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Hikal receives TGA approval for API export, ties up with Australian major for supply
Prabodh Chandrasekhar, Mumbai | Thursday, July 3, 2003, 08:00 Hrs  [IST]

Hikal Chemical Industries has tied up with an Australian pharma major for carrying out pharmaceutical Active Pharmaceutical Ingredients (API) exports to that country as the company has received TGA approval for its products last week. Bulk drugs like gemfibrozil, cinnarizine, pentoxyfilline, gabapentin, buzepide, flunarizane and some intermediates are likely to be exported to Australia. The company is also proficient in manufacturing acebutolol, bupropion, clocinizine dihydrochloride, nabumetone, triprolidine, and verapamil.

According to senior officials in Hikal, although the company was in talks with the Australian authorities for the past two years, it was only recently that it received written approval from the Australian agency. "Only ten days back, we received the written approval from the Australian authorities," said the company official.

Since Hikal has not yet established itself as a global player, partnering with an Australian company facilitates communication with TGA. Also, the Australian company could be a useful marketing partner for Hikal's products in Australia. "Hikal is not as well known abroad as DRL or Ranbaxy. Wherever we plan to venture abroad, we go via the tie up root where the company from the host country helps us in getting the clearance from authorities there," he said.

The company also has a similar tie-up with a US company. Although this tie up took place a year ago, the company is still awaiting an US FDA certification for its API plants. US authorities were supposed to inspect the plant in March. However on account of SARS and Gulf war, they had to stall their plans. "US FDA inspection is now slated for October 2003," said the official.

Along with the pharma sector, Hikal also does contract manufacturing for the agrochemical industry. Hikal Chemical Industries is jointly promoted by the Hiremaths and the Pune-based Kalyani group. 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.

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