Shares of Alembic Pharmaceuticals Ltd plummeted roughly 2% in early trading on 2 June after the company got four observations from the United States Food and Drug Administration (USFDA).
The USFDA conducted an unannounced and routine cGMP inspection at the API-I & II facilities in Panelav from 26 May to 31 May 2025.
The USFDA issued a form 483 with four observations, none of which are connected to data integrity, and management feels they can be addressed. The company has committed to submitting a comprehensive response to the USFDA regarding the observations within the stipulated time frame.
The company received final approval from the USFDA on 30 May for its abbreviated new drug application (ANDA) Bosutinib Tablets, 100 mg and 500 mg, indicated for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukaemia (CML) with resistance or intolerance to prior therapy.
Moreover on 23 May, the company also got final approval from the US FDA 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.
At 12:28 pm, the shares of Alembic Pharma were trading 2% lower at Rs 997.70 on NSE.
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