Alembic Pharmaceutical has revealed that the USFDA conducted an inspection at its oncology (injectable and oral solid) formulation facility (F-2) at its Panelav centre in Gujarat.
The company has disclosed that the USFDA conducted the inspection between February 28 and March 8, 2024. After the inspection, the USFDA issued Form 483 with four procedural observations.
The Emergobyul.com defines Form 483 as a cautionary letter following an “on-site inspection if the FDA field investigator observed deficiencies in your quality system or conditions that violate the Food, Drug, or Cosmetic Act.” Usually, organisations in focus explain why the FDA field investigator’s observation is not wholly accurate. Facts and data must support the response.
The company said it is willing to provide a detailed response to USFDA for the observations within the stipulated period.
Alembic Pharmaceuticals is into developing and marketing Pharmaceuticals products.
According to The Business Standard, the company recorded a 48.01% jump in consolidated net profit to Rs 180.45 crore in Q3 FY23 compared with Rs 121.92 crore in Q3 FY22. Revenue from operations dropped 8.05% year on year (YoY) to Rs 1,630.57 crore in the quarter ended December 31, 2023. The scrip came down 0.04% to end at Rs 998.90 on March 7, 2024.
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