 "Guj pharma firms bullish on launching products in US")
The approval process at the US Food and Drug Administration (USFDA) is taking almost 30 months now, and, in turn, is expected to cause some delay in future launches planned.
However, companies like Alembic Pharmaceuticals, Intas Pharmaceuticals and Dishman Pharmaceuticals claimed that they were very much on track when it came to launching products in the US market.
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R K Baheti, director, finance of Alembic Pharmaceuticals said that "We have actually factored in the potential delay that could affect launches and have prepared our pipeline of products likewise. Therefore, the longer time that approvals are now taking would not impact the company this year. We are expecting to launch around eight products in the US during this financial year." He also informed that the company had 57 abbreviated new drug applications (ANDAs) in the pipeline, and 24 approved products in the US market, of which around 15 have already been launched.
Intas Pharma, on the other hand, expected to launch around 10-15 products in the US this year. While the company is selling 20-25 products in the US market already, it has a pipeline of nearly 100 drugs waiting for approval in the market. The future launches are likely to be in the area of chronic therapies and oncology. Besides the US, the company is also readying a pipeline for the neighbouring Mexcican market. "It is a promising market. We are already present there through a few products, and we have a good pipeline for the Mexico market as well," said a senior official in the company.
Another Ahmedabad-based ingredient and intermediates maker Dishman Pharmaceutical and Chemicals Ltd, however, claimed that for active pharmaceutical ingredients, there was hardly any delay in the approval process. J R Vyas, chairman and managing director of Dishman, said that the company is going ahead with its API plans in the US market. "Apart from the US, we are also focussing on the Japanese market," Vyas said.
Dishman is all set to launch 40 new APIs across different markets within this fiscal.
Meanwhile, the USFDA has recently hiked the fee to register an ANDA. Indian pharmaceutical firms would now have to pay close to Rs 30 lakh to register an ANDA to seek approval for selling generic drugs in the US market.
USFDA has clarified that this enactment has been done to streamline the application review and inspection process and to reduce the review time from an average 31 months to 10 months.