Lupin expects USFDA re-inspection at plant

Lupin expects USFDA re-inspection at plant
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First Published: Wed, Jul 29 2009. 04 51 PM IST
Updated: Wed, Jul 29 2009. 04 51 PM IST
Mumbai: Drugmaker Lupin expects US Food and Drug Administration to reinspect its manufacturing unit in Madhya Pradesh and is scouting for a India buyout worth up to Rs300 crore, a company official said on Wednesday.
Last year, the regulator found 15 deficiencies at Lupin’s Cephalosporin making plant in Madhya Pradesh.
“We had a meeting with the FDA, no new issues were raised. They will come for a new inspection,” said Nilesh Gupta, group president and executive director, Lupin without mentioning the inspection date.
The FDA’s action did not have any effect on company’s revenue from the plant, which contributes about 30% of its Rs300 crore sales in US, he said.
“There hasn’t been any business impact, but it is a problem and we have to deal with it.”
Following a warning letter about the 15 deficiencies at Lupin’s plant, the US regulator had confirmed two of Lupin’s facilities were in compliance with the manufacturing standards, he said.
“We are using this warning letter as a wake-up call and looking we could be better.”
Capex, acquisition plans
The company would invest about Rs450-500 crore in 2009-10 to upgrade and expand its facilities, Gupta said.
The company will also scout for a drug making plant in India and is willing to spend about Rs300 crore in addition to the 2009-10 capex, a company spokesperson said.
The funds for capital expenditure and the likely buy-out will come from internal accruals, the spokesperson added.
The company continues to look out for a brand buy-out in the US, besides marketing companies in Latin America, middle East and Eastern Europe, Gupta said.
In March, Lupin bought 51% stake in Multicare Pharmaceuticals Philippines Inc.
Earlier in the day, the company reported a 65% rise in April-June net profit on year, driven by its robust formulation sales in the US and domestic markets, Gupta said.
Shares in the company ended down 0.44% to Rs944.40 in a weak Mumbai market that closed down 1.03%.
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First Published: Wed, Jul 29 2009. 04 51 PM IST
More Topics: Lupin | USFDA | Capex | Cephalosporin | Corporate News |