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Theophylline, a member of the xanthine class of drugs, plays a crucial role in the management of respiratory conditions, particularly asthma and chronic obstructive pulmonary disease (COPD). This medication acts as a bronchodilator, offering relief to individuals struggling with breathing difficulties. Beyond its primary application in respiratory disorders, Theophylline also exhibits effects on the heart and central nervous system, making it a versatile medication in certain medical scenarios.
The quality, purity, and efficacy of an API are vital to ensuring the safety and effectiveness of the final pharmaceutical product. Regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), impose stringent guidelines and standards for the production and testing of APIs. Manufacturers must comply with Good Manufacturing Practices (GMP), which outline the necessary controls and documentation to guarantee that APIs are consistently produced to quality standards.
drug api definition
