Drugmaker Aurobindo Pharma has started filing products from India for the Chinese market even as construction of its oral formulation manufacturing facility in the neighbouring country is underway.
“We expect to take the exhibit batches by the second half of FY-2021,” MD N. Govindarajan said during an earnings call that took place on June 4, transcripts of which were made available late last week.
He was responding to a query on the manufacturing facilities in China and if recent developments between India and China would impact the plans.
“Currently, for the Chinese market, we have already started filing products from India and the construction of our own oral formulation manufacturing facility is going on,” he said.
Besides the plant under construction, the firm has another for which it had entered into a joint venture one and a half years ago. Aurobindo is keen on supplying products under the tender route in China, where price correction is being witnessed while also looking at private business as well as overtime.
Elaborating, Mr. Govindarajan said “the regulation has changed. Preference is there for FDA-approved product and FDA-inspected facility in China. They would get preference in terms of the expedited review. The pricing in the other segments, other than tenders, is also attractive for us to move ahead. But in terms of specifics, we will have more clarity as we get closer to the filing and launch.”
Executive chairman of Aurobindo Pharma USA P. V. Ram Prasad Reddy said, “Ultimately, the China plant will be used for China’s requirements. Till that time, we may use [the facility] for China, Europe and U.S.”
To queries on the U.S. market, Mr. Govindarajan said the company had filed 55 ANDA (abbreviated new drug applications) with the USFDA during 2019-20 and is expected to file about 50-60 during the current fiscal.