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    • Dr Reddys unveils...

    Dr Reddys unveils generic version of Vitamin K1 injection in US

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-06-25T10:52:44+05:30  |  Updated On 16 Aug 2021 3:49 PM IST

    The Vitamin K1 (Phytonadione) for Injectable Emulsion USP, 10 mg/ml brand and generic, had combined US sales of approximately USD 46.6 million MAT for the most recent twelve months ended April 2019 according to IQVIA Health, Dr Reddy's (Dr Reddys) said in a statement.


    New Delhi: Dr Reddy's Laboratories recently announced the launch of Phytonadione Injectable Emulsion USP, 10 mg/ml Single-Dose Ampules, a therapeutic equivalent generic version of Vitamin K1, in the US market.


    "We're pleased to bring this product to market for the customers and patients who will benefit from access to this medicine and who have in the past experienced supply disruptions in the market place," said Marc Kikuchi, CEO, North America Generics, Dr Reddy's Laboratories.


    Read Also: Dr Reddys to sell Tosymra, Zembrace to Upsher-Smith Labs for Rs 765 crore approx

    The Vitamin K1 (Phytonadione) for Injectable Emulsion USP, 10 mg/ml brand and generic, had combined US sales of approximately USD 46.6 million MAT for the most recent twelve months ended April 2019 according to IQVIA Health, Dr Reddy's said in a statement.


    Dr Reddy's Phytonadione Injectable Emulsion USP, 10 mg/ml Single-Dose Ampules is available in 1 ml Ampule containing 10 mg/ml of Phytonadione.


    In a separate regulatory filing, the company said the audit of its Formulations Manufacturing Plants (Vizag SEZ Plant 1 and Vizag SEZ Plant 2) at Duvvada, Visakhapatnam by the USFDA, has been completed on June 21 and it has been issued a Form 483 with 2 observations.


    Read Also: Dr Reddys yields positive results from phase 2b study of new psoriasis drug

    "We will address them comprehensively within the stipulated timeline," Dr Reddy's Laboratories said.


    As per the USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts.

    AmpulesDr ReddyDr Reddy's LaboratoriesDr Reddy's LabsFood Drug and Cosmetic Actgeneric version vitamin K1Injectable Emulsionpharmapharma newspharma news indiaPhytonadionePhytonadione Injectable Emulsion USPtherapeuticUnited StatesUSDVitamin K1
    Source : PTI

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    Medical Dialogues Bureau
    Medical Dialogues Bureau

      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

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