Alembic Pharmaceuticals said it received approval from the US Food & Drug Administration for selling a generic equivalent of AstraZeneca’s heart drug Atacand. Approval was granted for the sale of candesantan cilexetil in the dosage of 32 mg. Candesartan cilexetil is used for treatment of hypertension in adults and children and treatment of heart failure. […]
Glenmark Pharmaceuticals said it entered into a licensing agreement with Boston-based biopharmaceutical company APC Therapeutics Inc for exclusive rights for a cancer drug. The agreement covers a small molecule based on Antigen Presenting Cell (APC) biology, the Indian company said. “The compound has the potential to be used as a monotherapy or in combination with […]
Zydus Cadila said it received final approval from the US Food and Drug Administration to market migraine drug Eletriptan Hydrobromide in the US. The drug is currently marketed and manufactured by Pfizer Inc and sold in the US and Canada under the brand name Relpax. The two key patents covering the drug are listed as […]
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 […]
Aurobindo Pharma said it received final approval from the US Food & Drug Administration to manufacture generic version of kidney drug Renvela from Genzyme. Sevelamer Carbonate oral suspension, 0.8 gm and 2.4 gm is being launched immediately, the company said. The drug had a market size of US$140 million (Rs 900 cr) for the twelve […]
Pharma Major Lupin said received final approval for launching a generic version of Mallinckrodt Inc.’s Roxicodone Tablets in the United States. The drug is used for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, the company said. Roxicodone Tablets has US sales of USD 344 […]
Suven Life Sciences Ltd said it got a patent from Australia and another from the US for a new molecule used for treating disorders associated with Neurodegenerative diseases. The ‘new chemical entity’ patent no 2014358652 from Australia is valid through 2032, while that from the US will last till 2034, the company said. The chemical […]
Generic drug manufacturer Unichem Laboratories said its formulations manufacturing facility at Ghaziabad has successfully exited an inspection by the US Food and Drug Administration. It received an Establishment Inspection Report (EIR) from the USFDA, the company said. “This receipt indicates the successful closure of the inspection and the queries raised during the audit (Form 483). […]
Zydus Cadila said the US Food and Drug Administration has given the final approval to market the company’s Mesalamine Delayed-Release Tablets in the US market. Zydus Cadila was the first to file an Abbreviated New Drug Application (ANDA) for a generic version of Lialda. Lialda is indicated for the treatment of mild to moderate ulcerative […]
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 […]
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 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 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 […]
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 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 […]
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 […]
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 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 […]
India may have emerged as a key supplier of generic and affordable medicine for the world market, but it has an “overwhelming dependence” on China for the raw material required to produce these drugs, industry association Assocham said. Indian companies depend on China to supply them with the main raw material in drug making — […]
Pharma Major Lupin Ltd. said its US subsidiary, Lupin Pharmaceutical Inc., has agreed to license technology from Monosol Rx to develop multiple paediatric-focused products. Lupin would develop the pediatric products utilizing MonoSol Rx’s proprietary PharmFilm drug delivery technology. MonoSol Rx’s PharmFilm technology is a drug delivery platform that provides precision dosing in the form of […]
