29/09/2019
*Good Morning*
*Regards - Amrish Kaushik*
JB Chemicals initiates analysis of samples of Rantac products to verify impurities
In regards to the news reports over presence of impurity called N-nitrosodimethylamine (NDMA) in active pharmaceutical ingredient ranitidine, the Mumbai-based pharma major JB Chemicals and Pharmaceuticals Ltd has initiated analysis of the samples of their Rantac product, and the active pharmaceutical ingredient (API) used for the presence of NDMA.
Based on the news report, Drugs Controller General of India (DCGI) has also directed all State Drug Controllers to look into the matter.
The company said that initial reports look good, however the final report will be available by the middle of next week.
"In addition, the API suppliers are analyzing their product and the manufacturers are verifying their products. As a responsible supplier of Rantac, a brand of ranitidine, we shall take necessary steps for patient's safety," the company said.
The company further added, "Rantac is being marketed by JBCPL for over four decades and so far no adverse events have been reported. We continue to manufacture and sell the product as per approved regulatory specification of USP."
"Neither the US Food and Drug Administration (FDA) nor Drugs Controller General (India) DCGI has initiated a recall on rantidine products at this time. We would like to re-assure the doctors, patients and the entire medical fraternity that the company is committed to quality of its products. We will continue to work in the same manner in the interest of the patients safety," the company added.
The US FDA had last week issued a warning that some ranitidine medicines may contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) at certain levels on extended use. NDMA is known environmental contaminant and found in water and foods, including meals, dairy products and vegetables.
As per US FDA statement, although NDMA may cause harm in large amounts and over long use, the levels FDA has found in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.
