USFDA issues import alert on Ipca Lab Ratlam facility

The US health regulator has issued import alert on drugs produced at Ipca Laboratories Ratlam 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 US Food and Drug Administration (USFDA) has issued an import alert to the said manufacturing facility (Ratlam ) on January 22, 2015," 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 US markets till this issue is addressed, it added.

Under the import alert, authorities can detain without physical examination of unapproved new drugs promoted in the US.
The development follows an inspection by at the company's API manufacturing unit at Ratlam in Madhya Pradesh by US Food and Drug Administration (USFDA) officials, who had made certain inspection observations in Form 483, it added.
Under Form 483 Form USFDA officials communicate concerns related to non-compliance of manufacturing norms discovered during inspections at manufacturing units but is not a final observation from the US health regulator.
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 of Ipca Laboratories were trading at Rs 643 per scrip during the afternoon trade, down 8.05 per cent from the previous close on the BSE.