Strides Pharma Science Limited (Strides or Company) today shared further updates regarding the supplies of its Ranitidine Tablets. The Company, on September 27, 2019, temporarily suspended the manufacturing and sale of its Ranitidine tablets for the US and Australia markets given the concerns around impurity called N-nitrosodimethylamine (NDMA) which is associated with an increased risk of cancer. As per European Medicines Agency (EMA), NDMA is present in some foods and in water supplies but is not expected to cause harm when ingested in very low levels3.
Summary of the announcement made by Therapeutic Goods Administration, Australia(TGA)1:
- The TGA Laboratories tested samples of Ranitidine medications available in the Australian market.
- A total of 135 batches from 10 Australian companies were tested for NDMA adapting the newly issued US Food and Drug Administration (USFDA) 2 test method using liquid chromatography with high resolution mass spectrometric detection(LC-HRMS).
- TGA has now taken a decision to recall all Ranitidine products with levels of NDMA at or above 0.3 ppm while all batches with levels below 0.3 ppm are available for sale.
Results from the TGA Laboratories Tests
- Out of the 135 batches of Ranitidine which were tested by TGA, 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 Pty Ltd(Arrow).
- 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 API supplied by Solara Active Pharma Sciences.
Next Steps for Australia
- At Strides, product quality and patient safety is of paramount importance, and we are confident of consistently meeting the acceptable limits of NDMA in Ranitidine.
- Batches manufactured by Strides are now available for sale in Australia through its partner Arrow.
Additional Update on US
- Strides has submitted all requested data to the USFDA in response to the Information Request received on Ranitidine.
- Strides is awaiting further feedback from the USFDA on the NDMA limits for Ranitidine.
Shares of Strides Pharma Science Ltd was last trading in BSE at Rs.342.05 as compared to the previous close of Rs. 350.65. The total number of shares traded during the day was 97027 in over 1664 trades.
The stock hit an intraday high of Rs. 353.75 and intraday low of 336.35. The net turnover during the day was Rs. 33295814.