Lupin US Launches On Track But Albuterol 'Clarity' Awaited

Defers FDA Reinspection Timelines

 
• By Vibha Ravi
  
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After lower growth in India business and impaired operations at five manufacturing units hit by US FDA action impacted Lupin's third-quarter revenues, one-offs sent its net profit crashing. While deferring reinspection timelines for its Goa and Somerset plants, the company remains confident of adding at least 15 products to its US portfolio in FY21.

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Lupin Counting On New Products To Change US Growth Trajectory • Source: Shutterstock

Lupin Ltd. is on track with timelines for new product launches and expects US Food and Drug Administration (FDA) approval for its generic version of Teva Pharmaceutical Industries Ltd.'s ProAir (albuterol sulfate metered dose inhaler) in the first half of fiscal 2021. The key asset is expected to help propel the Indian firm’s growth in the inhalation segment in the US, but approval timelines have been somewhat unclear thus far.

Lupin's plans for a launch in FY20 were derailed by a complete response letter (CRL). “We responded to the CRL...

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