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New batch of Ranitidine drug enters Australia
Highlights
Drug firm Strides Pharma Science on Wednesday said batches of Ranitidine tablets made by the company are now available for sale in Australia through its partner Arrow Pharmaceuticals Pty Ltd.
New Delhi: Drug firm Strides Pharma Science on Wednesday said batches of Ranitidine tablets made by the company are now available for sale in Australia through its partner Arrow Pharmaceuticals Pty Ltd.
Strides had suspended the manufacturing and sale of its Ranitidine 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 in
creased risk of cancer, the company said in a filing to the BSE.
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.
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