Nifedipine

As a classic medication of calcium channel blocker class for antihypertension, nifedipine inhibits the transmembrane entry of calcium ions into vascular smooth muscle and myocardial cells, reduces peripheral vascular resistance, and thus achieves the effects of lowering blood pressure and relieving myocardial ischemia. Its clinical application covers patients with essential hypertension of all age groups, and it can also be used for the treatment of chronic stable angina pectoris and variant angina pectoris. Conventional dosage forms are divided into short-acting and long-acting categories. Short-acting preparations are used for rapid blood pressure reduction in hypertensive emergencies, while long-acting controlled-release/sustained-release preparations are used as first-line long-term antihypertensive medications, which greatly improves patients' medication compliance.

The global market size of nifedipine is stably around 4.5 billion US dollars, of which the Chinese market accounts for about 28%, and the compound annual growth rate is maintained at 2.3%. The growth momentum mainly comes from the improvement of diagnosis and treatment penetration rate among primary-level hypertension patients. At present, generic drugs of this variety account for more than 90% of the market share, and the number of domestic enterprises with preparations that have passed the consistency evaluation has reached 37. In multiple rounds of national centralized drug procurement, the average winning bid price of nifedipine sustained-release/controlled-release preparations has decreased by 72% compared with the maximum procurement limit price. The localization rate of upstream active pharmaceutical ingredients (APIs) has exceeded 95%, and enterprises in Hebei and Jiangsu provinces contribute nearly 60% of the domestic production capacity.

The original research enterprise of nifedipine is Bayer Healthcare, and the original brand name is "Adalat GITS". Its core compound patent expired in 1985, and the controlled-release dosage form patent in China expired in 2004. The main marketed dosage forms of the original research are 30mg and 60mg controlled-release tablets, which have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and also listed in the FDA Reference Preparations Catalogue. Up to now, there are a total of 62 nifedipine API registration records on the API registration platform of China National Medical Products Administration Center for Drug Evaluation (CDE), among which 58 are in status "A" (can be used in marketed preparations). The domestically approved nifedipine preparations cover multiple dosage forms such as conventional tablets, sustained-release tablets, controlled-release tablets and soft capsules, with more than 200 approved enterprises. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of nifedipine impurity reference standards, covering all impurity types related to the synthesis process and degradation pathways. All products meet the relevant regulatory requirements of the Chinese Pharmacopoeia and FDA, and most products are in stock. Spot orders placed before 16:00 can be shipped on the same day, which can fully meet the full-process needs of API enterprises for process research and development, quality research and compliance declaration.