Pharma News

Sun Pharmaceutical Industries Ltd announced that it has received approval from the U.S. Food and Drug Administration (USFDA) for INFUGEM™ (gemcitabine in 0.9% sodium chloride injection) 10 mg/mL, for intravenous use in a ready-to-administer (RTA) bag. This is the first USFDA approval for a product from Sun Pharma’s Halol facility post receipt of Establishment Inspection Report (EIR) in June 2018.

FDA considering all options for positively impacting both access and the cost of health care. FDA announcing a new effort to establish innovative approaches to increase access to a broader selection of nonprescription drug products for consumers, empowering them to self-treat common conditions and potentially some chronic conditions.

The Union Cabinet chaired by the Prime Minister Shri Narendra Modi has given its ex-post facto approval for the Memorandum of Understanding (MoU) between the Central Drugs Standard Control Organization (CDSCO), India and National Agency for Drug and Food Control (BPOM), Indonesia on cooperation in the field of pharmaceutical products, pharmaceutical substances, biological product and cosmetics regulatory functions.
The MoU was on signed on 29th May, 2018 in Jakarta.

The Union Cabinet chaired by Prime Minister Shri Narendra Modi has given its ex-post facto approval for the Memorandum of Understanding (MoU) between India and Cuba on cooperation in the field of Traditional Systems of Medicine and Homeopathy.  The MoU was signed on 22.6.2018.

The European Union (EU) and Japan have agreed to broaden the range of medicines for which they will recognise each other’s inspections of manufacturing sites.

The current mutual recognition agreement (MRA) between the EU and Japan has been operational since 29 May 2004. It allows regulators to rely on good manufacturing practice (GMP) inspections in each other’s territories, to waive batch testing of medicines that enter Japan from EU countries and vice versa and to share information on inspections and quality defects. Thanks to this agreement, regulatory authorities in the EU and Japan can make better use of their inspections resources by reducing duplication of inspections in each other’s territory.

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Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Colesevelam Hydrochloride for Oral Suspension, 1.875 grams/Packet and 3.75 grams/Packet, the generic version of Welchol®1 for Oral Suspension, 1.875 grams/Packet and 3.75 grams/Packet, of Daiichi Sankyo Inc.

Omega 3 is a type of fat. Small amounts of omega 3 fats are essential for good health, and they can be found in the food that we eat. The main types of omega 3 fatty acids are; alpha­linolenic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA). ALA is normally found in fats from plant foods, such as nuts and seeds (walnuts and rapeseed are rich sources). EPA and DHA, collectively called long chain omega 3 fats, are naturally found in fatty fish, such as salmon and fish oils including cod liver oil.

A class of molecules formed when the body metabolizes omega-3 fatty acids could inhibit cancer's growth and spread, University of Illinois researchers report in a new study in mice. The molecules, called endocannabinoids, are made naturally by the body and have similar properties to cannabinoids found in marijuana - but without the psychotropic effects.

A novel drug based on capsaicin, the compound that gives chili peppers their spicy burn, caused long term weight loss and improved metabolic health in mice eating a high fat diet, in new studies from the University of Wyoming School of Pharmacy. The drug, Metabocin, was designed to slowly release capsaicin throughout the day so it can exert its anti-obesity effect without producing inflammation or adverse side effects.

Apotex, Canada’s largest generic pharmaceutical company, has signed an agreement to sell its commercial operations and certain supporting infrastructure for its generics business in five European countries to Aurobindo Pharma Limited. The sale will allow Apotex to focus its resources on the Americas where strong demand for its portfolio continues.