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Ranbaxy In Deeper Trouble As Apotex Seeks Declaratory Judgment On Valtrex, Aricept Exclusivity; Will Nexium and Lipitor Be Next In Line?

This article was originally published in PharmAsia News

Executive Summary

MUMBAI - U.S. FDA's punitive actions against Ranbaxy's manufacturing units in India is set to hit the company where it hurts most. Ranbaxy's 180-day exclusivity status for anti-herpes drug Valtrex (valacylovir) is in trouble as Canadian generic drug maker Apotex has sought a declaratory judgment on the drug that "will start the running of Ranbaxy's 180-day exclusivity period, even if Ranbaxy has yet to market its product.

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U.S. FDA Nails Ranbaxy On Charges Of Falsifying Data; Halts All Application Reviews From Paonta Sahib Plant

MUMBAI - India's largest drug maker Ranbaxy received a body blow after the U.S. Food and Drug Administration initiated a new regulatory action against the company's Paonta Sahib-based manufacturing plant in India. The drug regulator halted review of drug applications from the manufacturing plant due to evidence of falsified data and invoked the Application Integrity Policy

PharmAsia News Business Bulletin

A regular roundup of commercial stories appearing in Scrip’s sister publication PharmAsia News, whose multilingual team of regional experts provides authoritative business intelligence focused on the Asian marketplace. Full stories can be accessed by clicking on the story title (subscription required).

PharmAsia News Business Bulletin

A regular roundup of commercial stories appearing in Scrip’s sister publication PharmAsia News, whose multilingual team of regional experts provides authoritative business intelligence focused on the Asian marketplace. Full stories can be accessed by clicking on the story title (subscription required).

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