Drug companies eye US entry after FDA checks

Posted By: Religare
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Drug companies eye US entry after FDA checks
The US Food and Drug Administration (FDA) has conducted inspections of manufacturing facilities of several Indian pharmaceutical companies. The US FDA officials are reportedly satisfied with the manufacturing facilities of Indian drug companies, such as Ranbaxy Laboratories, Orchid Chemicals, Emcure Pharma, Nectar LifeSciences and Ind Swift Laboratories.

The inspections were carried out during the last four weeks, and the drug plants have been found to be in conformity with the stringent US regulations. The US FDA approval has led to expectations that, these drug makers would be allowed to export their drugs to the US, which is the world's largest drug market.

With the FDA approval, Ranbaxy and Nectar can start exporting their medicines to the US for the first time from these manufacturing facilities. For Orchid Chemicals, Emcure Pharma and Ind Swift Laboratories, the nod means that they can keep exporting drugs to US from their plants .The FDA carries out examinations at the Indian drug makers' manufacturing facilities, to check whether the drugs produced at these plants are safe for consumption by the American people. Only on its approval, the medicines can be sold in the US market.

The US is set to give the go ahead for the sale of generic medicines in the country, in a bid to lower costs and increase the access of these drugs to all the citizens. With patents of many best selling drugs worth $30-40 billion ,such as Lipitor ( Pfizer ), Nexium (Astra Zeneca) and Plavix ( Bristol Myers Squibb) set to expire in the next one to two years , generic drugs which are priced at one -tenth of the patented brands ,will be allowed to be sold in the US market.

Ranbaxy, India's largest drug maker by sales would stand to gain the most from the FDA nod, as a quarter of its total revenue comes from the US market. Following the approval, the firm would be able to export drugs to the US for the first time from its Indian facilities since 2008, when the FDA banned the company's exports from its two manufacturing facilities at its Poanta Sahib (Himachal Pradesh) and Dewas plant (Madhya Pradesh).The FDA has not found any deficiency in its new Mohali (Punjab) plant after a two week inspection.

Chandigarh based Nectar Lifesciences can start selling its active pharmaceutical ingredient (API) drugs in the US, following an official approval from the US regulator of its Dera Bassi plant. Ind Swift, another Chandigarh based drug maker can continue exporting to the US after its Dera Bassi facility was found to be in line with US norms following a four day inspection.

Orchid Chemicals, the Chennai based drug maker, received approval in June this year from the FDA for continuing to export its cephalosporin API drugs to US and other developed nations. Emcure's Pune plant was inspected by US officials for the third time. Indian Pharma companies like Ranbaxy, Dr Reddy's, Sun Pharma and Aurobindo have faced penalties and bans in the past, for not complying with US norms.US contributes one fourth to India's total 50,000 crore drug market.

Story first published: Wednesday, July 6, 2011, 10:30 [IST]
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