USFDA bans Dr Reddy's Mexico plant’s drugs

07 Jul 2011 Evaluate

Dr Reddy's Laboratories' Indian drug maker received a warning letter from the US Food and Drug Administration (FDA) to its Mexican facility for violating manufacturing standards. FDA has imposed an import ban on products made at this unit of the company. FDA warned the company that failure to correct these violations may see the regulator refuse entry into the United States, a key export market for the firm, of products manufactured at Dr Reddy's Mexican facility.

Recently Dr Reddy’s Laboratories has launched Levofloxacin tablets 250mg, 500mg, and 750mg, a bioequivalent generic version of Levaquin tablets in the US market on June 20, 2011, following the approval by the United States Food and Drug Administration (USFDA) of the company’s Abbreviated New Drug Application (ANDA) for Levofloxacin tablets.

The company’s net profit for the fourth quarter declined by 34.48% at Rs 165.87 crore as compared to Rs 253.16 crore for the corresponding quarter previous year. Its total income increased by 7.11% at Rs 1375.77 crore for the quarter under review from Rs 1284.43 crore in the corresponding previous quarter.

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