Strides Pharma Science has said batches of ranitidine tablets made by the company are now available for sale in Australia through its partner Arrow Pharmaceuticals.
The company had suspended the manufacturing and sale of it’s the tablets for the US and Australia markets in September this year, given the concerns around impurity called N-Nitrosodimethylamine (NDMA) which is associated with an increased risk of cancer, the company said in a filing to the BSE.
The Therapeutic Goods Administration (TGA), Australia, has now taken a decision to recall all ranitidine products with levels of NDMA at or above 0.3 parts per million (ppm), while all batches with levels below 0.3 ppm are available for sale, it added.
Out of the 135 batches of Ranitidine which were tested by TGA, 109 batches were found to have an NDMA level at or above the acceptable limit of 0.3 ppm. These batches include three batches from Strides supplied to its Australian partner Arrow, Strides said.
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 its partner Arrow with active pharmaceutical ingredient (API) supplied by Solara Active Pharma Sciences, it added.
“Batches manufactured by Strides are now available for sale in Australia through its partner Arrow,” said Strides.
The company, however, did not specify the number of batches that are available for sale in Australia.
Strides has submitted all requested data to the United States Food and Drug Administration (USFDA) in response to the information request received on ranitidine. The company is awaiting further feedback from the USFDA on the NDMA limits for the drug, it added.
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