Fildena Professional, a prescription medication used to treat erectile dysfunction, is regulated by different authorities depending on the country where it is sold. In India, where Fildena Professional is manufactured by Fortune Healthcare, the Central Drugs Standard Control Organization (CDSCO) and the Drugs Controller General of India (DCGI) oversee its approval, production, and quality standards. In the United States and European Union, similar drugs containing sildenafil citrate fall under the regulation of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), respectively. These organizations ensure that the medication meets safety, efficacy, and manufacturing requirements. However, since Fildena Professional is a generic product, its regulation may vary, and it may not have official FDA or EMA approval for sale in Western markets. This is why patients are strongly advised to buy it only from reputable sources and under a doctor’s supervision to ensure safety and authenticity.