Shares of JB Chemicals, Solara Active and Strides Pharma Science were down 6-10 percent intraday on April 3 after the US health regulator requested all manufacturers to withdraw all prescription (Rx) and over-the-counter (OTC) Ranitidine drugs from the US market immediately.
This latest step is based on their ongoing investigation of the N-Nitrosodimethylamine (NDMA) impurity in Ranitidine medications.
As per a statement from the US Food and Drug Administration, the agency has determined that the NDMA impurity in some Ranitidine formulation products increases over time and when stored at higher than room temperatures it may result in consumer exposure to unacceptable levels of NDMA impurity.
“As a result of this immediate market withdrawal request for all Ranitidine products, Solara has stopped further manufacturing and distribution of
Ranitidine API for the US market,” said Solara Active in its BSE filing.
The company further said it would engage with its formulation partners to understand the next steps and additional data that it needs to generate for supporting their product’s relaunch to the market in an extended period.
Ranitidine is an Rx and OTC drug used as an H2 (histamine-2) receptor blocker, which decreases the amount of acid created by the stomach.
Strides said it has approval for Rx and OTC Ranitidine tablets for the US market, and it currently commercializes only the Rx product in the US.
In September 2019, following a citizen petition filed in the US by an online pharmacy, the USFDA had learned that some ranitidine medications contain NDMA at low levels and FDA issued a statement alerting patients of NDMA found in samples of Ranitidine. The agency, then, did not announce any intention to recall the product and requested all Ranitidine manufacturers to conduct laboratory testing to examine levels of NDMA in Ranitidine, recommending the use of an LC-HRMS testing protocol.
Consequently, Strides submitted the requested data to the USFDA and until test results were available, Strides voluntarily suspended the sales of ranitidine Rx tablets in September 2019, the company said.
In November 2019, USFDA announced the Laboratory testing and analysis2 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 of 96 nanograms(ng) per day or 0.32 parts per million (ppm) which was also considered reasonably safe by most of the regulators for human ingestion based on lifetime exposure.
Subsequently, Strides said it announced the relaunch of Ranitidine tablets in the US market. The company also tested the NDMA content for all its commercial batches and its product met and continued to meet the FDA recommended NDMA specification limit of NMT 0.32 ppm within the labelled expiration date.
Meanwhile, JB Chemicals said it continued to market Rantac, the formulation of Ranitidine, in India. The company has taken steps to ensure that the NDMA in the product is within the acceptable limits.
Further, the company said it has not yet launched this product in the US market.
Solara Active said Ranitidine API was amongst its top 10 APIs for company and contributed around 7 percent to its total revenues. “Solara does not foresee any significant impact on its growth trajectory and continues to maintain a positive outlook for the future.”
JB Chemicals was trading at Rs 455, down 9.86 percent, Solara was down 4.37 percent at Rs 434.70 and Strides Pharma was down 5.09 percent at Rs 309.70 on the BSE at 1458 hours IST.