LONDON: United States Food and Drug Administration (USFDA) is banning products from its manufacturing facility in Ratlam, Madhya Pradesh.
The facility received regulatory observations in July last year, following a USFDA inspection. The preliminary observations on Form 483 resulted in the company voluntarily suspending shipments of active pharmaceutical ingredients (API) from this facility to the US.
But the situation seems to be unresolved, with the company now confirming the import alert to the stock exchange. The company’s stock fell over 8 per cent to Rs. 640 on Friday morning, on the news.
Ipca, however, clarified that four APIs manufactured at the said manufacturing facility were excluded from the import alert. They were Hydroxychloroquine Sulfate, Propanolol Hydrochloride, Trimethoprim and Ondansetron.
Details of the violation by the company that elicited the regulatory action were not given. Last July, company management had indicated that the export-related development would have an impact of about Rs. 150 crore.
