The lab results also found that the NDMA impurity in ranitidine drugs sold by Dr Reddy’s and Aurobindo Pharma, Sanofi in beyond permissible limits.
Strides Shasun and Ajanta Pharma’s heartburn and acidity pills Ranitidine sold in the US are found to contain N-Nitrosodimethylamine (NDMA) impurity in permissible levels for 300 mg dosage versions, according to lab results published by USFDA.
The NDMA impurity in Strides’ Nizatidine (chemically similar to ranitidine) is also found to be in permissible limits in 150 mg and 300 mg, respectively.
The lab results are considered positive for Strides and Ajanta.
Strides told stock exchanges that it intends to provide additional updates in the next coming days, including potential recommencement of product distribution by Strides of Ranitidine Rx based on available test results.
Strides Pharma may also gain market share in situations of temporary supply disruption. 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 approvals for both prescription and over-the-counter Ranitidine tablets for the US market but has only commercialised the prescription product currently.
Dr Reddy’s, meanwhile, initiated a voluntary recall of its Ranitidine from the US market. The company had taken an impact of Rs 40 crore on its balance sheet due to recall and loss of business.
NDMA is classified as a probable human carcinogen or cancer-causing based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.
USFDA has set the acceptable daily intake limit for NDMA at 0.096 micrograms or 0.32 ppm for ranitidine.
Although many manufacturers have already recalled ranitidine voluntarily, USFDA said it will recommend recalls to manufacturers with NDMA levels above the acceptable daily intake limit.
The US drug regulator is investigating the presence of the impurity NDMA in ranitidine and nizatidine for both the active pharmaceutical ingredient and finished drugs.
The testing of ranitidine for injection is still ongoing, the USFDA said.Both medicines are H2 blockers which decrease the amount of acid in the stomach.
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