Alembic Pharmaceuticals Limited successfully completed a scheduled inspection by the United States Food and Drug Administration (USFDA) at its Bioequivalence Facility in Vadodara from March 3 to March 7, 2025.
Following the inspection, the USFDA issued a Form 483 with one procedural observation. Alembic Pharmaceuticals is committed to addressing the observation and will submit a comprehensive response to the USFDA within the stipulated timeframe.
In the exchange filing, the company shared, “United States Food and Drug Administration (USFDA) has conducted an inspection at our Bioequivalence Facility located at Vadodara from 3rd March, 2025 to 7th March, 2025. This was a scheduled inspection. The USFDA issued a Form 483 with one procedural observation. The Company will provide comprehensive response to USFDA for the observations within the stipulated period.”
With a strong focus on quality, compliance, and regulatory excellence, Alembic Pharmaceuticals continues to uphold the highest industry standards. The company remains dedicated to delivering safe and effective pharmaceutical products while maintaining transparency with global regulatory authorities.
In the meantime, Alembic Pharmaceuticals’ shares closed today at ₹847.00, rising from an opening of ₹810.00. The stock reached a high of ₹862.00 and a low of ₹805.00 during the trading session. Over the past year, it has fluctuated between a 52-week high of ₹1,303.90 and a low of ₹725.20.
