Biotechnology firm Biocon Ltd on Friday (August 30) said it has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA) for its greenfield active pharmaceutical ingredient (API) facility, Site 6, in Visakhapatnam, Andhra Pradesh.
“This is to inform you that the Company has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (US FDA), for our greenfield API facility (Site 6), located at Visakhapatnam, Andhra Pradesh,” Biocon said in a stock exchange filing.
The EIR follows a pre-approval inspection conducted by the agency from June 10-14, 2024. With this approval, Biocon is authorised to begin commercial supplies from this facility to the US market.
What is an EIR? An Establishment Inspection Report is a document which is issued with a lag after a plant inspection has taken place by the US FDA. Issuance of an EIR does not mean the plant is cleared.
Also Read: CNBC-TV18 accesses USFDA observations for Biocon Biologics unit. Details here
“This is based on a pre-approval inspection conducted by the agency between the 10th and 14th of June, 2024, and now allows us to commence commercial supplies from this facility to the US market,” the company said.
Biocon reported a 550.59% year-on-year (YoY) jump in net profit at ₹659.7 crore for the first quarter that ended June 30, 2024. In the corresponding quarter, Biocon posted a net profit of ₹101.4 crore, the company said in a regulatory filing. The CNBC-TV18 poll had predicted a profit of ₹151.2 crore for the quarter under review.
The company’s revenue from operations increased 0.3% to ₹3,432.9 crore against ₹3,422.6 crore in the corresponding period of the preceding fiscal. The CNBC-TV18 poll had predicted revenue of ₹3,922.5 crore for the quarter under review.
Also Read: Biocon Biologics exploring multiple strategies to reduce debt, says MD Shreehas Tambe
At the operating level, EBITDA dropped 13.2% to ₹620.4 crore in the first quarter of this fiscal over ₹714.4 crore year-on-year. The CNBC-TV18 poll had predicted an EBITDA of ₹853.2 crore for the quarter under review.
Shares of Biocon Ltd ended at ₹359.30, up by ₹4.05, or 1.14%, on the BSE.
(Edited by : Shoma Bhattacharjee)
