Shares of Lupin Ltd were trading in the red and 1.5% lower on 17 September after the company’s Nagpur injectable facility received six observations from the US regulator. 

Lupin stated that the US Food and Drug Administration (USFDA) performed an examination of the facility from 8 September to 16 September. The corporation, however, has not detailed the nature of the observations.

In its regulatory filing, the company said, “We will address the observations and respond to the USFDA within the stipulated timeframe. We are committed to be compliant with current good manufacturing practices (CGMP) quality standards across all our facilities.” 

Earlier this month, the US FDA approved Lupin’s abbreviated new drug application (ANDA) for Risperidone Injectable, which is used to treat schizophrenia and bipolar disorder.

The injectable is bioequivalent to the reference medicine, Risperdal Consta Long-Acting Injection.

Lupin said that the US FDA has approved Risperidone for extended-release injectable solution in single-dose vials of 25 mg, 37.5 mg, and 50 mg.

At 11:56 am, the shares of Lupin were trading 0.70% lower at Rs 2,037.50 on NSE.

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