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国家医保局取消Dr. Reddy's Laboratories Ltd.盐酸托莫西汀胶囊中选资格并将该企业列入违规名单

The National Medical Insurance Bureau canceled the selection qualification of Dr. Reddy's Laboratories Ltd.'s Temozolomide Hydrochloride Capsules and included the company in the list of violations.

Breakings ·  Aug 30 21:10

During the inspection by the National Medical Products Administration, Dr. Reddy's Laboratories Ltd.'s Temozolomide Hydrochloride Capsules exhibited serious deficiencies in the management of active pharmaceutical ingredients, failing to take effective measures to ensure the validity period of the active pharmaceutical ingredients used complies with China's registration requirements. Additionally, there were deficiencies in process validation, quality control, and other areas that do not meet the requirements of China's "Drug Production Quality Management Standards (Revised in 2010)." On August 30, 2024, the National Medical Products Administration issued an announcement to suspend the import, sale, and use of the product. The Joint Procurement Office decided to cancel the selection qualification of Dr. Reddy's Laboratories Ltd.'s Temozolomide Hydrochloride Capsules and include the company in the "violation list," suspending the company's eligibility to apply for participation in the national centralized drug procurement activities from August 30, 2024, to February 28, 2026.

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