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The company believes that the warning letter will have minimum impact of disruption of supplies and the existing revenues from operations of this facility.
Shilpa Medicare ventured into the OTC segment with the launch of ‘ready-to-drink’ green tea films. The company is marketing it as an immunity booster as well.
The company’s abbreviated new drug application (ANDA) for Dimethyl Fumarate delayed release capsules in the strengths of 120 mg and 240 mg has been granted tentative approval by the United States Food and Drug Administration (US FDA), Shilpa Medicare said