Claris Lifesciences has received the United States Food and Drug Administration (USFDA) approval for its Abbreviated New Drug Application (ANDA) for Tobramycin Injection USP, 80mg/2mL and 1,200mg/30mL multiple dose vials.
Tobramycin Injection is an anti-infective used to treat certain serious infections that are caused by bacteria such as meningitis and other infections of the blood, abdomen (stomach area), lungs, skin, bones, joints, and urinary tract. The estimated market size in the US is $6 million, as the product is currently in shortage list of the US drug regulator.
With this approval, Claris now has 14 approvals and 24 under approval ANDAs. The company expects more product approvals during the year, which will allow it to continue its growth in the US market.
| Company Name | CMP |
|---|---|
| Redington | 227.35 |
| Adani Enterprises | 2225.25 |
| Amrapali Industries | 17.27 |
| Rashi Peripheral | 474.40 |
| PDS | 291.45 |
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