In the midst of an ongoing controversy around popular antacid drug Ranitidine, pharma major Strides Pharma Science has resumed sales of batches of Ranitidine tablets in the Australia market as it has received green signal from the country’s regulatory body Therapeutic Goods Administration (TGA) for the same.
The Bengaluru-based company had last month temporarily suspended the manufacturing and sale of its Ranitidine tablets for the US and Australia markets given the concerns around an impurity called N-nitrosodimethylamine (NDMA), associated with an increased risk of cancer.
“Batches manufactured by Strides are now available for sale in Australia through its partner Arrow,” the company said in an exchange filing on Wednesday.
According to the TGA results on Ranitidine samples, out of the 135 batches which were tested by the regulatory body, 109 batches were found to have NDMA level at or above the acceptable limit of 0.3 ppm. “These batches include 3 batches from Strides supplied to its Australian partner Arrow Pharma,” said the company.
Also only 24 oral solid dosage batches were found to have levels of NDMA within the acceptable limit of 0.3 ppm of which 20 batches were manufactured by Strides for Arrow, according to the filing. Strides said it has also submitted all requested data to the US Food and Drug Administration (USFDA) in response to the Information Request received on Ranitidine and is awaiting further feedback on the NDMA limits from it.
Strides predominantly sells Ranitidine tablets in the US markets, and its front end sales globally for the product were $9 million in H1FY20. It has approval for both prescription and over-the-counter Ranitidine tablets for the US market but has only commercialised the prescription product currently. The company holds over 30 per cent share in the US Ranitidine prescription market.
Apart from Strides Pharma, Aurobindo Pharma and Granules India are other Indian drug companies that have permission to sell Ranitidine products in the US. The domestic market for these products is pegged at Rs 700 crore with Cadila Phramaceuticals and GSK (Zinetac) being some of the prominent players. As a precautionary step, Dr Reddy’s Laboratories, Sandoz, Novartis and GSK too have voluntarily recalled their Ranitidine medication sold in global markets.