Despite USFDA ban, JB Chemicals & Pharma continues to market ranitidine in India
Rantac® is being marketed by the Company in India for over 3 decades and so far no serious adverse event has ever been reported
Mumbai: J.B. Chemicals and Pharmaceutical Limited has announced that USFDA has requested for withdrawal of formulations of Ranitidine in the US market over a higher level of NDMA found in some formulations in the market.
Following news over NMDA in September 2019, the Ranitidine API vendors of the Company have ensured that Ranitidine supplied by them meets the international guidelines related to the presence of NDMA and is well within the prescribed limits.
"The Company continues to market Rantac®, formulation of Ranitidine, in India. The Company has taken steps to ensure that the NDMA in the product is within the acceptable limits. The Company continues to evaluate the data obtained from the analysis of the product and the results obtained have been satisfactory", Company added
Further, the Company has not yet launched this product in the US market.
"Rantac® is being marketed by the Company in India for over 3 decades and so far no serious adverse event has ever been reported. As a responsible manufacturer, the Company continues to manufacture Rantac® that complies with all the standards set by the Drugs Controller General of India (DCGI)", Company stated
"The Company shall continue to take all steps necessary for patient's safety and follow further guidance as and when provided by DCGI in this regard", Company further added