The US Food and Drug Administration has found 15 manufacturing deficiencies at Lupin plant in Madhya Pradesh during the course of a two-week inspection, which concluded on Wednesday. Reports said the findings could invite stronger sanctions if the company fails to address the deviations addressed by the FDA.
However, its was also clarified that the findings are not as serious as the ones unearthed at the plants of Ranbaxy and Sun Pharmaceuticals, which led to the ban of product supplies from these plants.
Meanwhile, the pharma giant said it has already met eight of the observations made by FDA and would move quickly on others. In a release to the stock exchanges, Lupin clarified that the FDA completed an inspection of its manufacturing facility in Mandideep, India and said it was a routine Good Manufacturing Practices (GMP) audit.
While inspection report (FDA-483) was issued listing 15 inspectional observations, Lupin said it has addressed and presented its action in response to eight of these observations right away. A complete response to all the observations will be submitted to the FDA expeditiously, the company said.
"The outcome of this inspection does not affect the supply of products manufactured at this facility to markets across the world, or the approvability of pending applications with the US FDA. Lupin continues to manufacture and test all produces in accordance with US FDA requirements, " Lupin pointed out.
The Mandideep facility was earlier inspected in 2003 and 2006. In 2003, the company received 9 inspectional observations, following which, the company addressed the issues to the satisfaction of FDA. In 2006, however, the inspection didn't reveal any observations.
The Mumbai headquartered Lupin is engaged in manufacturing active pharmaceutical ingredients and formulations. The company reported a net profit of Rs115.62 crore for the second quarter ended September, 52.85% growth over the corresponding period a year ago. The total consolidated income rose to Rs. 934.31 crore from Rs. 673.99 crore in the same quarter last year.
On the Bombay stock exchange, Lupin is trading at Rs.588.05, down 3.38% on a volume of 36,278 shares. The stock hit a high of Rs.604.45 and a low of Rs 571 so far during the day. It has delivered negative returns of 14.86% and 17.39% over the last one-week and a month respectively.
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