Orchid Chemicals & Pharmaceuticals Ltd. (Orchid) has received formal approval for two of its generic formulations ANDS (Abbreviated New Drug Submission), cefoxitin and ceftriaxone from the Canadian Therapeutic Product Directorate (TPD) Orchid has tied up with leading Canadian generics major, Apotex to exclusively market these products.

K Raghavendra Rao, managing director, Orchid Chemicals & Pharmaceuticals Ltd. said, "We are happy to foray into the Canadian generic segment with these approvals. With limited competition and a niche injectable product offering, we are confident of a sustainable revenue base from Canada. Given the track record of Apotex in garnering a major market share in the generic antibiotic injectable market in the US, we are optimistic that they would be able to replicate the same in the Canadian market too."

He added that going forward, Orchid would be enhancing its market presence further in Canada by launching other generic formulations in the cephalosporin and other product segments based on specific product filings and approvals.

Earlier, the company had entered into a licensing and distribution agreement with the international generic pharmaceuticals company Actavis, based in Iceland with operations in more than 30 countries. The agreement is for marketing 9 of Orchid''s cephalosporin generic formulations in Europe, comprising the entire EU (European Union) and CEE (Central & Eastern Europe) countries, numbering 37 in total

Orchid would give on non-exclusive basis marketing authorizations for all Orchids'' sterile and oral products to Actavis on a license fees basis on milestones and share revenues arising from marketing of its products. All Orchids'' products will be from the US FDA and UK MHRA approved state-of-the-art sterile and oral API and dosage form factory.

Orchid has already filed 10 dossiers with EU regulatory authorities, which include some of the products under the agreement.

Actavis, top ranking global generics major has a formidable presence in US and Europe with industry-leading capabilities in all facets of pharmaceutical operations.

Rao said "We have a successful alliance with Actavis, for development, manufacture and distribution of 10 non-cephalosporin generic products in the US. We greatly value Actavis'' decision to team up with Orchid for cephalosporin generic products in Europe. Given the vastness and heterogeneity of the European geography, the pan-European presence of Actavis and Orchid''s comprehensive product range, we are confident of achieving robust additions to our business from the European cephalosporin generics foray starting from 2007-08."