Pharmaceutical Sector

Aurobindo Pharma Gets USFDA Nod For Fluconazole

Drug maker, Aurobindo Pharma has informed that it has secured approval Aurobindo Pharma Gets USFDA Nod For Fluconazole from US Food and Drug Administration (USFDA) for marketing Fluconazole drug.

Under the approval, the company will market and distribute the drug in the strengths of 50 mg, 100 mg, 150 mg and 200 mg respectively. 

Fluconazole is used to treat fungal infections - yeast infections, urinary tract infections, peritonitis, pneumonia, AIDS cryptoccal infections. The drug would be available in both tablet and oral dosage form.

GSK Plans To Set Up New Manufacturing Units In Nashik, Maharashtra

World’s second major drug maker, GlaxoSmithKline (GSK) has made GSK Plans To Set Up New Manufacturing Units In Nashik, Maharashtraannouncement that the company is proposing to build a new manufacturing production line in Nashik, Maharashtra with the aim to produce 300 million tablets of albendazole per year for curing Lymphatic Filariasis (LF).

Lymphatic Filariasis (Philariasis) is a parasitic and infectious tropical disease that is caused by thread-like parasitic worms, of the type filarial nematode.

Dr Reddy gets USFDA nod for Primidone Tablets

Dr Reddy gets USFDA nod for Primidone TabletsDr Reddy's Laboratories Ltd has informed that it has received approval from the U.S. Food and Drug Administration to sell its anti-convulsant drug primidone tablets in the strength of 50 mg and 250mg in the market. 

Primidone, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.

The report stated that company is allowed to sell the drug in the United States in tablet forms of 50 milligram and 250 milligram strengths.

Strides Arcolab gets USFDA approval for manufacturing unit

Strides Arcolab gets USFDA approval for manufacturing unitStrides Arcolab, one of the leading Indian pharmaceutical company, has informed that the U.S. Food and Drug Administration (USFDA) had approved its oral dosage manufacturing unit in Bangalore.

Following this approval, Strides will be able to export drugs with regulatory approval to the United States.

Recently, the company has secured two abbreviated new drug application (ANDA) approvals for Dexamethasone injection in the strength of 4mg/ml and Dexamethasone Sodium Phosphate injection, in the strength of 10 mg /ml.

Jubilant Organosys inks JV pact with US-based Eli Lilly

Eli Lilly, Jubilant In Joint Venture

One of the well known contract research and manufacturing services Eli Lilly, Jubilant In Joint Venture(CRAMS) pharmaceutical companies in India, Jubilant Organosys has signed up a joint venture agreement with US multinational drug major firm, Eli Lilly in order to offer development services in drugs to each other.

The joint venture, which will start operationalising before the end of this year, is on similar lines as Chorus, Eli Lilly’s early-stage development division. 

Chorus provides fast drug development services to Eli Lilly by roping in external contract research specialists for specific areas of drug development.

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