Alembic Pharmaceuticals Limited saw its shares decline by 2.6% following the conclusion of a scheduled inspection by the United States Food and Drug Administration (USFDA) at its Bioequivalence Facility in Vadodara. The inspection, which took place from March 3 to March 7, 2025, resulted in a Form 483 with one procedural observation.
The company has assured stakeholders that it remains committed to compliance and regulatory excellence. Alembic Pharma stated that it will submit a detailed response to the USFDA within the stipulated timeframe, addressing the observation in a timely and comprehensive manner.
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.”
Alembic Pharmaceuticals’ shares opened at ₹845.00, reaching a high of ₹854.75 and a low of ₹821.00. The stock remains well below its 52-week high of ₹1,303.90 but above its 52-week low of ₹725.20.
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