Mumbai | Posted: September 18, 2014 4:35 am
Natco Pharma and Orchid Chemicals and Pharmaceuticals have received an adverse observation report, commonly known as Form 483, after inspections conducted in their manufacturing units earlier this year by the US Food and Drug Administration, according to documents reviewed by FE.
Natco, which was in news for battling Teva Pharmaceutical Industries over the patent of the latter’s multiple sclerosis drug Copaxone, was issued the Form 483 dated May 23 after a five-day inspection of its finished dosage facility located in Mahabubnagar district in Telangana.
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