Norbrook Laboratories, the Newry, Co Down veterinary pharmaceutical company, has won approval from the US regulatory authority, the Food and Drug Administration (FDA), for its penicillin G procaine injectable suspension USP product.

Up to now Norbrook had to buy the raw material from a licensed producer, but now it has approval to produce the raw material itself. The company has orders for more than $15 million (£10 million) with target sales of $35 million to $40 million.

A spokesman noted that £6.5 million had been spent on research and development over the past three years. The product, Norbrook said, put it in a "unique position in the world" as it is now a primary producer of penicillin G procaine as well as being a manufacturer of the finished product.

Norbrook has also obtained clinical approval from the FDA for its formulation of the long-acting oxytetracycline injection. This product has been registered in Europe and is said to have achieved "considerable market success".

Following the two approvals, Norbrook said it now had access to a "multi-million dollar segment of the market" where it expected to be "highly competitive". They should result in the company growing to become one of the 10 top veterinary pharmaceutical companies in world, according to the group.

Norbrook employs 660 people. Formed 30 years ago, it is one of the largest producers in the world of sterile antibiotic injections for animals. It has just completed a £38 million investment programme which has taken three years to complete.

Norbrook's main manufacturing site is in Newry but it also has manufacturing facilities in Co Monaghan and in Nairobi, Kenya.

It generates around £40 million in annual sales. This is projected to grow substantially. The company has no immediate plans to go public but its founder and chairman, Dr Edward Haughey, has said: "We haven't ruled out going public after the millennium."

The company intends to expand its product line next year to include products for humans.