The move will also have an impact on Ipca's formulation drug exports to the US
IPCA Labs has voluntarily stopped exporting the active pharmaceutical ingredients (API) manufactured at its Ratlam plant in Madhya Pradesh, to the US. This move came after the USFDA notified the company of certain regulatory issues at the manufacturing plant.
"The IPCA plant had received certain observations in a Form 483 from the US Food and Drug Administration (USFDA), after an inspection", the company said. The company has decided to temporarily suspend API shipments from its Ratlam manufacturing facility to the US market till the issue is sorted out, it added.
Ipca's joint MD Mr AK Jain said, "The company expects to sort out the issue in six months. The stoppage of exports would have an impact of about ₹150 crore."
IPCA has said that its voluntary stoppage of pharmaceutical ingredient exports to the US would impact its export of finished medicine forms (formulations) to the same market. IPCA's formulations manufacturing units in Piparia (Silvassa) and SEZ, Indore (Pithampur) use the ingredients manufactured at the Ratlam plant, the company mentioned further.
