The drug major announced that it has received a warning letter from United States Food & Drug Administration (USFDA) for its injectables manufacturing facility located at Jarod near Vadodara.
The warning letter summarizes violations of current good manufacturing practice (cGMP) regulations but does not include any data integrity related violations.
Earlier on 18 July 2024, the companys Jarod facility had received official action indicated (OAI) status by the USFDA .This site was inspected by USFDA from 15 April to 23 April 2024.
The contents of the warning letter will be made public by the USFDA in due course, said the firm.
The company will take all necessary steps to work with USFDA towards earliest remediation of the above facility, it added
Meanwhile, the company said that it has received a final approval from the USFDA to market Scopolamine Transdermal System.
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Scopolamine Transdermal System is indicated to prevent nausea and vomiting after anaesthesia, narcotic pain medicines, and surgery. It is also used to prevent nausea and vomiting caused by motion sickness. The drug is equivalent to reference listed drug Transderm Scop Transdermal System.
This is the fifth abbreviated new drug application (ANDA) approval for Zydus in the transdermal portfolio, leveraging the groups strengths in the manufacturing of complex drug device dosage forms.
The pharma company said that the drug will be produced at the groups transdermal manufacturing site at SEZ, Matoda, Ahmedabad.
According to IQVIA MAT June 2024, Scopolamine Transdermal System had annual sales of $69.6 million in the United States.
The group now has 400 approvals and has so far filed over 465 ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
The pharma companys consolidated net profit surged 30.64% to Rs 1,419.9 crore in Q1 FY25 as compared to Rs 1,086.9 crore posted in Q1 FY24. Revenue from operations jumped 20.77% year on year (YoY) to Rs 6,207.5 crore in the quarter ended 30 June 2024.
Shares of Zydus Lifesciences shed 0.50% to Rs 1,126.55 on the BSE.
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