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 sales of approximately USD 119 million in the US. It is indicated for the prevention of Pneumocystis jirovecii pneuomonia (PCP) in adults and adolescents aged […]
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 of Phenytoin Sodium Extended Release capsules to be sold in the US market. Lupin’s Nagpur facility is the company’s latest site and manufactures Oral Solid Dosage […]
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 profits jumped due to a tax write-back and a jump in non-operating income. Sales at the company jumped 10.3% on quarter to Rs 516 cr […]
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 the smaller ones by sales and had 12 month sales of just around $14.0 million in the US. With this, said Glenmark, its current portfolio […]
Pharmaceutical major Cipla said it has received US FDA approval to sell a generic version of heart drug Toprol by Aralez Pharmaceuticals. Toprol and its equivalents had US sales of approximately $464 million for the 12-month period ending Aug 2018, the company said. That puts it among mid-sized drugs by sales, versus the $100 mln market size […]
Zydus Wellness, the consumer healthcare arm of Zydus Cadila, said it has agreed to acquire Heinz India Private Ltd, the Indian unit of global FMCG major Kraft Heinz. The transaction, which will be carried out in association with Cadila Healthcare Ltd, values Heinz India at Rs 4595 cr, the company said. Heinz India’s business comprises the brands Complan, Glucon D, […]
Alembic Pharmaceuticals said one of its dermatology-focused joint ventures cleared its first United States Food and Drugs Administration (USFDA) inspection at its new formulation manufacturing facility located at Karakhadi, Gujarat, India without any observations. The inspection was carried out between 15th October, 2018 and 19th October, 2018. Alembic holds 60% of Aleor, with Orbicular Pharmaceutical […]
Dr. Reddy’s Laboratories, one of the biggest pharmaceutical companies in India, said it has agreed to sell its API manufacturing unit located in Jeedimetla, Hyderabad, to Therapiva Private Ltd, an emerging generics pharmaceutical company. The company did not reveal the financial details of the deal, but said the transaction is designed as a slump sale […]
Pharmaceuticals maker Lupin said it will distribute US-based Eli Lilly and Co’s Aplevant (dulaglutide), a once-weekly injection for type 2 diabetes treatment. Lupin said it expects to make Aplevant available in India this month itself. The two companies already have a partnership dating back to 2011. With this, said Lupin, the partnership has been expanded […]
Syngene International Ltd, the contract research unit of Biocon, announced the resignation of its chief operating officer Manoj Nerurkar. It said Nerurkar, who has been with the COO of the company for nine years, will step down to an advisory role from October to pursue “an external start up opportunity outside of contract research services”. […]
Biocon, one of India’s foremost research-oriented pharmaceutical companies, said the US drug regulator has completed an inspection at its Bangalore facility without remarks. “The US FDA conducted a periodic cGMP inspection of our Drug Substance manufacturing site at Bangalore Campus from Sep 17 – 21, 2018. “The week-long audit concluded without any observations and no […]
Aurobindo Pharma said it received approval from the South African authorities to launch a key anti-HIV drug in the country, following the launch of the medicine in Sub-Saharan Africa. Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate (DLT) tablets are the first-line, preferred regimen for HIV patients as per latest WHO guidelines, the company said. “Aurobindo is […]
Pharma major Lupin said the inspection of the US Food and Drug Administration at its Nagpur plant has “concluded without any observation.” Conclusion of an inspection without any observations indicates that the facility was found to be up to the standards expected by the FDA. This inspection was a product specific pre-approval inspection, it said. […]
Sun Pharmaceutical Industries said it has got US Food and Drug Administration approval for a new eye drug that will be used for lowering intraocular pressure or IOP in patients with open-angle glaucoma or ocular hypertension. The medicine, latanoprost ophthalmic emulsion, was developed by group company Sun Pharma Advanced Research Co (SPARC), and was licensed by Sun Pharma, […]
Pharmaceuticals manufacturer Lupin said it has received US authorities’ approval to sell pneumonia medicine Atovaquone suspension. The drug had sales of approximately USD 117.4 million per year in the US. The 750 mg/5 mL oral solution is the generic version of GlaxoSmithKline’s Mepron Oral Suspension. It is indicated for prevention and acute oral treatment of […]
Zydus Cadila said it received the final approval from the USFDA to market cholesterol-lowering Gemfibrozil and antipsychotic Aripiprazole in the US. Gemfibrozil Tablets are used together with diet to treat very high cholesterol and triglyceride levels in people with pancreatitis. It is also used to lower the risk of stroke, heart attack or other heart […]
Pharma major Lupin said it has launched corticosteroid cream Clobetasol Propionate in the US. The cream is the generic equivalent of Fougera Pharmaceuticals Inc.’s Temovate. Clobetasol Propionate Cream USP 0.05% had annual sales of approximately USD 108.6 million in the US. It is used for the relief of the inflammatory and pruritic (itchy) manifestations of corticosteroid-responsive […]
India’s biggest drug maker Sun Pharmaceutical Industries reported strong numbers for the first quarter of Apr-Jun this year, with rising sales lifting margins and profits. Overall sales rose 16% on year to Rs. 7,139 crores, led by growth in key geographies such as the US, India and emerging markets. This was partly on account of […]
Alembic Pharmaceuticals said it received tentative approval from the US Food & Drug Administration for launching a therapeutic equivalent of Latisse ophthalmic solution. Allergan Bimatoprost solution is used to treat loss of hair, or hypotrichosis, of the eyelashes. The solution, with an estimated US market size of $63 million, increases the length, thickness and darkness […]
A total of 1,104 people have died during clinical trials of various drugs and procedures in India in the last three years, according to the ministry of health and family welfare. However, not everyone who died during clinical trials are found to have died from the procedure through subsequent examinations. Only the patients who are […]
