Wockhardt announced that U. S. Food and Drug Administration ('USFDA') has carried
out inspection of Bioequivalence Centre located at R&D Centre, Aurangabad during which
Bioequivalence studies of Tamsulosin 0.4mg capsules and Metoprolol Tartrate 200mg ER tablets
were audited. At the end of inspection, there was Nil observation (i.e. zero 483 observation),
signifying that best practices were followed, in compliance to applicable regulations. This outcome
would lead approvals of ANDAs in pipeline for which Bioequivalence studies are being or will be
done in the said Centre.
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