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US nod for Orchid’s drug


Our Bureau

Chennai, Sept. 16 Orchid Chemicals and Pharmaceuticals Ltd on Wednesday announced that it has received approvals from the US Food and Drug Administration for its anti-infection drug Piperacillin-Tazobactam, in injectible form.

These approvals cover Orchid’s generic equivalents in 2.25 g, 3.375 g and 4.5 g vial as well as 40.5 g (pharmacy bulk package) dosage forms and strengths.

The US FDA determined that Orchid is a ‘first applicant’ for the products and granted 180-day generic drug exclusivity. Orchid will launch these products in marketing and distribution partnership with Apotex in the US.

Related Stories:
Tazo-Pip nod: Boost for Orchid
Orchid facility gets UK approval

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