Pep pill

Mumbai, Sept. 14: Orchid Chemicals and Pharmaceuticals is looking at niche drugs to boost overseas sales.

The Chennai-based company sees a huge opportunity in carbapenems, which is an antibiotic and a basic ingredient for several patented products in the US and Europe.

Carbapenem-based products are injected into the body and their manufacture requires dedicated facilities.

There are only a few global companies who possess the capability to develop and manufacture carbapenem-based products, making the development of these drugs an attractive proposition for the company.

Orchid is planning to launch the products after patents on various drugs expire over the next two years.

Since very few generic firms make carbapenems, prices are likely to be high, resulting in good profit.

Orchid is also focusing on drugs that are not antibiotics. It has already made a beginning with terbinafine HCL, a generic version of Novartis’ Lamisil, which is used against fungus.

However, unlike carbapenem, the global market for non-antibiotics is very competitive, with many Indian firms in the fray. In its annual report, the company said, “Orchid has chosen products that are difficult to synthesise and manufacture as drug substance, challenging to formulate as a dosage form and which offer significant intellectual property challenges.”

The plan is to not only to develop various non-antibiotics, but also seek permission from the US authorities to market the drug. American authorities give 180-day marketing exclusivity to a drug if it fulfills certain criteria, under a system called Anda (abbreviated new drug application) with a Para IV certification.

Orchid has so far made over 50 Anda applications to market penicillin and non-antibiotics. Twenty-nine applications are for varieties of the penicillin, cephalosporin, 15 are for other penicillin variants and 16 are for non-antibiotics . Of these, the American authorities have approved 23 cephalosporins and two non-antibiotics.