Alembic Pharmaceuticals share price fell nearly 2 percent in the early trade on June 2 following the company received four observations from the United States Food and Drug Administration (USFDA).
At 09:29am, Alembic Pharmaceuticals was quoting at Rs 1,000.05, down Rs 17.15, or 1.69 percent, on the BSE.
It was an un-announced and routine cGMP inspection conducted by USFDA at API-I & II facility located at Panelav from May 26, 2025 to May 31, 2025.
The USFDA issued a form 483 with four observations and none of the observations are related to data integrity and management believes that they are addressable.
The company will provide comprehensive response to USFDA for the observations within the stipulated period.
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On May 30, the company received final approval from the USFDA for its abbreviated new drug application (ANDA) Bosutinib Tablets, 100 mg and 500 mg, which indicated for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy.
Also, on May 23, the company received USFDA final approval for Amlodipine and Atorvastatin Tablets USP, 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg.
The share touched a 52-week high of Rs 1,296.15 and a 52-week low of Rs 725.60 on 09 October, 2024 and 03 March, 2025, respectively.
Currently, the stock is trading 22.84 percent below its 52-week high and 37.82 percent above its 52-week low.
The market capitalisation of the company stands at Rs 19,657.30 crore.
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