New Delhi: Pharmaceutical major Dr Reddy’s Laboratories on Friday said the US health regulator has conducted a records assessment of its active pharmaceutical ingredient (API) manufacturing facility in Mexico and issued two observations.
The assessment at the facility — Industrias Químicas Falcon de México, SA de CV (Dr Reddy’s Laboratories Ltd) — has been completed by the United States Food and Drug Administration (USFDA), the company said in a regulatory filing.
The assessment was carried out between July 17 and September 8, the filing said, without sharing details of the observations made by the US health regulator.
NEW DELHI: (Sep 11) Pharmaceutical major Dr Reddy’s Laboratories on Friday said the US health regulator has conducted a records assessment of its active pharmaceutical ingredient (API) manufacturing facility in Mexico and issued two observations.
The assessment at the facility — Industrias Químicas Falcon de México, SA de CV (Dr Reddy’s Laboratories Ltd) — has been completed by the United States Food and Drug Administration (USFDA), the company said in a regulatory filing.
The assessment was carried out between July 17 and September 8, the filing said, without sharing details of the observations made by the US health regulator.
EBITDA margin contracted sharply to 12.5%, compared with 26.7% in the year-ago quarter, and remained well below the CNBC-TV18 estimate of 16.1%. The company noted that EBITDA margin was impacted by higher solvent and freight costs arising from the West Asia conflict.
Revenue from North America fell 35% year-on-year to ₹2,200 crore, though it rose 26% sequentially, accounting for 27% of consolidated revenue. The company attributed the year-on-year decline largely to lower sales of Lenalidomide.
During the quarter, Dr Reddy’s launched six new products in the region and filed five Abbreviated New Drug Applications (ANDAs) and one New Drug Application (NDA) with the US Food and Drug Administration (USFDA).
Shares of Dr Reddy’s Laboratories Ltd ended at ₹1,161.00, up by ₹20.20, or 1.77%, on the BSE.
