Near-term overhang for Alkem Laboratories' fast growing US business

Any adverse outcome of the FDA's observations will impact the company's overall growth

The Alkem Laboratories stock has shed about 9 per cent over the last few trading sessions after it received 13 observations from the US Food and Drug Administration (FDA) for its Daman formulations plant. The facility contributes about 30 per cent to the company's US revenues and accounts for 25-30 pending abbreviated new drug applications (ANDAs) out of a total pipeline of 60 ANDAs. The US contributes about 21 per cent of the company’s overall revenues. 

Analysts at Nomura say that observations are a concern and highlight that the system is not adequately equipped/staffed to carry out tests in a