Lupin: Somerset warning implies regulatory environment may no longer offer relief
In its Indian business, Lupin is expected to remain steady due to a better mix and outperformance in chronic therapies
June 14, 2021 / 01:20 PM IST
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Lupin (CMP: Rs 1,197; Market Cap: Rs 54,329 crore) has received a warning letter from the USFDA for its Somerset (New Jersey) facility. This OAI (Official Action Indicated) facility was inspected in the last quarter of CY20 and issued Form 483 with 13 observations. As a follow up to the same, the USFDA has now issued the warning letter.
Apparently the regulatory environment is reverting to the pre-COVID phase for the pharma industry. Due to drug shortages, the regulatory environment, till...