Shares of Cipla declined more than 2% in early trade after the company disclosed that the United States Food and Drug Administration (USFDA) has classified a manufacturing facility inspection in Greece as Official Action Indicated (OAI).
The development relates to a current Good Manufacturing Practices (cGMP) inspection conducted at the Rodopi, Greece facility of Pharmathen International S.A.. The facility serves as a supply partner for Lanreotide Injection to Cipla USA Inc., a wholly owned subsidiary of Cipla.
According to the company’s regulatory filing, the USFDA has now classified the inspection status as OAI. This classification indicates that the agency has identified objectionable conditions during the inspection and that regulatory action may be recommended.
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