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» 2019-01-28

Indian pharmaceuticals manufacturer Dr Reddy’s Laboratories Ltd said the US FDA has issued a Form 483 after auditing its Miryalaguda plant in Telangana. A Form 483 is issued when inspectors […]

» 2019-01-26

Pharmaceutical company Lupin said that the US food and Drug administration has issued six observations after an inspection at its Pithampur manufacturing unit. The inspection was conducted between 14th and […]

» 2019-01-22

Sun Pharmaceutical Industries today announced a list of concrete steps to address investor concerns about certain relationships that it has with a couple of entities and loans allegedly extended to […]

» 2019-01-21

Indian pharmaceuticals manufacturer Wockhardt said it received approval from the United States Food & Drug Administration to launch a generic version of Novartis’ Leukemia drug Gleevec. The drug is estimated […]

» 2019-01-08

Lupin said the European Commission (EC) has approved mexiletine for the symptomatic treatment of nondystrophic myotonic (NDM) disorders in adults. Non-dystrophic myotonic disorders are a group of rare, inherited neuromuscular […]

» 2019-01-07

India-based pharmaceuticals manufacturer Lupin said it received approval from the US FDA to sell a generic equivalent of Latuda tablets for treating bipolar disorder and schizophrenia in adults. Latuda, a […]

» 2018-12-17

Pharma manufacturer Lupin said it has received approval from the US Food and Drug Administration to sell a generic equivalent of Lundbeck Pharma’s seizure drug Onfi. Onfi Tablets, in 10 and 20 […]

» 2018-12-13

Pharma major Lupin said it got approval from the US Food & Drug administration to sell a generic equivalent to Biogen’s big-selling multiple sclerosis drug Tecfidera. Tecfidera has annual sales of […]

» 2018-12-10

Alembic Pharmaceuticals Ltd today announced that the company has received approval from the US Food & Drug Administration (USFDA) to sell a generic alternative to Novartis Pharmaceuticals’ allergic conjunctivitis treatment […]

» 2018-12-05

Alembic Pharmaceuticals said it has received approval from the US Food & Drug Administration (USFDA) to sell a generic version of ANI Pharmaceuticals’ hypertension drug Atacand Tablets. Atacand had an estimated […]

» 2018-11-27

Pharma major Lupin said the US Food & Drug Administration has given it an Establishment Inspection Report for its Tarapur facility. The company had two months ago pointed out that […]

» 2018-11-26

Sun Pharmaceutical Industries said it agreed to acquire Pola Pharma Inc, a Japanese pharmaceutical company engaged in the research and development, manufacture, sale and distribution of branded and generic products […]

» 2018-11-26

Sun Pharma Advanced Research Company Ltd, the research focused unit of Sun Pharma, said a trial of its cancer formulation, Paclitaxel Injection, “met all the endpoints” of a bioequivalence study […]

» 2018-11-15

Pharmaceutical manufacturer Lupin said it received approval from the US FDA for launching Decitabine injection for treating conditions caused by defective blood cells, known as myelodysplastic syndromes. Decitabine for Injection, […]

» 2018-11-13

Indian pharmaceutical manufacturer Lupin said it received regulatory approval to launch a generic version of AstraZeneca’s asthma inhalation medicine. Budesonide Inhalation Suspension is among medium-sized drugs sold in the United States, […]

» 2018-11-13

Cipla said is US subsidiary has agreed to acquire a US company developing an intravenous formulation of the pain-relief medicine Tramadol for up to $215 million (Rs 1,500 cr). The transaction […]

» 2018-11-12

Pharma major Lupin said it has launched pneumonia suspension Atovaquone, a generic substitute for Glaxosmithkline’s Mepron oral suspension. The drug, in the dosage of 750 mg per 5 milliliter, had annual […]

» 2018-11-12

Pharma major Lupin said its Nagpur plant has passed a Pre-Approval Inspection by the US Food and Drug Administration without incident. The inspection, carried out in September, was related to the manufacture […]

» 2018-10-31

Shares of Take Solutions, a provider of contract solutions to the healthcare sector, were up 6% after the company reported a sharp increase in revenue due to rupee depreciation and […]

» 2018-10-30

Glenmark Pharmaceuticals said has got final approval from the United States Food & Drug Administration to launch generic version of Derma-Smoothe scalp oil of Hill Dermaceuticals. The drug is among […]

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