NEW DELHI, June 5: Drug major Lupin expects to launch up to 30 drugs in the US market in the current fiscal while it awaits approval of around 160 products from the US Food and Drug Administration (USFDA).
The Mumbai-based firm said products filings have been made to the US health regulator from company’s Indian as well as overseas facilities.
“We are looking at roughly around 25 to 30 launches, 15 out of Somerset (Gavis earlier which was acquired by Lupin) and another 15 out of India,” Lupin Group President and CEO Vinita Gupta told analysts in an investor call.
Majority of the filings out of the company’s sites in India are from Pithampur (Indore) and roughly 30 per cent from Goa, she added.
Lupin Group President and Managing Director Nilesh Gupta said: “We have about 100 filings pending approval (from India) and about 30 of them are the ones pending from Goa.”
Overall, between Lupin and Gavis together, over 160 products filings are pending for approval with the USFDA.
Lupin has a portfolio of 124 products in the US market. The company, which faced around 12 inspections from the USFDA last year, including a repeat inspection of its Goa plant, has been trying to achieve a ‘holistic transformation’ at its facilities.
“We have responded to the observations and we have provided an update…And we are now working for a holistic transformation,” Lupin Vice Chairman Kamal K Sharma said on the inspection of the Goa plant.
He further said: “We are very confident that we are going to be able to deal with it like we did it in the past in 2009.”
Preparing for any eventuality, the company has also started to move some of the pending product applications from Goa plant to other locations.
“We certainly have aligned a lot more into what we feel we need to do. (It is) hard to say at this point whether it would go into a warning letter or not, but one of the things that we are doing in terms of moving pending applications is obviously even preparing for the worst if that were to happen,” Nilesh said.
The company, however is optimistic of getting new product approvals despite challenges in Goa, Vinita Gupta said.
Hoping to resolve the issue with the USFDA, she said: “Proactively, we have started transferring the products that we expect to launch in fiscal year 2016-17 to our other approved sites to Indore, Aurangabad and to Somerset.”
On the R&D investment for the current fiscal, Nilesh said: “We believe that it will be somewhere between 12 and 15 per cent for the 2016-17 period.”
The company is also looking at a capex of over Rs 1,000 crore for the fiscal.
“The run rate in the past is close to about Rs 1,000 crore but next year we are looking at a substantially higher amount,” Lupin CFO Ramesh Swaminathan said. (PTI)
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