Generic

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EU may relax generics drug transit shipment regulations

India’s dispute with the European Union over the passage of generics drugs through EU territory is close to a resolution, or so it appears. The dispute dates back to 2008 when the EU began seizing drug shipments, of generic drugs being shipped to countries via the EU. India’s position as a leading supplier of generic drugs saw it being one of the worst affected.

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Dr Reddy’s and Fujifilm in Japanese generic tie-up

India’s Dr Reddy’s Laboratories and Japan’s Fujifilm Corporation (Fujifilm) will jointly sell generic drugs in Japan, the world’s second largest pharmaceutical market after the USA. Fujifilm is better known for its photographic products but has been added pharmaceuticals to its portfolio, as digital imaging has affected the prospects of traditional camera and film roll companies.

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Natco Pharma gets first-to-file on generic Tamiflu

Natco Pharma, an Rs 440 crore turnover pharmaceutical company, has challenged the US patent on Tamiflu held by Gilead Sciences, and licensed to F. Hoffmann-La Roche in 1996. Both Natco and Gilead announced this in separate statements. Natco said that the FDA has accepted its abbreviated new drug application (ANDA) for generic Tamiflu or oseltamivir phosphate.

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Dr Reddy’s gets to launch Allegra D-24, stock up 2.7%

Dr Reddy’s Laboratories can now launch the generic version of Allegra D-24, an extended release version of blockbuster drug Allegra. It won a key case in the US courts which will allow it to go ahead with a launch, with the possibility of a compensation being awarded by the court, but with the risk of an appeal, which could see the matter well drag on further.

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Cipla gets approval for generic pamidronate disodium

The FDA has given approval to Cipla to sell generic pamidronate disodium, a drug used to treat high blood calcium levels caused by cancer, protecting from bone problems caused by cancer and Paget’s disease of the bone. The drug was sold under the brand Aredia belonging to Novartis but is now off patent. Cipla has got approvals for the 30mg, 60mg and 90mg injection dosages of this drug. There are many generic players in the market; in early November Strides Akorn LLC (a joint venture between Akorn and Strides Arcolabs) too had got FDA approval for this drug. Continue Reading →

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