 "IPCA Labs stops shipments to US after receiving FDA alert for MP unit")
The Mumbai-based IPCA Labs on Thursday announced that voluntarily suspended shipments to the US from its Madhya Pradesh drug ingredient manufacturing plant after the US Food and Drug Administration (USFDA) expressed concerns regarding the unit. During a recent USFDA inspection at IPCA’s active pharmaceutical ingredients (APls) manufacturing facility situated at Ratlam (Madhya Pradesh), the company had received certain inspection observations in Form 483 from the USFDA.
"Consequent to this, the company has voluntarily decided to temporarily suspend API shipments from this manufacturing facility for the US markets till this issue is addressed," IPCA said in a release. The Form 483 outlined violations including data integrity issues at Ratlam plant.
This voluntarily stoppage of API shipments from the Ratlam manufacturing facility will also have impact on the company's formulations export business to the US market since the company's formulations manufacturing units situated at Piparia (Silvassa) and SEZ, Indore (Pithampur) use the APls manufactured from Ratlam facility for manufacturing formulations for the US market, IPCA said.
Sales of the company is expected to be hit with a loss of Rs 150 crore in next six months, according to company officials. The company expects to address the FDA concerns in about four to six months.
"Consequent to this, the company has voluntarily decided to temporarily suspend API shipments from this manufacturing facility for the US markets till this issue is addressed," IPCA said in a release. The Form 483 outlined violations including data integrity issues at Ratlam plant.
This voluntarily stoppage of API shipments from the Ratlam manufacturing facility will also have impact on the company's formulations export business to the US market since the company's formulations manufacturing units situated at Piparia (Silvassa) and SEZ, Indore (Pithampur) use the APls manufactured from Ratlam facility for manufacturing formulations for the US market, IPCA said.
Sales of the company is expected to be hit with a loss of Rs 150 crore in next six months, according to company officials. The company expects to address the FDA concerns in about four to six months.