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7.12.16

Sun Pharma Slumps As BSE Seeks Clarification On USFDA

Sun Pharma shares fall as much as 4.6% after FDA inspects company’s Halol plant
US FDA has given a 14-page inspection report on Sun Pharma’s Halol plant that could list potential violations of the agency’s manufacturing guidelines

Mumbai: A US Food & Drug Administration (FDA) inspection of Sun Pharmaceutical Industries Ltd’s facility in Halol, India, has given rise to a 14-page inspection report that could list potential violations of the agency’s manufacturing guidelines.
The report, a Form 483 which lists observations that may constitute regulatory violations, is currently under review and will be available by the end of the week, the FDA said in a response to a Freedom of Information request. Sun Pharma shares dropped as much as 4.6% in Mumbai trading Wednesday.
The regulator didn’t give details or any indication of the seriousness of the observations. The drugmaker will have a chance to respond to the observations before a final determination is made, according to the FDA’s website.
Sun’s Halol plant received a warning letter last year from the regulator due to past violations which has prevented new product launches from the facility in the US, Sun’s largest market. That has slowed revenue growth at India’s largest drug maker and imposed new costs to bring the plant back up to standard. The latest US FDA inspection came after Sun invited the agency back to review a year’s worth of remediation efforts in the hopes the warning letter would be lifted. Frederick Castro, a spokesman for Sun Pharma, declined to comment on the US FDA observations. Bloomberg
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