J B Chemicals & Pharmaceuticals announced the company manufactures Rantac™ formulations where Ranitidine API is manufactured by third party vendors. The company informed that the company's API vendors have got their product analyzed as per international guidelines to verify the presence of NDMA. They have reported that the NDMA is well within the permissible limits.
In addition, the company has also initiated analysis of the samples of all Rantac formulations for the presence of NDMA. The company has been informed that initial report received indicate NDMA is well within the permissible limit.
As a responsible supplier of Rantac, the company always take and shall continue to take all steps necessary for patient's safety including those directed by the Drugs Controller General (India). The company added that Rantac is being marketed by the Company for over 3 decades and so far no serious adverse events have been reported. The company continues to manufacture and sell the product as per the approved regulatory specifications.