Daiichi says new API import ban will affect Ranbaxy's US ops
The Toansa, India, active pharmaceutical ingredients (API) facility was subjected to a US Food and Drug Administration (FDA) inspection earlier this month resulting in a Form 483 listed a number of deviations from good manufacturing practice (GMP) standards.
Today the firm confirmed the plant has joined a list of its other troubled sites – Paonta Sahib, Dewas and Mohali, all in India – which fall under a 2012 consent decree, banning the manufacture and import of product from the plant for use in the US.
The ban includes the supply of Ranbaxy’s own APIs to its Ohm Laboratories manufacturing site in New Jersey which produces solid dosage forms of analgesics, antibiotics, anti-diarrhoeal, laxatives, antacids and cough & cold remedies.
“Theoretically the US plant can still manufacture the products but must find other sources for the APIs,” a spokesman from parent company Daiichi-Sankyo told in-Pharmatechnologist.com, adding at present the facility also uses third-party API suppliers to support production.
When asked whether the import ban would cause a shortage of finished products, he said: “We cannot say yes or no” but ramping up resources “from third parties is one option.” However, the spokesman added neither Daiichi-Sankyo nor Ranbaxy had decided on a course of action yet.
FDA’s Action
The FDA’s actions were justified as “taking swift action to prevent substandard quality products from reaching US consumers,” according to acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research Carol Bennett.
The inspection noted a number of GMP violations at the site, including Toansa staff retesting raw materials, intermediate drug products, and finished API after those items failed analytical testing and specifications, in order to produce acceptable findings, and subsequently not reporting or investigating these failures (click here to view the 483).
In a statement from Ranbaxy this morning the firm said it had voluntarily suspended shipments of APIs from the facility bound for the US market after receiving the 483 and it was disappointed with the FDA’s action.
CEO Arun Sawhney added: “This development is clearly unacceptable and an appropriate management action will be taken upon completion of the internal investigation.”
We asked Daiichi-Sankyo what it would be doing to help resolve Toansa’s problems. The spokesman “could not comment on any concrete procedure for solving this problem” but in the past staff had been dispatched from Japan to assist with its subsidiary’s facilities.
