Amid an ongoing controversy around popular drug Ranitidine, pharma major Strides Pharma Science could soon resume sale of the antacid in the US market as the country’s drug regulator has found them safe for use. The company holds 33 per cent share in the US Ranitidine prescription market.
According to the US Food and Drug Administration (USFDA), Strides’ Ranitidine tablets 300 mg is within the acceptable limits for N-nitrosodimethylamine (NDMA) of 96 nanograms per day or 0.32 ppm.
“We will soon provide updates on potential recommencement of product distribution in US markets of Ranitidine based on available test results,” said the company.
The Bengaluru-based company had last month temporarily suspended the manufacturing and sale of the antacid in the US and Australia markets given the concerns around the NDMA impurity, which is associated with an increased risk of cancer. It has since then resumed sales in Australia.
“We expect Strides Pharma (NDMA level below permissible limits) and JB Chemicals to benefit the most among companies in our coverage universe. Strides Pharma may also gain market share in situations of temporary supply disruption,” said an ICICI Securities analyst.
Apart from Strides, other manufacturers whose products’ NDMA concentration was within acceptable limits were Mumbai-headquartered Ajanta Pharma and Sanofi.
However, samples of Dr Reddy’s, Sandoz, Aurobindo, Silarx and Amneal were found to have higher levels of NDMA. The USFDA though is still to test the drugs in human body, noted ICICI Securtities analysts. The regulator has recommended these companies, whose products showed higher NDMA levels than the permissible limits, to voluntarily recall the drug. The USFDA also announced that NDMA levels found in ranitidine are similar to the levels in common food items such as grilled or smoked meats.
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.