Pharma major Ind-Swift Laboratories got the Pharmaceutical and Medical Devices Agency (PMDA) approval from the Japan government for Pioglitazone and Risedronate Sodium to be manufactured at its facilities at Derabassi (Punjab). With this achievement, it has become the first Indian company to get Japanese government’s approval without any observations.
Speaking on the achievement the company’s Vice-Chairman and Managing, Director N R Munjal said, “The company has high regulatory standards where its facilities are already approved by USFDA/TGA/COS/KFDA and with this approval for Pioglitazone which is an anti-diabetic drug with market size worth $2.8 billion and Risedronate Sodium a drug for Osteoporosis with market size worth $1.6 billion, the company is aiming at capturing 15-20 per cent of the market share of these products by 2013”.
For the first time, a large number of drugs patented by Japanese companies are going off patent. With the healthcare market size of $350 billion and only $13 billion worth of pharma product imports, Japan is a promising market for the Indian Pharma manufacturers.
The rapid pace of ageing population and the high healthcare expenditures associated with it are also increasing the popularity of generics in Japan. Japan’s pharma imports from India are currently less than $10 million and these factors are likely to boost the export prospects.
“We are in the advance stage of negotiations to supply commercial quantities of these products to the Japanese market and the free trade pact between India and Japan will further strengthen the company’s export revenues,” Munjal added.
The Company has already filed four drug master files (DMFs) in Japan including that of Atorvastatin, a 12-billion market drug, PMDA approval for these products is expected shortly, which will take the total approved products to six. Ind-Swift Laboratories Limited has also filed 302 DMFs so far with various regulatory Authorites including four DMFs filed in Japan.
Company cloaked a turnover of Rs 714.32 crore during the nine months ended December 31, 2010, as against Rs 579.84 crore in the similar period in 2009. The company earned a net profit of Rs 61.22 crore in the first nine months against the net profit of Rs 57 crore earned in the financial year ended March, 2010.
