The Chennai-based pharma major, Orchid Chemicals & Pharmaceuticals Ltd has received approvals from US Food and Drug Administration (US FDA) for its Abbreviated New Drug Applications (ANDAs) for piperacillin and tazobactam for injection. 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 has also determined that Orchid is a 'first application' for the products and has accordingly granted 180-day generic drug exclusively, under applicable provisions. Orchid would be launching this product in marketing and distribution partnership with Apotex in the US.
Commenting on this development, K Raghavendra Rao, managing director, Orchid Chemicals & Pharmaceuticals Ltd said, "This is a great milestone in our US Generics journey. We are not only the first generic product to be approved but also have been granted technological and regulatory skills. Given the premium nature of this life-saving antibiotic and our first generic status with exclusivity, we anticipate significant contribution to our revenues and profitability from this product in the ensuing quarters."