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Wockhardt knocks US FDA door with anti-ulcer drug application 

Anju Ghangurde  
Mumbai, March 7: Wockhardt has filed an abbreviated new drug application(ANDA), a pre-requisite for an entry into the generics market, forfamotidine tablets (an anti-ulcerant) with the US FDA. The product formspart of Wockhardt's overall joint venture arrangement with the US-basedSidmak Laboratories Inc, now an acquisition target. The joint venture withSidmak covers a series of 15 Wockhardt products to be launched in the USmarket between February 1999 and 2003.

The brand sales of the products covered under the alliance in the US is over$10.5 billion. The joint venture is based on sharing of both costs andprofits and all product labels will carry the names and logos of bothWockhardt and Sidmak. Analysts, however, say that Ranbaxy's interest(besides other international companies) in Sidmak, if it fructifies into adeal, will change the situation significantly.

The company's ANDA for enalapril tablets is currently pending with the USFDAand an approval is expected in the forthcoming quarter. Wockhardt alreadyhas ANDA approvals for niacin, captopril and ranitidine.

The company also told analysts that it has filed Drug Master Files (DMF)for azithromycin (the first to do so internationally) and famotidine bulkactives with the US FDA. This is besides the two new chemical entity (NCE)patents filed in the area of anti-infectives and three novel drug deliverysystems (NDDS) patents under review, it said.

Wockhardt's NDDS effort is expected to see the launch of four oral productsin fiscal 2000, while the company is also working on long depot preparationsof peptides and oncology drugs.

Meanwhile, the company also plans to relocate the manufacturing base forexport of its Spasgan brand to "an existing Wockhardt facility", followingthe recent approval from the Supreme Court. Wockhardt has commencedmarketing of Spasgan in Russia, currently sourced from an Indonesiancontract manufacturer and hopes to restore sales to its original levels ofRs 10 crore.

The company has also bagged a supply contract from Merck Mexico for vitaminB 12, while Eisai of Japan has approved the Indian company for the supply ofthe product.

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