China’s National Medical Products Administration (NMPA) announced on August 20, 2025, that it had resumed the import of loratadine API produced by India-based Vasudha Pharm Chem Limited. This decision followed the company’s completion of required rectifications and the subsequent approval of its supplemental applications.
Background on Suspension
The NMPA had suspended the issuance of import clearance certificates for Vasudha’s loratadine API on March 20, 2019, based on the results of an overseas drug inspection.
Resumption Process
After completing rectifications, Vasudha reapplied for import clearance registration. Following a technical evaluation confirming the adequacy of the company’s corrective actions, the NMPA decided to resume imports of Vasudha’s loratadine API.-Fineline Info & Tech
