However, stringent regulatory guidelines of FDA in the manufacturing of finished drugs will limit growth of ranitidine market. For instance, in March 2018, the Ministry of Food and Drug Safety, South Korea banned the imports of 150 mg Zantac (ranitidine) supplied by GlaxoSmithKline (GSK) Korea, for 4 months (March to June 2018) due to its different shape and coatings. According to the same source, South Korea’s Ministry of Food and Drug Safety report, GSK violated Pharmaceutical Affairs Act by changing the approved shape of Zantac. Zantac is supposed to be white and round with thin film-coatings on both side, while GSK distributed Zantac with thick coated film and also coating around some of the tablets were slightly broken. Changes in color, taste, and packaging might hurt the safety and efficacy of drugs, which directly affects the quality of product.
Furthermore, one of the major challenges in determining prevalence of GERD is to identify the patients’ suffering with the condition. Patients suffering with GERD-related symptoms do not consult healthcare professionals until the symptom gets severe. . Direct costs associated with GERD disease include costs of over-the-counter and prescription medications, physician office and hospital visits, surgical costs, and costs of treating other possible complications such as Barrett's esophagus and esophageal adenocarcinoma, which may result from the disease. This is expected to limit the growth of ranitidine market, over the forecasted period.
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