homevideos Newshealthcare NewsApproval for Goa facility from UK health regulator is on expected lines, says Lupin
Approval for Goa facility from UK health regulator is on expected lines, says Lupin
After UK MHRA (United Kingdom's Medicines and Healthcare products Regulatory Agency) approved Goa facility of Lupin, the company said it was on expected lines.
After UK MHRA (United Kingdom's Medicines and Healthcare products Regulatory Agency) approved Goa facility of Lupin, the company said it was on expected lines.
The unit was inspected by UK MHRA in March 2018 and there were no critical or major observations cited.
In an interview to CNBC-TV18, Ramesh Swaminathan, chief financial officer and executive director, said “It's indeed a very pleasant development. This vindicates our stand that our facilities are top-class.”
Swaminathan said the development is particularly pleasing after it comes on the heels of warning letter, which was issued by the US authorities.
“We would expect the US FDA authorities to come over and audit the facility. And this could potentially happen by the end of this calendar. So we do expect resolution happen in Q3 or Q4 of this year,” he said.
According to Swaminathan, India constitutes about 25-28 percent of Lupin's revenues and believes that country is a very key market for the company.
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