Bal Pharma, a leading Indian pharmaceutical company specialising in prescription drugs, generics, over-the-counter drugs, intravenous infusion and bulk actives, is looking to tap emerging business opportunities in Japan in the areas of active pharmaceutical ingredients (API), generics and contract manufacture of formulations.
The company entered the Japanese market three years ago with two APIs - Glicalazide, an anti-diabetic and Ebastine, an anti-histamine. Once the company consolidates its presence in Japanese market with these two APIs, it is learnt to look at increasing the product range to add Amiloride, a diuretic and Benzydamine, an anti inflammatory.
"Indian generics are in demand and we hope we will be able to penetrate into the market. Ministry of Health and Labour Welfare (MH&LW), Japan has been pressurising the local companies to opt for generics and this is where Indian pharma companies will stand to gain," said Archana Dubey Mitra, associate vice president, API & Exports, Bal Pharma Ltd.
"Japan's third largest drug maker Daiichi Sankyo Co acquired Ranbaxy and it created positive impact leading to optimism about the Indian pharma sector. Japan is looking for high quality dependable companies to import generics and APIs. Our competency in modern plant infrastructure, adherence to timelines and capability in quality generics production has shown a favourable response so far and we intend to capitalise on this acceptance," she added.
Bal Pharma is present in Japanese market through agents and once it stabilises its operations here, it is keen to open up an office and have a dedicated representative in the region. There is need for a personal interaction to ensure timelines are adhered.
"A visible trend in the region is the growing demand for anti histamine drugs and therapies for lifestyle disorders. This is where Glicalazide proved to be an important product. Since the company already had a Certificate of Suitability (COS) from Europe for marketing this anti diabetic API, making it into Japan was not a problem. In the case of Ebastine, the originator is Almirall from Spain and the company has created a good response in the market with this product," noted Mitra.
"The market size of Ebastine is $100 million. We will also look at formulation development with this API. We are also offering our contact manufacturing expertise. These job works will be carried out at the Uttaranchal facility for which technical details are being submitted to the Ministry of Health and Labour. Site Master Files are under process for MCC and UKMHRA clearance," she added.