Oral solid dose manufacturing (tablets and capsules)

Oral solid dose manufacture blends the API with fillers, binders and disintegrants, granulates it (wet or dry), compresses tablets or fills capsules, and coats them, in batches of hundreds of thousands under 21 CFR 211 or EU GMP. For a kinase inhibitor the hard parts are poor solubility (handled with salt forms, amorphous dispersions or particle size control), content uniformity at low doses and the dissolution profile that the regulator ties to the clinical batches. Capecitabine, temozolomide, imatinib and almost every modern kinase inhibitor are made this way.

Generic entry depends on the same chemistry: a generic maker must show bioequivalence to the reference tablet in healthy volunteers and match its dissolution. When imatinib generics reached the United States in 2016 the price fell over the following years to a small fraction of the brand's, the clearest example of how oral generic manufacture changes access. Regulators worry about a different failure mode here than for injectables: nitrosamine and other impurities, and data integrity at plants inspected rarely. The FDA's inspection findings and warning letters to oral solid dose plants are public, and OnCo records them only as a class.