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    Zydus Lifesciences bags USFDA nod for pulmonary drug Roflumilast

    Ahmedabad: Pharma major, Zydus Lifesciences Limited, has announced that the company has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Roflumilast Tablets, 250 mcg (USRLD: Daliresp Tablets, 250 mcg). Roflumilast reduces inflammation in the lungs which leads to chronic obstructive pulmonary disease (COPD). It is used to […] More

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    Lupin Gets CDSCO Panel Nod for Phase IV CT of pulmonary FDC drug

    Lupin Gets CDSCO Panel Nod for Phase IV CT of pulmonary FDC drug

    New Delhi: Pharmaceutical major, Lupin has got the go ahead from the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) to conduct a Phase IV clinical trial of the fixed-dose combination Mometasone furoate plus Glycopyrronium bromide plus Indacaterol acetate Inhalation Powder This came after the firm presented the Phase IV clinical […] More

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    CDSCO panel grants approval to Akums for PK study of pulmonary FDC

    CDSCO panel grants approval to Akums for PK study of pulmonary FDC

    New Delhi: Citing that the pharmacokinetic study should be presented before the committee for review, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted approval to drug major Akum Pharmaceutical to conduct the pharmacokinetic (PK) study for the fixed-dose combination of the pulmonary drug, Levosalbutamol Sulphate plus Ambroxol […] More

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    Glenmark gets CDSCO panel nod to manufacture ,market pulmonary FDC drug

    Glenmark gets CDSCO panel nod to manufacture ,market pulmonary FDC drug

    New Delhi: The drug major Glenmark has got the go ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market a fixed dose combination pulmonary drug, which each capsule contains Indacaterol (as acetate) equivalent to Indacaterol 150 mcg, Glycopyrrolate IP equivalent to glycopyrronium 50 mcg, […] More