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  • Duty of regulatory agencies must be to prevent harm from unsafe drugs, Kim Huynh-Ba.

    The primary duty of the regulatory bodies across the world is to prevent harm from unsafe drugs. In the United States, the law ensures that there shall be a written stability testing programme to assess the stability characteristics of drug products. Stability is the critical quality attribute of a drug product. Further it ensures the capacity of a drug substance, said Kim Huynh-Ba, Technical director of Pharmalytik, Newark in USA.

  • Several drugs to come under regulatory scanner as national pharmacovigilance programme to begin in April

    Two H1N1 drugs - oseltamivir and zanamavir, the controversial sub-fertility drug letrozole, popular non-steroidal anti-inflammatory drug nimesulide, decongestant drug phenylpropanolamine (PPA), antibiotic drug gatifloxacine, chronic constipation drug tegaserod, type-2 diabetes drug pioglitazone and rosiglitazone have been selected for the first phase of national pharmacovigilance programme which will begin in select 40 medical colleges across the country from April this year.

  • GVK Bio opens new clinical pharmacology unit in Ahmedabad

    GVK Biosciences, a contract research organization, has commissioned its new clinical pharmacology unit (CPU) in Ahmedabad. The facility adds 110 beds to the company's existing capacity of 144 beds and will conduct a range of tests on healthy volunteers.

  • FDA Approves New Somatropin Injection Pen for Growth Hormone Disorders

    March 5, 2010 — The US Food and Drug Administration (FDA) has approved a prefilled somatropin (rDNA origin) injection pen (Norditropin FlexPro, Novo Nordisk, Inc) for the treatment of growth hormone disorders in adult and pediatric patients. The product, an updated version of the company's NordiFlex pen introduced in 2004, is expected to be available in the second quarter of 2010.

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  • Haffkine Institute to establish BA/BE study centre soon

    The more than 100-year old Haffkine Institute of Mumbai will soon establish a BA/BE study centre which will be useful to the pharma industry in India and abroad in getting a more authentic bioavailability and bioequivalence (BA/BE) study results. The government-controlled Institute has already started the process in this regard and is expected to be completed within a year's time.

  • Himalaya enters chronic respiratory allergy segment with Bresol

    The Himalaya Drug Company has ventured into cough suppressants space with the launch of Bresol, a breathing solution for treating chronic respiratory allergies. Bresol will be an ethically promoted product from the company's Pharma division.

  • Gujarat FDCA appoints 156 staff in one go to avoid backlog in samples testing

    The Gujarat Food and Drug Control Administration (FDCA) has completed a mass recruitment process in the first week of March by giving away appointment letters to 156 candidates in one go, probably the biggest recruitment since the inception of the administration, in a move to hasten the monitoring activities of food and drugs marketed in the state.

  • DoP calls meeting on March 2 to discuss MS Pharmacy issue

    Even as hundreds of MS (Pharmacy) students of all the NIPERs in the country are on a silent strike to put pressure on the authorities to resolve the issues arising out of the PCI's recent decision not to recognize the MS programme in Industrial Pharmaceutics and Pharmaceutical Analysis & Quality Control, the department of pharmaceuticals (DoP) has called a meeting on March 2 to discuss the issue in threadbare.

  • Govt to constitute National Apex Committee for monitoring stem cell research soon

    Almost two years after announcing the Guidelines for Stem Cell Research Regulation, prescribing stringent procedures for souring and use of stem cells by research institutions in the country, the union health ministry is yet to constitute the National Apex Committee (NAC) for effectively reviewing and monitoring the stem cell research in the country.

  • INTERPHEX Asia to be held in Singapore on June 7

    INTERPHEX Asia, a platform for showcasing latest technologies and expertise to the pharmaceutical and biopharmaceutical industry players in Asia will be held at Suntec International Convention & Exhibition Centre , Singapore on June 7 & 8, 2010.

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