FDA import alert on IPCA plant, stock dips over 5%

Ipca had voluntarily halted shipments to the US from the plant last year

The US Food and Drug Administration (FDA) has banned imports from Mumbai-based generic drugmaker Ipca Laboratories Ltd's Ratlam plant in Madhya Pradesh due to violations of manufacturing norms.

Ipca shares went down by 5.6% at Rs 659.9 intra-day on Friday.

In July last year, FDA had informed about data integrity issues at the Ratlam plant and Ipca had voluntarily halted shipments to the United States from the plant.

With regards to the IPCA's Form 483 on the Ratlam API facility in Madhya Pradesh, the US FDA had listed six serious deviations during inspection done between July 14-18 of 2014.

The voluntarily stoppage of API shipments from the Ratlam manufacturing facility will also have an impact on the company's formulations export business to the US market. The company's formulations manufacturing units situated at Piparia (Silvassa) and SEZ, Indore (Pithampur) use the APls manufactured from the Ratlam facility. 

As of FY2014, the US market contributed sales of Rs 420 crore (12% of total sales) for IPCA Labs.