Announcement of the State Drug Administration on the resumption of the import customs clearance filing for loratadine raw materials by Fast Pharma Company

According to the results of overseas drug inspections, the National Medical Products Administration issued the "Announcement of the National Medical Products Administration on Suspending the Import Customs Filing of Loratadine Active Pharmaceutical Ingredients from India's Fasudil Pharmaceutical Company" on March 20, 2019, deciding to suspend the issuance of import customs clearance certificates for the product. After Fasudil Pharmaceutical Company made corrections, they submitted an application to the National Medical Products Administration to resume the import customs filing of Loratadine Active Pharmaceutical Ingredients and related supplementary registration applications. In accordance with the "Drug Administration Law of the People's Republic of China" and the "Regulations on Overseas Inspections of Drugs and Medical Devices", the National Medical Products Administration decided to resume the import of Loratadine Active Pharmaceutical Ingredients produced by Fasudil Pharmaceutical Company after their relevant supplementary application is approved.