The USFDA inspection covered the full spectrum of oral and sterile formulation manufacturing blocks and nine Abbreviated New Drug Applications spanning the four dosage forms of sterile injectables, tablets, capsules and dry powder syrups, the Chennai-based firm informed Bombay Stock Exchange.
On the conclusion of USFDA inspection, Orchid's managing director K Raghavendra Rao said the successful inspection, without any '483' observation, signifies the company's world-class infrastructure and high-technology competency base in the finished dosage forms business established in a short span of time.
The inspection would take the company on a fast-track route to market its range of cephalosporin antibiotic products in the advanced markets of the US and Europe, he added.
The company's Irungattukottai unit manufactures a range of oral and sterile cephalosporin formulation products. It has been in the forefront of Orchid's foray into regulated markets with an aggressive pace of ANDA filings.
Within 10 months, the facility has filed 15 ANDAs covering various dosage forms of cephalosporin antibiotics, nine of which have been reviewed in this inspection by the USFDA, said Orchid's communique to BSE.
The ANDAs reviewed in the inspection include blockbuster products such as Ceftriaxone injectabte and Cefprozil oral dosage forms, going off-patent in July 2005 and December 2005 respectively, it said.