SMS Pharma updates against USFDA statement on Ranitidine
The US Food and Drug Administration (USFDA or the Agency) has to request Ranitidine formulation manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step taken by the FDA in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications. FDA also made a statement as "We didn't observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don't 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".
"As a Ranitidine HCl drug substance manufacturer, we have performed the detailed risk assessment study for the formation of NDMA impurity in the Ranitidine HCl drug substance. It is observed that the NDMA impurity is increasing in the storage of the drug substance. Also, we have identified the root cause of the same", Company stated
"Based on the risk assessment study, we have modified the process of Ranitidine HCl drug substance to control the NDMA impurity during the storage and the modified process details have been submitted to the FDA. The modified process material is more stable and the NDMA impurity is well controlled in our modified process of the Ranitidine HCl drug substance", Company further stated
FDA has also requested all the formulators of Ranitidine HCl to provide the stability data of the drug product at the elevated long term stability conditions to confirm the stability data of the drug product w.r.to NDMA content.
"Some of our customers have initiated the FDA recommended stability studies", SMS Pharma said
"We have already submitted the available stability of Ranitidine HCl drug substance to the USFDA authority recently (March 2020). As per the normal process of GMP guidelines, the USFDA has conducted CGMP inspection in our API manufacturing facility during January 2020 and subsequently, we have received the EIR report. The validation batches of the modified process have been already initiated for the required stability studies and the stability data shall be updated to the Authority as required. We anticipate this activity would take about 9 to 10 months period", Company added
"We further inform you that, to date, we have not sold any Ranitidine API for the commercial distribution in the US. Whatever the quantities sold are for the purpose of drug product development and the product has not entered into commercials till date in the US Market", the company further added
"In view of the above, our commercial supplies of the Ranitidine HCl drug substance to our customers for US market from us is currently delayed by 9-10 months and expected to start by the end the current calendar year. In the meantime we will utilize these capacities to other existing products, hence, no impact on our operations as well as revenues during the current financial year as well as future years", SMS Pharma further said
The share of SMS Pharmaceuticals Ltd's revenue contributed from Ranitidine product during the last couple of year is below 1% of the total revenues.