New Delhi, May 3 (IANS) Pharmaceutical major Alkem Laboratories has come under regulatory scrutiny after the United States Food and Drug Administration (USFDA) issued inspectional observations at its manufacturing facility in Amaliya, Daman, following a recent audit.The inspection, conducted over 12 days from April 20 to May 1, concluded with the issuance of a Form 483, in which the US regulator flagged seven observations.A Form 483, formally known as a “Notice of Inspectional Observations,”…
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Boston, May 1 (IANS) India’s emergence as a global pharmaceutical powerhouse is entering a new phase, driven by innovation, vaccine leadership and expanding clinical capabilities, according to Dr Elias Zerhouni, former Director of the US National Institutes of Health (NIH).Zerhouni said the India-US relationship in healthcare and biotechnology has steadily strengthened over the years, moving beyond manufacturing to innovation-led collaboration.“There’s a tremendous amount of exchanges and …
New Delhi, April 18 (IANS) Major drug maker Lupin on Saturday said that the US health regulator has issued a ‘Form 483’ with three observations to its manufacturing facility in Somerset, New Jersey, following a recent inspection.In a regulatory filing, the pharmaceutical company said that the inspection by the US Food and Drug Administration (USFDA) was conducted this week between April 13 and April 17.”The inspection was completed with the issuance of a Form 483 carrying three observations,” th…
New Delhi, April 15 (IANS) Healthcare companies in India are expected to deliver high single-digit revenue growth (year-on-year) in the fourth quarter of FY26 (Q4 FY26), a report showed on Wednesday.However, EBITDA margins will materially be corrected, according to the report by Systematix.“Median growth is estimated at 12 per cent for revenue and 3.6 per cent for EBTIDA, with net earnings likely witnessing a 14 per cent decline, the report mentioned.The primary driver of this on-year decline …