Germany's Fresenius Recalls India-made Drugs Shipped to US.

NEW DELHI: German drugmaker Fresenius Kabi has started voluntary recall of two batches of a shipped to the US, made by its Indian subsidiary Fresenius Kabi Oncology  after it found cross contamination. The drug sold as anastrozole tablets is used to treat breast cancer and is sold in the US through Fresenius Kabi’s local unit APP Pharmaceuticals. The drug made at Fresensius Kabi Oncology's plant in Baddi (Himachal Pradesh) was launched just three months ago. Fresenius Kabi Oncology, formerly known as Dabur Pharma, was acquired by the German firm from Burmans of Dabur Group in 2008.

The firm informed the US drug regulator about the recall on September 1, the US Food and Drug Administration (FDA) said on its website. The company found other medicines in some of the bottles containing anastrozole tablets of 1 mg dosage, it said. Fresenius Kabi is recalling 7,192 bottles, each bottle containing 30 1-mg tablets, which expires in May next year. The financial implications of the recall could not be immediately ascertained. Fresenius Kabi did not respond to an e-mail query over the weekend. But a person close to the company said it was an isolated case of some other drug mixing up in few bottles containing anastrazole.

The company is recalling both the batches as a precautionary measure and there will be no material financial impact from the recall. So far, there has also been no complaints of adverse effects from patients and there is no quality problem with the drug, he said, asking not to be named. Sapna Jhawar, an analyst with brokerage firm Sharekhan, estimates a moderate financial impact since the market is big and there are limited players in the oncology space. Besides, Fresenius will not be able to regain the market quickly as competitors would fill in the gap left by the recall. “There will be a sentimental impact on the share price,” Ms Jhawar said.

The Delhi-based drugmaker’s share price closed at Rs 137.4, up 1.1% at the Bombay Stock Exchange on Friday. The total size of the market for the medicine was $917 million in 2009 in the US, APP Pharmaceuticals had said, quoting market research firm IMS in a release at the time of its launch of its drug in June end. Around 105 million anastrozole tablets are sold annually in the US, the release added. Fresenius Kabi is recalling around 0.2 million tablets.

The medicine was originally made by Anglo-Swedish drugmaker AstraZeneca who sold it under the brand Arimidex.

Fresenius Kabi had acquired the Delhi-based cancer drugmaker by buying out the Indian promoters shares two years ago. The German drugmaker had soon thereafter acquired APP Pharmaceuticals.

The German drugmaker plans to use the low-cost manufacturing facilities of the Indian company and sell its products globally. Although product recalls are common globally, such developments related to Indian drugmakers have come under the spotlight, specially after 30 drugs made by the country’s largest drugmaker Ranbaxy at its two Indian plants have been banned for manufacturing lapses. Sun Pharma has also got two warning letters for manufacturing lapses at two of its overseas plants.

Other drugmakers such as Lupin, Cipla and Dr Reddy’s have also been found wanting in their manufacturing plants during inspections by the FDA. But they have managed to come clean.

Source : economictimes.indiatimes.com