Orchid Chemicals & Pharmaceuticals Ltd has received the formal approval from the US FDA for its Abbreviated New Drug Application (ANDA) for its formulation product Cefazolin for Injection USP, in 500 mg/vial and 1 gm / vial strengths. This is the first ANDA approval for the Company.
The approval of USFDA for the ANDA enables the Company to launch the product in the US, Orchid informed in a release.