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  • Granules Pharma clears US FDA Audit

    Granules India Limited, announced that Granules Pharmaceuticals, Inc. (GPI), a wholly-owned foreign subsidiary of the company, located in Chantilly, Virginia, USA received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA).

    The GPI facility was inspected by the US FDA from 24th to 28th January 2022 for two of its product applications filed. There were three minor observations during the inspection and GPI had addressed the observations in the stipulated time period.

  • More Than Half of Physicians Have Been Asked By Patients for an Unapproved COVID-19 Treatment

    A new survey from Sermo, a physician-first online community and leader in global HCP insights, found that physicians are facing a challenging onslaught of COVID-19 vaccine and treatment misinformation as reported by 3,600+ doctors around the world.

  • Indian Pharmaceutical industry may replace western manufacturers for Russia, Says envoy

    Indian pharmaceutical companies may replace western manufacturers leaving the Russian market, Russian envoy to India Denis Alipov said.

    "The withdrawal of many Western companies from the Russian market and those niches that have been vacated may actually be occupied by Indian companies in many industries, in particular, in pharmaceuticals," Alipov told the Rossiya 24 broadcaster, as quoted by Sputnik news agency.

  • The immune system is very complicated, but now, it’s on a chip

    To quote veteran science writer Ed Yong’s simple yet extremely accurate words in The Atlantic, “The immune system is very complicated.” As the COVID-19 pandemic had made abundantly clear, science still doesn’t fully understand the sophisticated defense mechanisms that protect us from microbe invaders. Why do some people show no symptoms when infected with SARS-CoV-2 while others suffer from severe fevers and body aches? Why do some succumb to cytokine storms of the body’s own making? We still lack exact answers to these questions.

  • Higher Dose Antibiotic Shown Safe in TB Patients Likely More Effective in Treating Deadliest Form of TB

    A Johns Hopkins Children’s Center-led study in animals suggests that high doses of a widely used antibiotic called rifampin may safely treat and reduce the duration of treatment for the deadliest form of tuberculosis that affects the brain, potentially improving survival rates for patients and decreasing the likelihood of lasting adverse effects of the disease.

  • Draft National Medical Devices Policy 2022 opens for feedback from stakeholders

    The Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers has released on its website, an Approach Paper for the Draft National Policy for the Medical Devices, 2022, inviting feedback and remarks of the Industry and stakeholders, till the 25th of March 2022.  In line with the mandate of promoting aspects of the medical device industry, the Department of Pharmaceuticals, realising the need to have a holistic policy to accelerate growth and explore the potential of the Medical Devices Sector, has published thiz approach paper, after extensi

  • Zydus receives final approval from USFDA for Colestipol Hydrochloride Tablets

    Zydus Lifesciences Ltd has received final approval from the USFDA to market Colestipol Hydrochloride Tablets in the strength of 1mg (US RLD: Colestid). Colestipol hydrochloride tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with primary hypercholesterolemia (elevated LDL-C) who do not respond adequately to diet.

    Colestipol Hydrochloride is a highly complex macro molecule drug substance with little or no systemic absorption.

  • Niramai gets US FDA clearance for SMILE-100 system

    The SMILE-100 System is a breast thermography device that helps healthcare personnel to review, measure and analyse thermally significant indications in the breast region

  • Strides receives USFDA approval for Colchicine Tablets

    Strides Pharma Science Limited announced that its stepdown wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Colchicine Tablets USP, 0.6 mg from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Colcrys® Tablets, 0.6 mg, of Takeda Pharmaceuticals U.S.A., Inc. (Takeda).

  • New tactics for COVID-19 prophylaxis

    The ongoing SARS-CoV-2 pandemic has caused an imminent urge for both antiviral therapeutical drugs and vaccines. While the development of vaccines was accomplished in a remarkably short timeframe, the identification of direct antiviral treatments has progressed comparatively slowly. In the light of the further risk of pandemics in the future, however, there remains need for direct antiviral drugs and treatments. Moreover, emerging immune-evasive, I.e. camouflaged from the immune system, SARS-CoV-2 variants are of concern.

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