Lupin launches generic antidepressant in the US

India’s second biggest pharmaceutical company Lupin said it has launched the generic version of Valeant’s Wellbutrin antidepressant tablet Wellbutrin XL in the US. Wellbutrin XL tablet has yearly US sales of USD 758 million or about Rs 5,000 cr. It is used for the treatment of major depressive disorder (MDD) and prevention of seasonal affective […]

Strides Shasun gets USFDA approval for ibuprofen

Pharmaceuticals manufacturer Strides Shasun said it received approval from the United States Food & Drug Administration (USFDA) for ibuprofen Tablets 200 mg for over the counter sales. According to Ri data, the US market for ibuprofen Tablets USP 200 mg (OTC) is approximately USD 520 Million. “The approval further strengthens company’s fast growing global OTC […]

Lopinavir syrup for children with HIV now available across India – Govt

Minister of health and family welfare Anupriya Patel said Lopinavir syrup, the life-saving drug given to infants and toddlers with HIV has been restocked by the National Aids Control Organization. “NACO has done an emergency procurement from a registered manufacturer — McNeil and Argus. The drug has already been supplied and is available throughout the […]

Govt of India starts crack down on low-quality medicine makers

The government of India has started conducting inspections at drug manufacturing units across the country to prevent the production of low-quality drugs and medicines in India. Typically, inspections are conducted by state authorities, while central agencies largely confine themselves to checking quality of final products put up on store shelves. However, in the last few […]

Cipla redraws Iran plans with new agreement, to invest Rs 121 cr

Cipla said its wholly owned subsidiary of the Company in Netherlands will set up a 75% joint venture with Ahran Tejarat Company for manufacturing and marketing of pharmaceutical products in Iran. An earlier agreement executed by the Company with the Iranian firm has been terminated. The total investment will be euro 16.875 million, which comes […]

Bliss GVS Healthcare wins three-year contract worth Rs 760 cr from Kenya

Bliss GVS Healthcare Ltd said it won a three year contract worth $111.40 mln (Rs 760 cr) from Aon Kenya Insurance Brokers Ltd for provision of medical health care services in Kenya.   Bliss GVS Pharma Ltd is a pharmaceutical company based in Mumbai, India. Bliss GVS primarily develops, manufactures and markets products across various […]

Alembic Pharmaceuticals receives FDA approval for hypertension tablets

Alembic Pharmaceuticals Ltd said it received approval from the United States Food & Drug Administration for its abbreviated new drug application for Telmisartan and Amlodipine tablets for hypertension. The Telmisartan and Amlodipine Tablets are equivalent to the Twynsta tablets of Boehringer Ingelheim Pharmaceuticals, Inc. An Abbreviated New Drug Application (ANDA) is an application for a […]

Lupin launches injectable iron formulations in India

Pharma major Lupin Limited said it launched Iron Isomaltoside injectable iron formulation under two brand names “Isofer” and “Jilazo” in India. Lupin acquired the exclusive rights to market, distribute and sell the injectable formulation from Denmark based Pharmacosmos A/S. The product is currently marketed in 33 countries, including 21 European Union countries under the brand […]

Dr Reddy’s Labs launches osteoporosis drug in the US

Dr Reddy’s Laboratories Ltd said it launched raloxifene hydrochloride tablets –used to treat osteoporosis — in the US market. Raloxifene hydrochloride tablets are a therapeutic equivalent generic version of Evista (raloxifene hydrochloride) tablets. A generic drug is a pharmaceutical drug that is equivalent to a brand-name product in dosage, strength, route of administration, quality, performance, and […]

Mylan and Biocon submits breast cancer drug application to USFDA

Mylan N.V. and Biocon Ltd. said they submitted Mylan’s biologics license application for a proposed biosimilar Trastuzumab, to the U.S. Food and Drug Administration. Biosimilar trastuzumab is a proposed biosimilar to branded Trastuzumab, which is indicated to treat certain HER2-positive breast and gastric cancers. HER2-positive breast cancer is a breast cancer that tests positive for […]

Sun Pharma to get dengue vaccine technology from ICGEB

Pharma major Sun Pharma said it tied up with research organization International Centre for Genetic Engineering and Biotechnology to develop vaccines for dengue. The vaccine is targeted against all the four serotypes of Dengue virus that cause disease in humans and is being developed to commercialize in Indian and international markets. A serotype is a […]

Aarti Industries to return Rs 96 cr to shareholders via buyback

Speciality Chemicals company Aarti Industries Ltd said it will buy back12 lakh equity shares at Rs 800 each, aggregating to Rs 96 cr. The company´s Board of Directors approved the equity shares — representing up to 1.44% of the company’s base. “The public announcement setting out the process, timelines and other requisite detail will be released […]

Marksans Pharma gets USFDA approval for synthetic Vitamin D tablets

Marksans Pharma Ltd said the United States Food & Drug Administration has given its approval for its paricalcitol capsules — a synthetic equivalent of Vitamin D. Vitamin D is important for the absorption of Calcium from the stomach and for the functioning of Calcium in the body. Paricalcitol Capsules are therapeutically equivalent to the reference […]

Fortis Healthcare to take loan of Rs 77.6 cr from Singapore bank

Fortis Healthcare said it´s Mauritius subsidiary Fortis Healthcare international Ltd, has will take a loan of SGD 165 mln (Rs 77.6 crore) from Singapore-based Consortium of Bankers. “Fortis Healthcare Ltd has being holding the company, is giving guarantee on behalf of FHIL securing the payment of principle and interest thereon.,” said the Indian company. Fortis […]

Cadila to launch immunosuppressant drug in India

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 […]

Almebic Pharmaceuticals receives inspection report from USFDA

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 receives USFDA approval for generic bone marrow drug

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 […]

FDA observations ‘primarily procedural’ –

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 […]

Lupin receives FDA approval for generic Namenda XR dementia capsules

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 […]