Times of India | 4 days ago | 25-11-2022 | 04:03 am
Panaji: Two major pharmaceutical firms have received adverse remarks from the US Food and Drug Administration (USFDA) regarding manufacturing practices at their Goa-based facilities. The USFDA has issued a warning letter to Glenmark while also recommending regulatory administrative sanctions for Cipla’s manufacturing facility.Both the firms said that while they are taking steps to correct the concerns flagged by the US drug regulator, operations at their respective plants will not be disrupted.The USFDA had conducted an inspection of Glenmark’s manufacturing facility in May after which it had issueda note on August 27 informing the firm that the manufacturing facility has been marked for Official Action Indicated (OAI).“We wish to inform that the USFDA has now issued a warning letter to the Goa (India) facility,” said company secretary and compliance officer at Glenmark, Harish Kuber. “The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility.”According to the USFDA definition, OAI means “objectionable conditions were found and regulatory administrative sanctions by FDA are indicated” during inspections.Kuber said that Glenmark is committed to work along with the USFDA to “implement all the necessary corrective actions required”, to address the concerns at the earliest. “The company is committed to maintaining the highest quality and compliant manufacturing standards at all of its facilities across the globe,” said Kuber.Similarly, the USFDA had conducted an inspection of Cipla’s Goa manufacturing facility in August, based on which it has now classified the plant as OAI, which may delay approvals for medicines and medical supplies.“We wish to inform that the company has received a communication from the USFDA that the classification of the company’s said facility continues to be as OAI. The USFDA may continue to withhold product approvals from this facility till the outstanding observations are resolved. The company has an ongoing de-risking plan in place for new product approvals. It will work closely with the USFDA and is committed to address these within the stipulated time,” said Cipla’s company secretary, Rajendra Chopra.The two firms have voluntarily made the disclosures to the stock indices as per the regulations.
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