Cadila Healthcare, a Ahmedabad headquartered pharmaceutical company owned by Zydus Group, said it has partnered with Switzerland-based global biopharmaceutical company Neovii to launch an drug to reduce the strength of the body’s immune system in India. The drug named Grafalon is extensively used in solid organ transplants and stem cell transplant, said the company. The […]
Alembic Pharmaceuticals Ltd., said it received an Establishment Inspection Report from the United States Food and Drug Administration for the inspection carried out at their formulation facility at Panelav, Gujarat. The FDA has the authority to inspect any establishment in which food is manufactured, processed, packed, or held, in search of contamination. Upon completion of […]
Shilpa Medicare Ltd said it received an approval from the United states Food & Drug Administration for Azacitidine injection. Azacitidine is used to treat myelodysplastic syndrome – a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells. The approval was received under […]
USFDA issued four observations about Cipla’s manufacturing facilities in Goa after conducting an audit, the company said. Cipla has three facilities in Goa. “The observations were primarily procedural in nature and the company has already responded to these observations,” said the pharma company. Further details were not given. The company said it will continue to operate their […]
Pharma Major Lupin Ltd said it received final approval from United States Food and Drug Administration for selling Memantine Hydrochloride extended-release capsules, a generic version of Allergan’s Namenda XR capsules. Namenda XR extended-release capsules are approved by the USFDA for the treatment of moderate to severe dementia of the Alzheimer’s disease. It does not cure […]
Kilitch Drugs (India) Ltd said its unit Kilitch Estro Biotech Plc acquired land for the installation of a pharma plant in Ethiopia. 4317.5 sq. mtrs of land was allotted at Oromia special zone by the Bureau of Rural Land and Environmental Protection, Federal Democratic Republic of Ethiopia on lease for a period of 45 years. […]
Drug manufacturer Suven Life Sciences Ltd said it got two product patents in India and Japan for to a new compound for the treatment of disorders associated with Neurodegenerative diseases. The patents are valid through 2026-2032. The granted claims include a class of selective 5-HT6 compounds and H3 inverse agonist compounds and are being developed as […]
Marksans Pharma Limited, an Indian pharmaceutical company, said it has received approval from the USFDA for the sale sale of its Loratadine Liquid Filled Capsules 10 mg in the US market. Loratadine is an antihistamine that reduces the effects of natural chemical histamine in the body and is used to treat sneezing, runny nose, watery […]
Lincoln Pharmaceuticals Ltd said it developed and launched an oral spray version of Ondansetron anti-nausea drug. Ondansetron is used to prevent nausea and vomiting caused by cancer drug treatment (chemotherapy), radiation therapy and also in the prevention and treatment for nausea and vomiting after surgery. The medication is also more helpful during motion sickness. Presently […]
Aurobindo Pharma Limited, a pharmaceutical manufacturing company based in Hyderabad, said it received a tentative approval for HIV drug Dolutegravir from US Food & Drug Administration. It is the first FDA approval of a generic version of Dolutegravir. Through a tie up with ViiV and the Clinton Health Access Initiative, Inc., the product is expected […]
Syngene International Ltd., Asia’s largest contract research organization, said it has purchased assets of Strand Life Sciences related to systems biology, Heptox and Pharma Bioinformatics services. Financial details of the deal were not disclosed. The acquisition includes target dossier business and rights to NGS data analytics and Sarchitect platforms, supported by a strong scientific team. […]
Zydus Cadila, a global healthcare provider, and Takeda Pharmaceutical Company Limited, one of the world´s largest pharmaceutical companies, announced a partnership to develop vaccine for chikungunya, an emerging infectious disease. The broadbased agreement includes early stage development to the final commercialisation of the vaccine against chickungunya. There is currently no vaccine to prevent or medicine to treat […]
Dr. Reddy’s Laboratories Ltd said it launched Paricalcitol Injection, a therapeutic equivalent generic version of Zemplar injection in the United States market approved by the US Food & Drug Administration (USFDA). The Zemplar brand and generic had US sales of approximately $22.5 million for the most recent twelve months ending in July 2016 according to […]
Glenmark Pharmaceuticals, Inc., USA said it has entered into a strategic Development, License and Commercialization Agreement with Particle Sciences, Inc. to develop and market a generic version of Celgene’s Abraxane, used for cancer treatment. As per the terms of the agreement, Glenmark has obtained global exclusive marketing and distribution rights of the product upon commercialization. Particle […]
Opto Circuits, a medical technology group, said its wholly owned subsidiary, Eurocor GmbH, entered the global market with their Freeway coated shunt baloon catheter. Freeway coated shuntbaloon catheter is used for arteriovenous (AV) access to help patients with end-stage renal disease. It also helps to reduce re-intervention and preserves future treatment options. Following the 1st […]
Drug manufacturer Suven Life Sciences Ltd said it got three product patents from Canada, Europe & Hong Kong corresponding to new chemical entity for the treatment of disorders associated with Neurodegenerative diseases. The patents are valid through 2030-2032. According to the U.S. Food and Drug Administration, a new chemical entity (NCE) is a drug that […]
Pharma Major Lupin Limited (Lupin) announced that it received tentative approval from the United States Food and Drug Administration (FDA) for selling Silodosin capsules, a generic version of Allergan Sales’ Rapaflo capsules. Silodosin capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia, or the enlargement of tissue due to […]
Glenmark Pharmaceuticals said its overseas subsidiary has discovered a molecule that can potentially be used in targeting even difficult-to-treat lung cancer and colorectal cancer. The GBR 1372 molecule was discovered in the pharma company’s Swiss laboratory and that the company plans to file an application with the US Food and Drug Administration to approve the […]
Pharma Major Lupin Limited announced that its US subsidiary, Gavis Pharmaceuticals received a tentative approval from the US FDA for selling Moxifloxacin hydrochloride tablets, a generic version of Bayer Healthcare Pharmaceuticals’ Avelox tablets. Lupin’s Moxifloxacin hydrochloride tablets are the AB rated generic equivalent of Bayer Healthcare Pharmaceuticals Inc.’s Avelox Tablets and can be substituted by […]
Pharma Major Lupin Limited announced that its US subsidiary, Gavis Pharmaceuticals LLC., received tentative approval for selling a generic version of Pfizer Inc.’s Zithromax oral suspension from the US FDA. Lupin had earlier received final approval for its Azithromycin Tablets and Azithromycin for Oral Suspension, filed from its Goa plant. Azithromycin per bottle are the […]
