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Krebs Biochemicals gets US FDA approval for Pseudoephedrine, I-Ephedrine
Our Bureau, Hyderabad | Thursday, January 1, 2004, 08:00 Hrs  [IST]

Hyderabad based Krebs Biochemicals, a 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 in Andhra Pradesh. The US FDA authorities had inspected the manufacturing facility on September 10, this year.

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 Krebs Biochemicals 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 came from these two products. The company's second unit located at Visakhapatnam produces Lovastatin, Simvastatin, Vitamin C and some other bulk actives.

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