Lupin Ltd. was the top loser on the NSE Nifty 50 Index after the U.S. regulator highlighted six shortcomings in the drugmaker's Indore plant.
Shares of Lupin fell as much as 6.5 percent to Rs 1,189, before recovering to trade 4.2 percent lower as of 2:00 p.m. Other pharmaceutical majors, including Cipla Ltd., Sun Pharmaceutical Industries Ltd. and Dr. Reddy's Laboratories Ltd. also fell between 1 percent to 2 percent, after Bloomberg News reported that the Donald Trump administration is close to issuing an executive order aimed at lowering U.S. drug costs.
Indore Plant: FDA's Observations
- #1: Failure to review unexplained discrepancy on whether or not the batch of medicines has already been distributed.
- #2: Written records of investigations into unexplained discrepancies do not include conclusions and follow-ups.
- #3: No written procedures for production and process controls designed to assure drug purity, identity, and strength.
- #4: Batch production and control records are deficient.
- #5: Inappropriate equipment design.
- #6: Written procedures not established for cleaning and maintenance of equipment.
During an earnings call with analysts on May 24, Nilesh Gupta, the group president and managing director of Lupin had said that none of the observations were related to data integrity and that the company would be able to address these issues.
I do not see the situation escalating and I feel that we will be able to address it pretty comprehensively.Nilesh Gupta, MD, Lupin (May 24)
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