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Krebs gets FDA nod for 2 drugs

Our Regional Bureau  |  Hyderabad 

Ltd, the city-based Rs 120-crore bulk actives manufacturer, has received the US Food and Drug Administration's approval for Pseudoephedrine and I-Ephedrine products manufactured at its Nellore unit.
The US FDA authorities inspected the manufacturing facility in September this year.
Though the company has been exporting these products to the US market for the last several years, they are going to into over the counter drugs for all these years.
The US FDA approval will enable the company to supply these products for use in drugs meant for prescription market in US, and is expected to yield at least 10-15 per cent higher price than what it has been getting at present.
Pseudoephedrine/ I-Ephedrine will go as one of the bulk active ingredients in bronchodilator and decongestant drugs.
The Nellore unit of has a capacity to produce about 300 tonnes of Pseudoephedrine/ I-Ephedrine per annum.
Of the Rs 60 crore sales that the company recorded in the first-half of the current fiscal, about Rs 35 crore had come from these two products.
The company's second unit located at Visakhapatnam produce Lovastatin, Simvastatin, Vitamin C and some other bulk actives.

First Published: Thu, January 30 2003. 00:00 IST
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