Betahistine Dihydrochloride Market

The Betahistine Dihydrochloride market is witnessing a CAGR of 4.3% during the forecast period of 2025-2035. Betahistine dihydrochloride is a histamine analogue that is used mainly in the management of vertigo and balance disturbances of Ménière’s disease. Its mechanism of action is thought to be due to its capacity to enhance inner ear microcirculation, thus diminishing the frequency and intensity of vertigo attacks.

Betahistine dihydrochloride is not approved by the Food and Drug Administration (FDA) in the United States for general medical use. Nevertheless, it has been approved as an orphan drug for the management of obesity associated to Prader-Willi syndrome, a rare genetic disorder. This was approved on November 8, 2007, and it recognizes the potential therapeutic value of betahistine dihydrochloride for this condition, even though it has not yet been approved for this purpose.

Although not FDA-approved, betahistine dihydrochloride can be found in the United States in compounding pharmacies. Compounding pharmacies create tailor-made medications for specific patient needs, including drugs made from betahistine dihydrochloride. There have been some concerns about the use of old ingredients in the practice of compounding. For example, an FDA inspection of Vann Healthcare Services Inc. in Glasgow, Kentucky, showed expired ingredients being used in compounding betahistine dihydrochloride capsules, which underscored the essential role of complying with strict quality control procedures in drug compounding. Globally, betahistine dihydrochloride’s presence is stronger. In Europe, for instance, it is sold under multiple brand names and comes in several formulations such as 8 mg, 16 mg, and 24 mg tablets. These medications are approved for treating vestibular vertigo and Ménière’s disease, evidencing wider acceptance and use in some parts of the world.

Industrial production of betahistine dihydrochloride entails usual pharmaceutical manufacturing processes, such as chemical synthesis, purification, and formulation into dosage units. Manufacturers are required to adhere to Good Manufacturing Practices (GMP) for product quality, safety, and efficacy. Country-specific regulation by agencies like the European Medicines Agency (EMA) and health authorities at a national level is responsible for approval and monitoring processes.