Dr 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, 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.
One of the well known contract research and manufacturing services (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.
Advinus Therapeutics, a Tata group company, has signed a Drug Discovery Agreement with Johnson and Johnson subsidiary, Ortho-Mc-Neil-Janssen Pharmaceuticals Inc.
The company which is only into its third year has other ambitious projects to its credit like an agreement with Merck for two programs in metabolic diseases. Advinus specializes in metabolic ,inflammation and neglected diseases.