 "IPCA Labs receives USFDA's import alert for MP plant")
IPCA Labs has informed BSE that it has received import alert (an order to ban import) for Ratlam plant (Madhya Pradesh) from US Food & Drug Administration (USFDA).
US FDA had inspected IPCA Labs’ active pharmaceutical ingredients (APls) manufacturing facility at Ratlam in July last year, after which the drug regulator had issued certain inspection observations in Form FDA 483 – notifying the company’s management of objectionable conditions. Consequent to this, IPCA Labs voluntarily decided to temporarily suspend API shipments from this manufacturing facility for the US markets till this issue is addressed.
“We now wish to inform you that US FDA has issued an import alert to the said manufacturing facility on January 22, 2015,” said IPCA Labs in BSE filing.
However, the four APIs - hydroxychloroquine sulfate, propanolol hydrochloride, trimethoprim and ondansetron - manufactured at the Ratlam facility are excluded from the import alert.
“The company is fully committed in resolving this issue at the earliest. The company is also committed to its philosophy of highest quality in manufacturing, operations, systems, integrity and cGMP culture,” added IPCA Labs.
US FDA had inspected IPCA Labs’ active pharmaceutical ingredients (APls) manufacturing facility at Ratlam in July last year, after which the drug regulator had issued certain inspection observations in Form FDA 483 – notifying the company’s management of objectionable conditions. Consequent to this, IPCA Labs voluntarily decided to temporarily suspend API shipments from this manufacturing facility for the US markets till this issue is addressed.
“We now wish to inform you that US FDA has issued an import alert to the said manufacturing facility on January 22, 2015,” said IPCA Labs in BSE filing.
However, the four APIs - hydroxychloroquine sulfate, propanolol hydrochloride, trimethoprim and ondansetron - manufactured at the Ratlam facility are excluded from the import alert.
“The company is fully committed in resolving this issue at the earliest. The company is also committed to its philosophy of highest quality in manufacturing, operations, systems, integrity and cGMP culture,” added IPCA Labs.