Drug-maker Ranbaxy Laboratories received a regulatory communication from the US Food and Drugs Administration (USFDA) about its plant in Toansa, Punjab, on Saturday.
Ranbaxy confirmed that it had received a Form 483 (observations made following an inspection) from the USFDA on its active pharmaceutical ingredients (API) plant in Toansa.
“The company is assessing the observations, and will respond to the USFDA, in accordance with the agency’s procedure, to resolve the concerns at the earliest,” said a company spokesperson.
The company’s stock price took a beating on the development, hitting a low of Rs 426 after dipping 8 per cent during the day. The stock closed at Rs 438, down 5.42 per cent, on Monday.
Two of Ranbaxy’s plants — Paonta Sahib (Himachal Pradesh) and Dewas (Madhya Pradesh) — have been under import restrictions since 2008. Another plant in Mohali, Punjab, also attracted an import alert from the USFDA in September 2013.
This is not the first time violations have been found at the Toansa facility. The USFDA had identified at least eight violations in the plant in December 2012. The latest Form 483 could potentially add to Ranbaxy’s problems. If corrective actions are not taken at the Toansa plant, the company could get another warning letter or an import alert, hurting its US revenues.
Sarabjit Kour Nangra, Angel Broking’s Vice-President, Research (Pharma), said: “With this plant (Toansa) also under the scanner, there will be an impact on the operations of the company in the US, unless it can compensate for the same at the earliest and manage a smooth supply of key raw material.”
She added that the Toansa plant is estimated to supply 70-75 per cent of Ranbaxy’s APIs and a scrutiny could potentially affect the company’s operations in the US. “It (Toansa plant) is critical in terms of material supply for the US (market),” she said.
aesha.datta@thehindu.co.in