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Aurobindo Pharma Ltd is planning to launch about 40 new products in the course of this fiscal.
The new products will be a combination of injectables, including those of Eugia, as well as certain orals, according to its Managing Director N Govindarajan. Aurobindo holds a stake in Eugia Pharma.
Aurobindo has already secured approvals for 17 abbreviated new drug applications (ANDA) from the USFDA, and these are ready for launch. In addition, 20-25 products are awaiting clearance.
In the first quarter ended June 30, Aurobindo received final approval for nine ANDAs including six injectables. It launched 15 products including four injectables besides filing 12 ANDAs including three injectable products.
As of June 2019, it had filed 551 ANDAs on a cumulative basis, said Aurobindo. Of these, 386 have final approval and 26 have tentative approvals, including nine ANDAs that are tentatively approved under the PEPFAR programme. The balance 139 ANDAs are under review.
Aurobindo said its capacity has been strengthened with the commissioning of Eugia’s manufacturing facility in the first quarter. Eugia manufactures oral and injectables in the oncology and hormonal segments.
USFDA warning
The launch of some of the products may depend on the state of affairs at Units XI, I and IX, on which Aurobindo has received warning letters from the USFDA.
The company is set to address the issues by the end of 2019, following which the US regulator will re-inspect the units.
There are about 15 products for which active pharmaceutical ingredients (API) will be sourced from all the three facilities over the next two years.
“These products include one injectable with a market size of around $25 million per IQVIA,’’ Govindarajan said in response to a query at a recent analysts’ meet.
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