Alembic Pharma Ltd. has received an establishment inspection report from the US Food and Drug Administration for its facility in Panelav, Gujarat. The EIR was issued post the last inspection of the oral solid formulation facility conducted between July 17 and July 26, according to an exchange filing on Friday.
The FDA issues an EIR to a company when an inspection is satisfactorily closed.
Earlier in the day, the company received final approval from the FDA for its generic version of Paliperidone extended-release tablets, used to treat schizophrenia. The approved strengths are 1.5 mg, 3 mg, 6 mg, and 9 mg, and the product is therapeutically equivalent to Janssen's Invega.
Shares of Alembic Pharma closed 0.08% lower at Rs 1,194.85 apiece on the NSE, compared to a 0.14% decline in the benchmark Nifty. The share price has risen 57.38% in the last 12 months and 57.34% on a year-to-date basis.
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