Excipients are treated as commodities and behave as functional ingredients. That gap is where formulations fail, and it is the reason this is a separate service rather than a footnote to API supply.
Pharmaceutical excipients are inactive ingredients that carry, bind, disintegrate, lubricate or coat a formulation. NJMC sources them by functional specification rather than by compendial name alone, because two materials meeting the same USP or Ph. Eur. monograph can behave differently in a blend. Categories covered include fillers, binders, disintegrants, lubricants, film coatings and solubilisers.
An excipient is bought by name and performs by grade. Two materials can carry the same compendial name, both fully compliant, and behave differently in your blend because the particle morphology, the moisture content or the degree of substitution differs. Buyers who treat excipients as commodities discover this during scale up, which is the most expensive possible moment.
We source excipients on the functional specification, not the name alone. That means asking what the material has to do in your formulation before asking who can supply it.
Lactose in its various grades, microcrystalline cellulose, mannitol, dibasic calcium phosphate, starches. Grade selection here drives compressibility and flow more than any other single choice.
Povidone, hypromellose, pregelatinised starch, hydroxypropyl cellulose. Viscosity grade matters, and it is the detail most often left off an enquiry.
Croscarmellose sodium, sodium starch glycolate, crospovidone. Superdisintegrant performance is sensitive to both level and distribution in the blend.
Magnesium stearate, stearic acid, sodium stearyl fumarate, colloidal silicon dioxide, talc. Magnesium stearate in particular varies meaningfully between sources in surface area and hydrate form.
Hypromellose, polyethylene glycols, titanium dioxide alternatives, enteric polymers where a delayed release profile is required.
Polysorbates, poloxamers, cyclodextrins, parabens and alternatives, along with capsule shell materials in gelatin and vegetarian hypromellose.
Why this is a separate page and not a line on the API page. Excipient buyers ask different questions from API buyers, and the failure modes are different. Treating the two as one category is exactly the habit that leads to an excipient being selected on price and a batch being reworked six months later.
An inactive ingredient in a formulation that performs a function such as filling, binding, disintegrating, lubricating, coating or solubilising. It is not therapeutically active but it determines whether the product manufactures and performs correctly.
Not usually. Compendial compliance is a minimum. Particle size, bulk and tapped density, moisture and surface area frequently sit outside the monograph and are often what decides performance in your blend.
Often not. Many excipients are produced in large volumes for non-pharmaceutical industries, with pharmaceutical grade as a segregated portion. IPEC-PQG certification is the excipient specific standard worth asking for.
Yes, though they are assessed differently. Excipient selection starts from what the material must do in the formulation, which is a different question from the one an API specification answers.
Send the product or molecule, the grade, the quantity and the destination market. You will get a considered answer about what can be sourced and what documentation comes with it.