Company Watch

Orchid receives two US FDA approvals

Deepalakshmi K - Chennai

Chennai-based pharma major, Orchid Chemicals and Pharmaceuticals announced that it has received approval from the US FDA for its Abbreviated New Drug Application (ANDA) for granisetron hydrochloride tablets. "We are the first company to be approved for this non-antibiotic product," claims Ch Ram, Head-Corporate Communication and Investor Relations, Orchid. Granisetron is a new generation non-antibiotic product. This anti-emetic oral drug product is available in 1-mg dosage strength. Granisetron can be used to treat nausea and vomiting caused be radiotherapy, chemotherapy and surgery. Granisetron hydrochloride was originally formulated by Roche Pharmaceuticals, USA. It is sold in the brand name Kytril as injection, tablets and oral solution.

"Including Orchid, there are about six players in India engaged in this generic formulation," explained Ram. Being a niche product, with limited generic competition, Orchid anticipates acquiring a minimum of five to ten percent market share soon after the launch. Orchid is hopeful of leading to a sizeable revenue contribution from this product. Orchid is planning to hold a formal launch of the product, where the brand name and the price is expected to be revealed. "While sale of the drug is intended for US market now, we have plans to launch the product in India in the future," said Ram. Apart from granisetron hydrochloride tablets, Orchid also got approval for its Abbreviated New Drug Application (ANDA) cefuroxime axetil tablets. The product is available in three dosage strengths, 125 mg, 250 mg and 500 mg. This is the 25th ANDA approval that Orchid has received since it started in the US market in 2005.

k.deepalakshmi@expressindia.com