Alembic Pharmaceuticals Ltd. Receives FDA EIR for Panelav Facility
Alembic Pharmaceuticals Ltd. Receives FDA EIR
Alembic Pharmaceuticals Ltd. has successfully received an establishment inspection report (EIR) from the US Food and Drug Administration (FDA) for its Panelav facility located in Gujarat. The EIR was issued after a recent inspection of the oral solid formulation facility that took place from July 17 to July 26. This approval is a positive signal as the FDA now considers the inspection satisfactorily closed.
Approval for Generic Paliperidone Tablets
In a remarkable twist, Alembic Pharma also announced that it has obtained final approval from the FDA for its generic version of Paliperidone extended-release tablets, essential for treating schizophrenia. The approved strengths include 1.5 mg, 3 mg, 6 mg, and 9 mg, rendering it therapeutically equivalent to Janssen's Invega.
Market Impact and Performance
Following these announcements, shares of Alembic Pharma experienced a slight dip of 0.08%, closing at Rs 1,194.85 apiece on the NSE, amid a broader market decline of 0.14% in the benchmark Nifty. Notably, the share price has seen an impressive growth of 57.38% over the past year and a similar rise of 57.34% year-to-date.
This article was prepared using information from open sources in accordance with the principles of Ethical Policy. The editorial team is not responsible for absolute accuracy, as it relies on data from the sources referenced.