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The FDA issued a warning letter to an Indian API manufacturer after inspectors found that the company knowingly accepted deliberately mislabeled raw materials to bypass licensing requirements, failed to perform required identity testing, and relied on unverified supplier documentation before using the materials to manufacture APIs shipped to the United States
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Reconstitution: 3.0 mL per 30 mg vial (10.0 mg/mL) all doses fit in a single syringe
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