Biocon Ltd announced on Friday, August 30, that it has obtained an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (US FDA) for its new active pharmaceutical ingredient (API) manufacturing facility, known as Site 6, in Visakhapatnam, Andhra Pradesh.
“The Company has received an Establishment Inspection Report (EIR) from the US FDA for our greenfield API facility (Site 6) in Visakhapatnam, Andhra Pradesh,” Biocon stated in a filing with the stock exchange. This EIR comes after a pre-approval inspection conducted by the US FDA from June 10 to 14, 2024. The approval enables Biocon to begin commercial shipments from this facility to the United States.
An EIR, or Establishment Inspection Report, is a document issued after a US FDA inspection of a manufacturing plant. Receiving an EIR does not necessarily mean the facility is fully cleared by the FDA. “This approval follows a pre-approval inspection conducted by the US FDA between June 10 and 14, 2024, allowing us to start commercial supplies to the US market,” Biocon added.
In the first quarter ending June 30, 2024, Biocon reported a significant year-on-year (YoY) increase in net profit, reaching ₹659.7 crore, up by 550.59% from ₹101.4 crore in the same period last year, according to a regulatory filing.
The company’s revenue from operations rose slightly by 0.3% to ₹3,432.9 crore, compared to ₹3,422.6 crore in the same quarter of the previous fiscal year. CNBC-TV18 had estimated revenue at ₹3,922.5 crore for the quarter under review.
However, at the operating level, Biocon’s EBITDA declined by 13.2%, amounting to ₹620.4 crore in the first quarter of the current fiscal year, down from ₹714.4 crore YoY. CNBC-TV18 had projected an EBITDA of ₹853.2 crore for this quarter.
