Benztropine Market

The Benztropine market is witnessing a CAGR of 6% during the forecast period of 2025-2035. Benztropine mesylate is a synthetic anticholinergic compound that has structural elements from atropine and diphenhydramine. It is mainly applied in the medical field for the treatment of Parkinson’s disease and the regulation of extrapyramidal symptoms caused by drugs in the central nervous system. The drug comes in different forms, ranging from oral tablets to injectable drugs, to address different patient requirements.

The production of benztropine mesylate follows strict regulatory standards to ensure product quality, efficacy, and safety. The United States Food and Drug Administration (FDA) regulates the approval process for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) for benztropine mesylate. For example, FDA’s ANDA 90-233 approval package includes extensive information on the formulation, labeling, and regulatory compliance of the product.

Pharmaceutical manufacturers engaging in the production of benztropine mesylate are required to adhere to the FDA’s Current Good Manufacturing Practice (CGMP) regulations. The regulations cover all aspects of production, such as the upkeep of facilities, calibration of equipment, training of staff, and validation of the process. Such adherence guarantees that the drug is of uniform quality and is not contaminated.​

The FDA Orange Book, titled formally as “Approved Drug Products with Therapeutic Equivalence Evaluations,” has benztropine mesylate included as a listed approved drug product. Included in the list is the information on the therapeutic equivalence of generics over their branded competitors.