Promed Exports, a 100 per cent export-oriented Delhi-based manufacturer and second biggest player in the ophthalmic prescription market of Russia, is planning to expand its operations to the other regulated markets like United States and Europe soon.

Maintaining 30 per cent growth for the last five years on a stretch and firmly on the track to extend the stream, the company aided by its research centre in Gurgaon is planning to file 12-15 ANDAs in the next two years with a view to make a presence in the US market. ``The first ANDA is expected in the next six months,'' company president Deepak Bahri told Pharmabiz.

Promed, which has been spending around 9 per cent of its turnover on R&D over the years, has 45 new products in the pipeline, mainly the sterile generic products. It has got two international patents and has separate herbal cell under the in-house innovation facility. The company which started exports from 1990 to Russia has ophthalmic formulations, injectables, nasal drops, ear drops, wound care solutions, inhalation solutions and suspensions, most which are manufactured in its Nalagarh plant, which was commissioned last year.

"The plant is unique because of its blow-fill-seal technology. It has the annual capacity of 90 million units and we will double the capacity in the next 12-18 months. The EU inspection is due by the end of this year and US inspection would take place in the middle of next year. At present, it has the WHO certification,'' Bahri said.

After its stupendous growth in Russia, Ukraine and Kazakhstan, it is planning to enter Europe next year with generic ophthalmic solutions. It has already entered into alliance with partners in Brazil and South East Asia for exporting. However, in Russia, it has own marketing team including the field staff.

The Rs 80-crore exporter, which aims to become 100 million dollar company by 2012-13, is also planning to expand the product portfolio by entering new therapeutic areas of oncology and gastroenterology products. While keeping focus on sterile segment, it also plans to manufacture pre-filled syringes, lyophilised oncology products, injectables and sterile biotech products, he said.