Cadila Healthcare has informed that with reference to news appearing in the media this morning, they wish to clarify that this matter very specifically relates to an Untitled Letter issued by the USFDA to Zydus Discovery DMCC (a 100% subsidiary of Cadila Healthcare) and not a Warning Letter. The letter is related to a product promotion of a drug which is not marketed in USA and currently marketed only in India. We have already taken the necessary actions to respond to this letter. As per the USFDA website, ‘Unlike a warning letter, an Untitled Letter does not include a statement warning that failure to promptly correct a violation may result in an enforcement action’.
The above information is a part of company’s filings submitted to BSE.
