The US FDA has inspected the state-of-the-art formulations facility of the Chennai-based pharma major Orchid Chemicals & Pharmaceuticals Ltd. (Orchid), located at Irungattukottai, for manufacturing a range of oral and sterile cephalosporin formulation products.

The inspection covered the full spectrum of oral and sterile formulation manufacturing blocks and nine Abbreviated New Drug Applications (ANDAs) spanning the 4 dosage forms of sterile injectables, tablets, capsules and dry powder syrups, said an Orchid press release.

Orchid's Irungattukottai formulations complex has been in the forefront of Orchid's foray into regulated markets with an aggressive pace of ANDA filings. In a short span of 10 months, the facility has filed 15 ANDAs covering various dosage forms of cephalosporin antibiotics, 9 of which have been reviewed in this inspection by the USFDA. The ANDAs reviewed in the inspection include blockbuster products such as Ceftriaxone injectable and Cefprozil oral dosage forms, going off patent in July 2005 and December 2005 respectively, the release added.

Commenting on the conclusion of US FDA inspection, Orchid's managing director, K Raghavendra Rao stated that this very important milestone would take the Company onto a fast-track route to market its range of cephalosporin antibiotic products in the advanced markets of US and Europe.

Going forward, Orchid would continue to file more ANDAs in the coming months and also commission new formulation facilities at Irungattukottai for high-end betalactums as well as products of diverse therapeutic groups, already under establishment. Orchid plans to kick off its US generics market entry from July 2005, coinciding with patent expiry of Ceftriaxone and continuously expand product offerings with a judicious mix of patented products, mature generics and niche generics.

It may be recalled that Orchid has marketing alliances with leading generics companies like Apotex and Par Pharmaceutical, to distribute Orchid's sterile and oral antibiotic products in the US. Orchid anticipates a quantum jump in performance commencing from the year 2005-06, which will further be reinforced as the Company enters other regulated markets such as EU and also replicates its regulated market model in diverse therapeutic groups.