Shares of Cipla Ltd slumped 5% on 7 January after the US Food and Drug Administration (USFDA) disclosed details of its findings on Pharmathen International.
Cipla has a contract manufacturing agreement with Pharmathen, based in Greece, to commercialise tumour medication Lanreotide in the United States, and the regulatory action has had an impact on investor sentiment.
The observations, according to the USFDA, point to a number of compliance shortcomings at Pharmathen sites.
These include insufficient methods for preventing contamination and ineffective control systems for maintaining sterile environments. The regulator also identified flaws in aseptic processing facilities and laboratory controls, such as the lack of adequate procedures.
The FDA also stated difficulties in developing suitable systems to maintain the purity and quality of drug goods, as well as breaches in adhering to approved sampling plans and testing methods.
In addition, the buildings used for manufacturing were discovered to be in terrible condition.
At 12:59 pm, the shares of Cipla were trading 4.02% higher at Rs 1,469.20 on NSE.
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