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HomeNewsBusinessStocksAlembic Pharma shares gain on EIR from USFDA for Panelav unit

Alembic Pharma shares gain on EIR from USFDA for Panelav unit

Alembic Pharmaceuticals Share Price | USFDA issued EIR to the company post inspection conducted between May 26-31.

September 15, 2025 / 09:21 IST
Alembic Pharmaceuticals
     
     
    26 Aug, 2025 12:21
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    Alembic Pharmaceuticals share price rose in the opening trade on September 15 following the company received establishment inspection report (EIR) post inspection by the US Food and Drug Administration (USFDA).

    At 09:20am, Alembic Pharmaceuticals was quoting at Rs 953.90, up Rs 8.10, or 0.86 percent, on the BSE.

    ".... has EIR today for the inspection carried out conducted from 26th May, 2025 to 31st May, 2025 by USFDA at its API - I & API - II facility located at Panelav.

    Last week, the company received final approval from the USFDA for its abbreviated new drug application (ANDA) Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe.

    Phytonadione Injectable Emulsion is use for the treatment of hypoprothrombinemia due to vitamin K deficiency or interference.

    In August, the company received final approval from USFDA for its ANDA Macitentan Tablets, 10 mg, which is use for treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH. Refer label for a detailed indication.

    Catch all the market action on our live blog

    The share touched a 52-week high of Rs 1,296.15 and a 52-week low of Rs 725.60 on 09 October, 2024 and 03 March, 2025, respectively.

    Currently, the stock is trading 26.41 percent below its 52-week high and 31.46 percent above its 52-week low.

    The market capitalisation of the company stands at Rs 18,750.16 crore.

    Moneycontrol News
    first published: Sep 15, 2025 07:43 am

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