Key Points
Reddys Laboratories said it has introduced Regadenoson Injection 0.4 mg/5 mL, a generic therapeutic equivalent of Astellas US LLCs Lexiscan (Regadenoson) injection, in the U.S. market. ..
Dr. Reddys Laboratories has been issued a Form 483 with one observation by the United States Food and Drug Administration following an inspection of the companys active pharmaceutical ingredient (API) manufacturing facility in Bollaram, Hyderabad...
Through Form 483, the U.S. FDA notifies the management of the company whose facility it inspected of objectionable conditions observed by its officials that may constitute violations of the Food Drug and Cosmetic Act and related Acts. ..
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