Nadolol

As a representative variety of the second-generation non-selective β-blockers, nadolol exerts multiple effects of slowing heart rate, reducing myocardial oxygen consumption, and inhibiting renin release on the premise of no intrinsic sympathomimetic activity, through competitively blocking β₁ and β₂ adrenergic receptors. It is clinically mainly used for the long-term treatment of hypertension and angina pectoris, and can also be used to control the symptoms of tachycardia in patients with hyperthyroidism, especially suitable for adult patients who require long-term stable heart rate control and have poor tolerance to short-acting β-blockers. Its long half-life of 17 to 24 hours supports once-daily administration, which can significantly improve patients' medication compliance.

The global market size of nadolol preparations is approximately USD 230 million, and the compound annual growth rate from 2023 to 2028 is expected to remain at around 2.1%. The growth drivers mainly come from the improvement of the coverage of primary-level hypertension diagnosis and treatment and the expansion of the elderly cardiovascular disease patient population. At present, the global market is dominated by generic drug supply, and the generic drug substitution rate in the United States has exceeded 92%; the Chinese market is still in the introduction stage, the proportion of nadolol use at public medical institution terminals accounts for less than 0.5% of the overall β-blocker market, and no enterprise has passed the consistency evaluation yet, so there is a clear market space for subsequent generic drug development. (Unless otherwise specified, relevant data are derived from publicly available industry statistical materials.)

The original research enterprise of nadolol is Bristol-Myers Squibb, with the original brand name Corgard, and its core compound patent in the United States expired in 1993. The main dosage form approved for the original drug is tablet, with specifications including 20mg, 40mg, 80mg, 120mg and 160mg. The original tablet has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in China's *Catalog of Reference Preparations for Chemical Drugs*. As of the retrieval time point, there is no valid nadolol registration number in Status A on China CDE API registration platform. Only a few domestic enterprises have obtained the production approval for nadolol tablets, and no imported original research preparation has been marketed. (Data are as of June 2025, please refer to the official website of CDE for the latest information.)

CATO can provide a full set of impurity reference standards for nadolol API, most of which are available from stock. Spot orders submitted before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide reliable reference standard support for API and preparation enterprises in links such as quality research, stability study, registration and declaration.