Cipla’s manufacturing facility at Pithampur, Indore receives “Official Action Indicated” classification from U.S. FDA for not meeting regulatory requirements; OAI status may delay/hold product pending approval

BENGALURU, Aug 5 (MeelBijendra) – Late on Saturday night, Indian drugmaker Cipla received an ‘Official Action Indicated’ (OAI) classification from the United States Food and Drug Administration’s (USFDA) inspection carried out in February 2023 at Cipla’s manufacturing facility in Pithampur, Indore.

The United States Food and Drug Administration (USFDA), an agency of the United States Department of Health and Human Services, had conducted a Current Good Manufacturing Practice (cGMP) inspection at Cipla’s Pithampur manufacturing facility from February 6, 2023 to February 17, 2023.

Cipla’s manufacturing facility at Pithampur had received 8 inspection observations in Form 483 on completion of USFDA inspection, following which the company said it will comply with the USFDA’s regulatory mandate and claimed to comprehensively address them within the given time period.

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On 5 August 2023, the United States Food and Drug Administration (USFDA) directed drug maker Cipla to classify the company’s manufacturing facility at Pithampur, Indore as Official Action Indicated (OAI) for not meeting regulatory requirements. USFDA indicated that Cipla’s Pithampur manufacturing facility may be subject to further regulatory action and delay/withholding of pending product approvals due to Official Action Indicated (OAI) status.

Cipla has 3 different products undergoing clinical trials with filings targeted in FY25 in North America and 4-5 peptides are expected to be launched soon and a few more are expected to be filed by the end of December 2024. In response, Cipla said it does not see any major risk in its existing commercial product portfolio and the company is in the process of implementing a risk mitigation plan for its new products.

Cipla is the third largest pharmaceutical manufacturer in India with 34 manufacturing units at 8 locations in the country and 47 manufacturing locations across the world, selling its products in 86 countries. Cipla reported a revenue of INR 6,329 Crore in Q1 FY24 with contribution from 44% India; 29% North America; 12% South Africa, Sub-Saharan Africa, QCIL and Cipla Global Access; 12% Emerging international market and Europe; 2% API; and 1% other.

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