Mumbai: Chennai-based pharmaceutical major Orchid Chemicals and Pharmaceuticals Ltd (OCPL), Thursday announced that US Food and Drug Administration (USFDA) has approved sale of its non-antibiotic, anti-emetic granisetron hydrochloride tablets in that country.
An anti-emetic is effective against vomiting and nausea. They are typically used to treat motion sickness and the side effects of certain types of analgesics, general anaesthetics and chemotherapy directed against cancer.
The company in a statement to Bombay Stock Exchange (BSE) said that USFDA has given a green signal for the company's ANDA (abbreviated new drug application) on the new generation non-antibiotic and anti-emetic granisetron (1 mg) tablets.
Following this approval, OCPL says it has become the first Indian company to get USFDA approval for a non-antibiotic drug.
According to the company's release, the approval will help OCPL garner a strong market share in the US.
• Run-up to Budget 2008-09: View Special
Earlier this year, South Africa's Medicines Control Council (MCC) had granted its approval on pharmaceutical manufacturing plants formulating cephalosporin and penicillin injectibles. That approval ensured its foray into the South African market.
At present the company has two manufacturing units in Alathur in Tamil Nadu and Aurangabad in Maharashtra.
