Sun Pharma said it has been cooperating with the US regulatory agency and will undertake any new steps necessary so the FDA is satisfied with its remediation of the facility in Halol. The plant assumes significance for the company as it can manufacture injectable products, which are hard to make and hence a niche and lucrative market for drugmakers.
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The company will reply with a detailed plan within the stipulated timeframe, he told analysts, adding that greater clarity would emerge in the coming days on whether the warning letter had taken into account remediation efforts already undertaken by Sun Pharma at the site.
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Indian pharmaceutical giant Sun Pharmaceuticals has received a warning from US FDA for flouting manufacturing standards at its plant in Halol.
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“Sun Pharma has always ensured that its products are safe and effective and there is no doubt on the safety of our products in the market”, managing director Dilip Shanghvi said in a statement issued on Saturday.
However, such a warning letter suggests the company is still months away from getting its plant cleared by the FDA, and the regulatory administrators could ban all drug imports from the plant if Sun Pharma fails to fix issues there, states Hindustan Times.
He said the company was also putting together an internal task force to assess how to respond to the issues raised.
The stock too trades nearly 35 percent lower (CMP Rs 790) compared to its peaks of Rs 1,200 in April 2015.
MUMBAI India’s largest drugmaker Sun Pharmaceutical Industries Ltd’s shares opened down 6.4 percent on Monday, after the U.S. Food and Drug Administration issued the firm a warning letter on its key Halol manufacturing plant in western India.
Those drug makers supply close to 40% of the medicines that are sold across the U.S. The situation will continue until the problems are fixed, Mr Shanghvi said.
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The release said that, since the inspection in September 2014, Sun Pharma had communicated regularly with the US FDA on the progress of its remediation and on issues of product supply. The letters are usually posted on the agency’s website a week after they are sent to the manufacturer.
