Tablets & Capsules

TC0920

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Tablets & Capsules September 2020 39 regulations, low labor costs, and lax environmental laws come with ethical concerns. Because the FDA doesn't inspect overseas facilities as regularly as it inspects domestic ones, quality may be a concern. In 2018, the FDA inspected only 20 percent of registered drug manufacturing facilities abroad [5]. These inspections have found that many Asian manufacturing facilities systematically manipulate data, provide false information, and limit facility access to their US partners, leading to concerns about quality control and health risks for American consumers [6]. Because these issues occa- sionally require companies to repeat manufacturing runs, the cost savings of overseas manufacturing may not be as significant as they once were. Concerns about quality have only increased with COVID-19. The FDA has halted in-person overseas inspections during the outbreak [7]. North American buyers have less information than ever about the status or reliability of overseas products. Increased use of gelatin The reduced pharmaceutical supply of gelatin isn't necessarily a recent or temporary phenomenon. The population in many industrialized countries is rap- idly aging, as life expectancy increases and birth rates decline. Older adults are more likely to have chronic conditions and require a variety of prescription medi- cations, meaning that the pharmaceutical industry will Gelatin and other shortages during COVID-19 Raw gelatin is often sourced from countries across North or South America, Europe, or Asia. The biggest raw gelatin importer is the US, which brought in $258 million worth of gelatin in 2018, with about 20 percent coming from Asia and 25 percent from Europe (Figure 1) [1]. During the pandemic, many countries have shut down meat-processing facilities and euthanized animals, limit- ing the availability of gelatin. Indian capsule manufactur- ers have cut production by 30 to 40 percent due to a lack of raw gelatin, and capsule prices have risen because gela- tin demand has driven costs up [2]. Other pandemic-related problems have also arisen throughout the pharmaceutical supply chain. Many Asian manufacturing facilities shuttered operations in the wake of COVID-19. Indian pharmaceutical companies, which receive 70 percent of ingredients from Chinese manu- facturers, responded by limiting the export of dozens of pharmaceuticals [3]. Additionally, many nations have closed their borders and restricted flights in recent months, leading to ship- ping delays. These factors have led to concerns about medicine availability throughout North America. Ethical concerns about Asian manufacturing facilities Through the 1960s, US drug products were largely manufactured domestically. Over the following decade, pharmaceutical manufacturing began shifting away from the North American continent, and now largely takes place in various Asian countries [4]. The primary reason for the shift was lower prices, but Asia's less stringent Figure 1 2018 US gelatin imports by country of origin Brazil 27.3 Canada 12.3 Argentina 11.8 Germany 7.92 China 7.51 Belgium-Luxembourg 6.51 South Korea 4.72 UK 3.8 Japan 3.31 India 3.23 Other 11.6 Allendale, New Jersey Óä£ÈÓnÓääÊUÊÜÜÜ°À>iiÀÕðV `Ài°*iÌÀVJÀ>iiÀÕðV For 35 YEARS the pharmaceutical industry has relied upon ÀBiÀ to de-dust, de-burr and convey tablets with the highest efficiency. To learn more about how to *,"6 the EFFICIENCY of your tableting lines contact Kraemer U.S. Tablet de-dusting solutions from the Global Leader In 2018, the FDA inspected only 20 percent of registered drug manufacturing facilities abroad.

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