Strides ceases distribution of ranitidine tablets in America as USFDA asks makers to withdraw
On Wednesday, the US Food and Drug Administration (USFDA) published a statement and issued letters to all manufacturers of ranitidine across dosage forms requesting withdrawal of all prescription and over-the-counter ranitidine drugs from the market immediately, Strides said in a filing to the BSE.
The latest step by the regulator is based on their ongoing investigation of the N-Nitrosodimethylamine (NDMA) impurity in ranitidine medications, it added.
In a statement, USFDA said it is requesting manufacturers to withdraw all prescription and over-the-counter ranitidine drugs from the market immediately.
The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity, USFDA said.
"We didn't observe unacceptable levels of NDMA in many of the samples that we tested. However, since we do not know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured," it added.
NDMA is a probable human carcinogen, a substance that could cause cancer.
Strides said it will work with the agency regarding the request to withdraw the product from the market immediately.
"Strides also intends to work on generating the required additional data which is requested by the agency to consider allowing ranitidine product back on the US market," it added.
Ranitidine is one of the top-5 products for Strides in the US market, and at this point of time, the company is estimating the full impact on the revenues due to the USFDA requested withdrawal of ranitidine, Strides said.
Strides has approval for Rx and OTC ranitidine tablets for the US market, and it currently commercialises only the Rx product in the US, it added.
"Despite the discontinuation of ranitidine, Strides remains confident of its US business and continues to maintain a positive growth outlook for FY21," Strides said.
Earlier, in November 2019, the USFDA had announced the laboratory testing and analysis of ranitidine and advised the acceptable NDMA limits.
In the summary of test results provided by USFDA, Strides' ranitidine tablets were found to be within the acceptable limits for NDMA.
Subsequently, the company had announced the re-launch of ranitidine tablets in the US market.
It had voluntarily suspended the sales of its ranitidine Rx tablets in September 2019 until the test results were available of its data regarding levels of NDMA in its ranitidine tablets it had submitted to the USFDA.
Another drug firm JB Chemicals & Pharmaceuticals in a regulatory filing said its ranitidine API vendors have ensured that ranitidine supplied by them meets the international guidelines related to the presence of NDMA and is well within the prescribed limits.
Moreover, the company has not yet launched this product in the US market, it added.
"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," JB Chemicals and Pharmaceuticals said.
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), it added.
Rantac is being marketed by the company in India for over 3 decades and so far no serious adverse event has ever been reported, JB Chemicals and Pharmaceuticals said. AKT HRS