USFDA letter to Sun Pharma's response on the import alert on its karkhadi plant - Angel Broking

Views of Ms. Sarabjit Kour Nangra (VP Research - Pharma, Angel Broking)

USFDA letter to Sun Pharma's response on the import alert on its karkhadi plant:

"The US Food and Drug Administration (FDA), in a letter dated May7, 2014 warned Sun Pharmaceutical the responses given by it on the import alert on its Karkhadi plant in Gujarat lacked sufficient corrective actions. USFDA officials said the company was found wanting on fundamental raw data necessary to document its analyses. In March, the FDA had issued an import alert, banning formulations and active pharmaceutical ingredients from the factory. USFDA has said it may withhold approval of any new applications or supplements listing at firm's Karkhadi plant as a drug product or an API manufacturer until all corrections have been completed and USFDA has confirmed corrections of the violations and deviations and Sun's compliance with CGMP. Sun was also asked to notify in writing of the specific steps that the company has taken to correct and prevent the recurrence of violations, within fifteen working days of receipt of this letter. Though the said plant contributes negligible to the overall sales of the company, we believe this feedback can delay the clearance process for the company. We maintain our accumulate on the stock with a price target of Rs. 643."

Source : Equity Bulls

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