The plans of Hikal, a major contract manufacturer, to enter the lucrative US API exports market will be delayed at least by 3-4 months on account of US FDA decision to put on hold its inspection on the company's R&D and manufacturing facility in Bangalore. In an earlier statement, company's Managing Director, Jai Hiremath had said, the US FDA inspection of R&D centre and the API plant was due to happen in the first quarter of 2003.

"Incidents like SARS and Gulf war have made US FDA authorities to defer the inspection of Hikal's Bangalore facilities. We are now anticipating the inspection to take place somewhere around June-July," said a senior official at Hikal.

The company's new cGMP active active pharmaceutical ingredients plant at Bangalore is all ready for production. "Once we get the approval, we will enter the lucrative US market," said Hiremath in the statement. In fact so ready was Hikal that it had already signed a contract in September-October 2002 to supply APIs with "a large generics company" in the US. The official did not disclose the capacity of the plant and the specifics of the contract. Hikal's existing APIs plant at Bangalore is also being modernized to meet cGMP standards. The company acquired the site last year from Wintac (Bangalore).

The operation handles synthesis, process formulation and analytical development; scale-ups; and contract research, and carries out production of bulk actives as well as intermediates.

The company is also seeking opportunities in biopharmaceuticals outsourcing, and is building a facility at Pune, India. The investments are part of a plan to raise Hikal's sales fourfold, to about $ 100 million per year by 2006.

Along with the pharma sector, Hikal also does contract manufacturing for the agrochemical industry. In the meanwhile the company has already initiated API exports to Australia after receiving TGA certification from Australian drug authorities.