Solara Active Pharma Sciences announced that the USFDA on 01 November 20191 posted the results of laboratory tests conducted to investigate the presence of the NNitrosodimethylamine (NDMA) impurity levels in all Ranitidine and Nizatidine samples it
tested. USFDA has set the acceptable daily intake limit for NDMA at 0.096 micrograms or 0.32 ppm for Ranitidine which it considers reasonably safe for human ingestion based on lifetime exposure. Basis the
outcomes, USFDA will recommend manufacturers to recall all the products with NDMA levels above these acceptable daily intake limit.
Amongst the samples tested for Ranitidine and Nizatidine, the Company is pleased to note that majority of the marketed products in the US that were found within the acceptable limits were manufactured with the APIs supplied by Solara. The company is a key supplier of Ranitidine Hydrochloride 8L Nizatidine API and partners with global pharmaceutical companies for their formulations.
The Company is engaging with its formulation partners to understand the next steps and will provide an update in the next few days.
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