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United States Food and Drug Administration issued Form 483 to Dr. Reddys Laboratories Vizag

In a setback for city - based pharma player, Dr Reddys Laboratories (DRL), two of its units in Andhra Pradesh have come under the US drug regulators scanner.The company informed the bourses that its two formulations manufacturing units in Visakhapatnam - Vizag SEZ Plant 1 and Vizag SEZ Plant 2 at Duvvada have been issued Form 483 with two observations by the United States Food and Drug Administration (USFDA). The audit of these two plants were completed on June 21, 2019. "We have been issued a Form 483 with two observations. We will address them comprehensively within the stipulated timeline," the company informed the bourses. According to the USFDA website, Form 483 is issued to a company at the conclusion of an inspection when investigators observe any conditions that, in their judgement, may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The company also announced the launch of Phytonadione Injectable Emulsion USP 10 mg/ml single - dose ampules, which is used to treat vitamin K deficiency or bleeding problems caused by various disorders, in the US market. The drug is a generic version of Vitamin K1 (Phytonadione) Injectable Emulsion USP, 10 mg/ml, approved by the FDA. According to industry estimates, the Vitamin K1 (Phytonadione) for Injectable Emulsion USP, 10 mg/ml brand and generic had logged combined US sales of approximately Rs. 46.6 million for the 12-month ending April.

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