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Alkem Laboratories gets US FDA observations on Daman plant

30 Sep 2016 Evaluate

Alkem Laboratories has received thirteen observations from the US Food and Drug Administration (US FDA) after the regulator inspected its manufacturing facility at Daman. US FDA had conducted an inspection at the Company’s manufacturing facility from September 20 to September 29, 2016. The Company shall put together a detailed response with adequate corrective and preventive measures to address the US FDA Observations and the same is proposed to be filed within the timeline stipulated by US FDA.

Alkem Laboratories is a leading Indian pharmaceutical company with global operations, engaged in the development, manufacture and sale of pharmaceutical and nutraceutical products. The company produces branded generics, generic drugs, active pharmaceutical Ingredients (APIs) and nutraceuticals, which it markets in India and International markets.

Alkem Laboratories Share Price

5576.80 -14.05 (-0.25%)
08-May-2026 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1847.30
Dr. Reddys Lab 1293.25
Cipla 1347.70
Zydus Lifesciences 938.90
Lupin 2377.90
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