National Medical Products Administration: Suspend the import, sale, and use of Cadila Pharmaceuticals Limited's amlodipine besylate raw material.

People’s Finance News, April 3: The National Medical Products Administration (NMPA) issued an announcement. Recently, the NMPA organized on-site inspections of the active pharmaceutical ingredient (API) amlodipine besylate API from Cadila Pharmaceuticals Limited.

Upon investigation, it was found that, in the above product, some of the actual production process addresses do not match the registration information. In addition, during production there were multiple changes that were not reported in a timely manner as required, and the actual manufacturing process does not match the approved process, among other issues. This does not comply with the requirements of China’s “Good Manufacturing Practice for Pharmaceutical Products (2010 Revised)” and the relevant provisions in the appendices.

Pursuant to relevant regulations, the NMPA decided, effective immediately:

1. Suspend the importation of the above API, and the drug supervision and administration departments at all ports shall suspend the issuance of import clearance documents for this API product.

2. In the NMPA’s Center for Drug Evaluation (CDE) “Registered Information for Drug Substance and Excipients,” under “Results of joint review and approval with the drug product,” the above API shall be adjusted to “I” (i.e., not passed the joint review and approval with the drug product).

3. The above API may not be sold within China and may not be used for the production of pharmaceutical drug products. For drug products that have already used the above API in manufacturing, they may not be released. For drug products that have already been approved and released to the market, the holder of the drug marketing authorization shall immediately conduct investigations and assessments, and take necessary risk control measures based on the results of the assessment.