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ShareMumbai: Mumbai-based drugmaker Lupin expects to resolve the issues the US Food & Drug Administration (FDA) has raised over its facility in Mandideep, Madhya Pradesh, in 4-5 months.
In November 2008, the FDA had issued 15 non-compliance observations (483s) to the drugmaker for its Mandideep manufacturing facility near Bhopal. In May this year, the US regulator issued Lupin a warning letter, saying the drugmaker's responses on some non-compliance issues weren't satisfactory.
A top company official said the management's meeting with the FDA last month went off well. "We expect a re-audit in the next 2-3 months and the matter will be resolved soon," the official said.
In an earlier interview, Kamal K Sharma, managing director, Lupin, had said the company had a three-pronged strategy -- strong conviction, expert advice from world-class consultants, and coordination with the FDA -- to deal with the issue.
A key market for the Rs 3,800 crore company, the US accounted for sales of Rs 1,189 crore in financial year 2008-09, a year-on-year growth of 65%.
Analysts said the FDA issue hasn't had a major impact on Lupin's business as only one product has been affected. The supplies of other products, which contribute Rs 350 crore to the company's revenues, continue as usual.
Lupin is looking to expand its US presence to specialty areas such as allergy and asthma, which are somewhat similar to its key therapeutic area -- paediatrics.
A senior research associate with a broking firm in Mumbai said Lupin could acquire brands or get into licensing agreements in these categories, in turn reducing dependence on its key product Suprax.
