India’s Cipla & Orchid received US FDA ok for their granisetron generics last year.
India’s Natco Pharma Ltd has received an approval from the US Food & Drug Administration to sell generic granisetron hydrochloride tablets in one milligram strength in the US market.
Granisetron is used for the prevention and treatment of acute and delayed nausea and vomiting associated with cancer chemotherapeutic drugs and radiation therapy.
The approval follows the US FDA inspection conducted at Hyderabad-based Natco Pharma’s API facility situated at Mekaguda, Andhra Pradesh in March 2008.
The USFDA inspected Natco Pharma’s facility for approval of additional products which include imatinib mesylate, anastrazole and granisetron.
The hydrochloride salt of granisetron is an indazole derivative with antiemetic properties. As a selective serotonin receptor antagonist, granisetron competitively blocks the action of serotonin at 5-hydroxytryptamine3 (5-HT3) receptors, resulting in the suppression of chemotherapy- and radiotherapy-induced nausea and vomiting
Granisetron is a potent and highly selective 5-HT3-receptor antagonist that has little or no affinity for other receptors. This characteristic makes granisetron the anti-emetic with most favorable side-effect and safety profile.
Granisetron has also been used for the prevention and treatment of post-operative nausea and vomiting.
Clinical trial data shows granisetron to be an effective and well-tolerated agent for the treatment of chemotherapy and radiotherapy induced nausea and vomiting and also that encountered in the surgical settings.
Granisetron is effective and well tolerated in special patient populations, such as those refractory to antiemetic treatment, or with hepatic or renal impairment, and even in children.
Granisetron is the original product of the Swiss drug maker Roche, which markets the drug under the brand name Kytril.
Last year, Cipla Ltd of Mumbai and Chennai-based drug manufacturer Orchid Chemicals & Pharmaceuticals got sanction from the US Food and Drug Administration (FDA) to sell their versions of generic granisetrol.
Promoted by Mr. V.C. Nannapaneni, Natco Pharma is a company engaged in manufacturing and marketing pharmaceutical substances and finished dosage forms for Indian and International markets. NATCO PHARMA began operations in 1984 in Andhra Pradesh, India.
The Hyderabad based NatcoPharma Limited had recorded consolidated revenues of Rs. 117 crores for the quarter ended on 31st December, 2008 as compared to Rs. 95 crores recorded for the same quarter last year, registering a growth of 22.5% in revenues.
Natco clocked consolidated revenues of Rs. 331 crores, as compared to Rs. 257 crores during the same period last year, registering a growth of 29%, for the nine-months period ended on 31st December, 2008.
The Profit after tax, for the quarter is higher at Rs. 12.11 crores compared to Rs. 11.43 crores during the same quarter last year, registering a growth of 6%. For the nine months period ended on 31st December, 2008, the net profit after tax has been higher at Rs. 32.71 crores, over Rs. 29.07 crores for the same period last year, recording a growth of 12.5%.
The earnings for the nine month period was Rs. 11.67 per share (compared to Rs. 10.40 per share during the last year).
Natco continues its leadership position in domestic oncology segment and has a basket of brands awaiting launch during the current year.
In April, Natco Pharma entered into an agreement with Dr Reddy’s Laboratories Ltd to jointly develop and sell generic cancer products on a profit-sharing basis. Dr Reddy’s will pay an undisclosed amount upfront for securing the rights to sell the products and for capacities to make the drugs, Natco said in a statement to the stock exchange.
The deal covers oral and injectible drugs, including paclitaxel, the generic form of Abraxis Bioscience’s breast cancer drug Abraxane.Natco will exclusively supply the drugs to Dr Reddy’s, which will sell them globally, it said. The deal could be expanded to include more products, Natco added.