FDA import alert on Ipca plant, stock dips 8%

Last July, FDA had noted data integrity issues at Ratlam unit and Ipca had voluntarily halted shipments to the US from the plant

The US Food and Drug Administration (FDA) has banned imports from Mumbai-based pharma company Ipca Laboratories’ Ratlam plant in Madhya Pradesh, over alleged violations of manufacturing norms.

Following reports on the import alert, the shares of Ipca fell 8.6 per cent from their previous close on BSE to end at Rs 639.15 apiece on Friday.

In its statement, Ipca said: “We wish to inform that the US FDA has issued an import alert on the Ratlam manufacturing facility on January 22. However, four APIs (active pharmaceutical ingredients) manufactured at the facility were excluded from the import alert.” The Four APIs are Hydroxychloroquine Sulfate, Propanolol Hydrochloride, Trimethoprim, Ondansetron. “The company is fully committted to resolving this issue at the earliest,” it added.

In July last year, US FDA had warned the company over data integrity issues at its Ratlam facility, and Ipca had voluntarily halted shipments to the US from this plant. With regard to Ipca’s Form 483 (for inspectional observations) on the Ratlam API facility, the US FDA had listed six serious deviations after inspections done between July 14 and 18 last year.

The voluntarily stoppage of API shipments from the facility will affect the company’s formulation export business to the US market, since Ipca Labs' formulation manufacturing units at Silvassa and SEZ (Indore) use the APls manufactured at the Ratlam plant.

As of 2013-14, the US market accounted for Rs 420 crore (or 12 per cent) of Ipca Labs’ total sales.