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Production site in Kemalpaşa, Turkey gains health authority approval to produce GMP-compliant pharmaceutical ingredients aligned with ICH Q7.
April 19, 2023
By: Anthony Vecchione
The Omya facility in Kemalpaşa/Izmir has received Turkish Health Authority accreditation to manufacture calcium carbonate as an active pharmaceutical ingredient (API) in line with the strictest quality requirements and industry-leading GMP-compliant manufacturing practices set out in ICH Q7. Along with its manufacturing sites in the U.S. and France, this is now the company’s third fully certified plant supplying the pharma, nutraceutical, and food industries. The plant is also compliant with the international ISO standards of “Basic Quality” (ISO 9001:2015), ‘’Environment” (ISO 14001:2011) and “Work Safety”. (ISO 45001:2018). Stefan Lander, vice president consumer goods, group sales and marketing at Omya, said, “Having our third plant now certified for the production of pharmaceutical actives and expanding our offerings from Kemalpasa will help us serve our global customers with natural and highly functional minerals, while maintaining a focus on economic and ecological efficiency, which is fully aligned with Omya’s purpose of making life better through our passion for minerals and chemistry.” The company’s mineral particles are processed in Turkey from high-purity marble stone in accordance with the most stringent sustainability and quality standards, and with a very low environmental footprint. In the plant, ultrapure and white calcium carbonate is processed to various morphologies, thus offering a broad range of products with multiple functionalities. The resulting mineral ingredients designated for the pharmaceutical industry under the brand name Omyapure offer numerous benefits for finished products, facilitate production processes and increase nutritional profiles. As a result, Omyapure can be used in antacid products as well as osteoporosis treatments.
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