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According to the result of overseas drug inspection, the National Medical Products Administration issued the "Announcement of the National Medical Products Administration on Suspending the Import Clearance Record of Loratadine Active Pharmaceutical Ingredient by Vasudha Pharm Chem Limited from India" (No. 22 of 2019) on March 20, 2019, deciding to suspend the issuance of import clearance certificate for the product. After Vasudha Pharm Chem Limited has made improvements, they have submitted an application to the National Medical Products Administration for the resumption of the import clearance record of Loratadine active pharmaceutical ingredient and relevant supplementary registration applications. In accordance with the Drug Administration Law of the People's Republic of China and the Regulations for Overseas Inspection Management of Drugs and Medical Devices, the National Medical Products Administration has decided to resume the import of Loratadine active pharmaceutical ingredient (English name: Loratadine) produced by Vasudha Pharm Chem Limited after the relevant supplementary application has been approved.
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