The U.S. health regulator has issued import alert on drugs produced at the Ratlam facility of Ipca Laboratories in Madhya Pradesh, following which the company has suspended shipment of active pharmaceutical ingredients to the American market.
“We now wish to inform you that the U.S. Food and Drug Administration (USFDA) has issued an import alert to the said manufacturing facility (Ratlam ) on January 22,” Ipca Laboratories said in a filing to the BSE.
Consequently, the company has voluntarily decided to temporarily suspend API (active pharmaceutical ingredients) shipments from this manufacturing facility for the U.S. markets till this issue is addressed, it added.
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Under the import alert, authorities can detain without physical examination of unapproved new drugs promoted in the U.S.
The development follows an inspection at the company’s API manufacturing unit at Ratlam by the USFDA officials, who had made certain inspection observations in Form 483, it added.
Under Form 483, USFDA officials communicate the concerns related to non-compliance of manufacturing norms discovered during inspections at manufacturing units. But it is not a final observation from the U.S. health regulator.
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However, four API’s — Hydroxychloroquine Sulfate, Propanolol Hydrochloride, Trimethoprim and Ondansetron — manufactured at the said manufacturing facility are excluded from the import alert, it added.
Shares tank over 8 % Shares of Ipca Laboratories ended with a steep loss of over 8 per cent on Friday. After plunging 8.9 per cent to Rs.637 intra-day trade on the BSE, shares of Ipca Lab finally ended at Rs.639.15, down 8.60 per cent from the previous close.
At the NSE, the stock slumped by 8.74 per cent to close at Rs.637.85.
The company’s market value tumbled Rs.760.84 crore to Rs.8,064.16 crore.