Bal Pharma, a mid cap pharma company based in Karnataka, is now gearing up to build up its business in the Middle East (ME) by exploring opportunities for finished formulation for the over-the-counter drugs and branded generics.

"The markets of Middle East comprise United Arab Emeritus (UAE) and Gulf Cooperation Council (GCC) nations. Though these markets are highly regulated, they offer immense opportunities for Indian pharma companies. Countries like Oman, Muscut and Qatar are now showing an increased interest for Indian pharmaceuticals that are produced under good manufacturing practices (GMP) compliance. This is where Bal Pharma is exploring the region with its herbal range too," said, Archana Dubey Mitra, associate vice president, API & Exports, Bal Pharma Ltd to Pharmabiz.

"In the UAE, we are looking to market formulations like Povidine ointment and solution under the Balvidine brand and Ocimum, a calcium supplement. We would also address the needs of Iraq market with similar products. The regulations are getting stringent in this region and as a first step the region has started demanding bio-equivalence and bio-analytical studies (BA/BE) from this year. In April 2008, the company bagged the permission to export Ashwamedh capsule in the Middle East. But the regulatory authorities required some more data for a final clearance. Although Bal Pharma has made the necessary submission, the UAE inspectorate needs to revert on this," she added.

The Middle East is dependent on imports, but the stringent regulation does not offer high market potential for pharmaceutical products. Of late, the Middle East governments have opened up local manufacturing units and this provides opportunities to Indian companies to enter the market with its range of active pharmaceutical ingredients (APIs).

Referring to Bal Pharma's API business in the region, Mitra said, "Currently, our business is focused on the formulations under OTC segment. But we also have a range of APIs like Gliclazide, Amiloride, Benzydamine, and Ebastine. The herbal product market in Middle East is also opening up and there are possibilities to get the products registered. We are exploring this opportunity."

In the Middle East, Bal Pharma is present in Jordan, Iraq, Syria, Turkey, Saudi Arabia, Yemen, Oman, Iran and UAE. The company has an office in Dubai which helps to streamline the marketing process. The company also operates through agents and distributors.