"The company has received abbreviated new drug application (ANDA) approval from the United States Food and Drug Administration (USFDA) for Tobramycin injection USP, 80mg/2mL and 1200mg/30mL multiple dose vials," Claris Lifesciences said in a filing to BSE.
The estimated market size of the product in the US is USD 6 million. The product is currently in shortage list of USFDA, it added.
With this approval, the company has a total of 14 approvals and 24 under approval ANDAs and is expecting more product approvals during the year, Claris Lifesciences said.
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