Pharmaceutical manufacturer Laurus labs said it received final approval from the US Food and Drug Administration to launch a generic equivalent of Concordia Pharmaceuticals’ malaria drug Plaquenil. Hydroxychloroquine is also used for treating diseases like rheumatoid arthritis and lupus and is sold under the brand name Axemal in India. The company also received a tentative […]
Pharmaceutical major Lupin and partner Natco Pharma received approval from the US Food and Drug Administration (FDA) to sell a generic equivalent of Novartis Pharmaceuticals’ Gleevec cancer tablets in the US market. Imatinib Mesylate Tablets, in 100 and 200 mg doses, have annual sales of around $655 million in the United States, Lupin said, making […]
Glenmark Pharmaceuticals, a pharmaceutical company headquartered in Mumbai, reported progress in a proof-of-concept study of GBR 830, being studied as a treatment for atopic dermatitis, commonly known as eczema. The company said it was able to notice a decline in atopic dermatitis score during the study involving 62 patients, which also showed that the drug […]
Pharmaceuticals manufacturer Lupin said it has launched an exclusive generic version of Gilead Sciences’ heart drug Ranexa in the US. Ranolazine ER, to be sold in 500mg and 1000mg tablets, is indicated for the treatment of chronic angina or chest pain. “Products like Ranolazine bring significant savings to US consumers and are a key part […]
Strides Pharma said the US Food & Drug Administration completed an inspection of the company’s primary manufacturing facility in India with zero adverse observations. The company’s formulations facility at KRSG Gardens in Bangalore was inspected by the USFDA for good manufacturing practices in August 2018 and November 2018. Strides Pharma said it received the Establishment […]
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 notice discrepancies in the policies and practices followed in a manufacturing facility vis-a-vis the good manufacturing practices laid down by the US drug regulator. Companies […]
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 25th January said the company. All companies are supposed to observe good manufacturing practices issued by the US FDA when producing food and drugs meant […]
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 another firm. Sun Pharma stock rose 4.3% on the clarification. ADITYA MEDISALES First, Sun Pharma will move the distribution activities of its India domestic formulations […]
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 to have sales of $707 million in the US. The Indian company, which already has many of its products on US pharmacy shelves, said it […]
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 disorders which cause the inability to relax muscles following voluntary contraction. Lupin’s NaMuscla reduces myotonia symptoms in adult patients, resulting in a significant improvement in […]
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 product of Sunovion Pharmaceuticals, has sales of over $3.2 billion in the US alone, making it one of the bigger drugs in the market. Permission […]
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 mg doses, have annual sales of $601.2 million in the US, making it one of the bigger drugs in the market. Clobazam, the generic name of […]
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 $3.55 billion in the US, making it one of the biggest drugs in the market. The generic form of the drug is called Dimethyl Fumarate Delayed […]
Alembic Pharmaceuticals Ltd today announced that the company has received approval from the US Food & Drug Administration (USFDA) to sell a generic alternative to Novartis Pharmaceuticals’ allergic conjunctivitis treatment Patanol Ophthalmic Solution. This is first ophthalmic dosage form approval for Alembic pharmaceuticals Limited. The drug, olopatadine hydrochloride ophthalmic solution, has an estimated market size […]
Alembic Pharmaceuticals said it has received approval from the US Food & Drug Administration (USFDA) to sell a generic version of ANI Pharmaceuticals’ hypertension drug Atacand Tablets. Atacand had an estimated market size of US$ 22 million for twelve months ending December 2017 in the US for the three dosages for which approval has been received […]
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 the inspection, carried out in August, had been completed with one observation related to what it called a “procedural deficiency”. The receipt of an EIR is […]
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 in Japan for $1 million. Pola Pharma had annual revenues of approximately US$ 108 million and net loss of US$ 7 million for the 12 […]
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 and the company was looking forward to filing a new drug application. SPARC’s study involved Paclitaxel and Abraxane. If two products are said to be bioequivalent it […]
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, 50 mg/vial, Single-Dose Vial had annual sales of approximately USD 135.9 million in the US. The drug is the generic equivalent of Otsuka Pharmaceutical Co. Ltd.’s […]
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, with annual sales of around $475 million. It is sold by AstraZeneca under the name Pulmicort Respules Inhalation Suspension. The drug is indicated for the […]
