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Ranbaxy gets US FDA nod for sumatriptan tabs



4 August, 2005: Ranbaxy Pharmaceuticals Inc. (RPI) has received tentative approval from the US Food and Drug Administration to manufacture and market sumatriptan succinate tablets in 25 mg, 50 mg and 100 mg strengths.

As per IMS (MAT: March 2005) figures total annual market sales for sumatriptan succinate tablets were $857 million (+2.8%). Ranbaxy’s sumatriptan succinate tablets is the generic equivalent of GlaxoSmithKline’s Imitrex. The drugs is indicated for the acute treatment of migraine attacks with or without aura in adults. 

Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, USA, is a wholly owned subsidiary of the New Delhi-based Ranbaxy Laboratories. RPI is engaged in the sale and distribution of generic and branded prescription products in the US.

Ranbaxy Laboratories Limited, India's largest pharmaceutical company, manufactures and markets brand and generic pharmaceuticals and Active Pharmaceutical Ingredients. Ranbaxy has won several approvals in developed markets. Ranbaxy's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies" resulting in a number of products under development. The company is selling its products in over 100 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 44 countries and manufacturing operations in 7 countries.

Ranbaxy's USA operations achieved sales of USD 82 million (Q2 2004: USD 92 mn), for the second quarter of the year 2005 . For H1, USA recorded sales of USD 162 million (2004 : USD 197 mn).

During the quarter, Ranbaxy's US operations achieved a significant milestone with the company gaining its 100 th ANDA approval from the US Food and Drug Administration, for its metformin hydrochloride extended-release tablets, 750 mg. The cumulative product filings in the US now stand at 152, of which 50 are pending approval with the US FDA. For H1 2005, the company filed 6 ANDAs with the US FDA and received approval for 6.

Ranbaxy's total prescription (TRx) growth in the US market recorded a healthy increase of 26% in Q2, 2005, compared to the industry growth of 16%, improving the company's ranking by two positions to 12 th on this important parameter.

Ranbaxy’s US product pipeline is valued at over USD 30 billion (at innovator market size) including 11 First-to-File (FTF) products which alone command a market size of around USD 14 billion. These FTF products are expected to be launched during the period 2005-06 to 2013-14, subject to the requisite legal and regulatory approvals.

Ranbaxy also became the first Indian company to receive USFDA approval for an anti-retroviral (ARV) drug under the US President's Emergency Plan for AIDS relief (PEPFAR) program. The company has since gained a total of 3 tentative ARV approvals and has made 8 filings under the PEPFAR initiative.

Ranbaxy Pharmaceuticals Inc. (RPI), received the prestigious Supplier Award from Wal-Mart, the largest chain store in the USA, for outstanding performance in the first quarter of 2005, says an official release.


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