulations:

pH modulation: By lowering the local pH upon dissolution, they help weakly basic drugs dissolve more efficiently in higher pH regions like the intestine.
Starter cores for pellet technologies: Their high sphericity and monodispersity make them ideal for layered, multiparticulate dosage forms, tablets, mini-tablets, MUPS (multiple-unit pellet systems), capsules, and sachets.
Controlled or extended release: When coated with polymers, TAP® cores help ensure consistent, predictable release profiles and reduce dose dumping risk.

Typical formulations that use TAP®

TAP® finds its place in formulations such as:

Multiparticulate systems like pellet-based capsules, mini-tablets, or sachets, where uniform particle size supports consistent layering and coating processes.
Extended-release oral solids, where the acidic core prevents reduced solubility in higher pH environments and allows for sustained API release.
Taste-masked dispersible tablets or granules, where TAP® helps control environment and coating integrity.

APIs that benefit from TAP®’s acidic micro environment

Weakly basic APIs, especially those with poor solubility at neutral or alkaline pH, demonstrate significantly improved dissolution and bioavailability when formulated with TAP®:

Verapamil HCl
Propiverine HCl
Papaverine
Dipyridamole
Dabigatran (likely dabigatran etexilate mesylate as a pro-drug)
Chloramphenicol (also noted in ingredientpharm sources).

These APIs dissolve better in acidic conditions, making TAP® a functional excipient for enabling consistent absorption and therapeutic effect.

Why formulators choose TAP®

Formulators opt for TAP® because it:

Enhances solubility of weakly basic APIs by creating a tailored acidic micro environment.
Simplifies manufacturing: Ready-made spherical tartaric acid cores avoid additional granulation or sub-coating steps.
Supports flexible dosage formats from mini-tablets to sachets to consistent multiparticulate blends.
Improves product performance: Better dissolution, controlled release, reduced variability, and higher compliance.