Orchid files ANDA for Cefazolin finished dosage form
15 May 2004
Chennai: Orchid Chemicals & Pharmaceuticals Ltd., the Chennai-based pharma major today announced that it had filed an Abbreviated New Drug Application (ANDA) for its sterile formulation product, Cefazolin. This is the first ANDA filing for Orchid that also forms part of its planned ANDA filing calendar this fiscal. Orchid's bulk Cefazolin facility in Chennai has already been inspected and approved by the USFDA in December 2003.
This ANDA has been filed from Orchid's new state-of-the-art formulations facility located in Irungattukottai, near Chennai. This facility also forms the base for Orchid's US generics business.
According to a company media release, Orchid has planned an active calendar of ANDA filings during this fiscal. The company is planning to file as many as 15 ANDAs covering all the key products that it has identified for the US Generics business, which is poised to take off from 2005. The company anticipates that it would make a strong headway into the US market based on the plans underway.
"We have been strategically focusing on the higher-margin, more profitable regulated markets and we have been accelerating our regulatory filings and offering several of our facilities and products for inspection and approval by key international regulatory agencies" said K Raghavendra Rao, managing director, Orchid Chemicals & Pharmaceuticals Ltd. "This business transformation will see stronger revenues and enhanced profitability going forward, he added"