Stock Market Today: Cipla share price gained 10% in the morning trade on Thursday, October 31 after the company announced that its Goa facility has been classified as Voluntary Action Indicated (VAI). With the successful completion of the inspection, Cipla can now launch large products from the facility in the US.
Cipla share price opened at ₹1,518.55 on the BSE on Friday, more than 7 % higher than the previous close of ₹1417.45. Cipla share price thereafter rose further to scale the day's high of ₹1,557.45, marking gains of almost 10%.
The company in its release on the exchanges post market hours on Wednesday said that the United States Food and Drug Administration (USFDA) vide communication dated Wednesday, 30th October 2024 (8:28 p.m. IST) has classified the above-referred inspection as Voluntary Action Indicated (VAI).
The Voluntary Action Indicated means that the agency has neither taken nor recommended any administrative or regulatory action post the inspection completion. The same means that the Goa plant is compliant with the Good Manufacturing Practices (cGMP) framework laid down by the USFDA and hence the company can get FDA approval to launch products from this facility.
The routine current Good Manufacturing Practices (cGMP) inspection at the company’s manufacturing facility in Goa was held between June 10-21.
Among the anticipated large product launches from the Goa facility is the generic version of the oncology drug Ambraxane, which is used in chemotherapy treatments.
The launch of generics has been delayed for some time, as Cipla submitted filings for Ambraxane generics from its Goa facility. However, the facility remained under scrutiny by the US FDA, leading to prolonged approval delays.
Analysts at Elara Securities India Pvt Ltd in their recent report had said that “Abraxane generic launch is now closely tied with the clearance of the Goa facility by the USFDA, as the alternative contract manufacturing option is turning out to be more time consuming than originally thought”.
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