Alembic Pharmaceuticals Ltd. Secures FDA EIR for Panelav Facility Operations
Alembic Pharmaceuticals Ltd. Receives EIR from FDA for Panelav Facility
Alembic Pharmaceuticals Ltd. has recently achieved a significant milestone by obtaining an establishment inspection report from the US Food and Drug Administration (FDA) for its manufacturing facility located in Panelav, Gujarat. The EIR was granted following an evaluation that took place between July 17 and July 26, where the FDA deemed that the facility met the necessary compliance standards.
FDA Approval of Paliperidone Generic
On the same day, Alembic Pharmaceuticals also announced the receipt of final approval from the FDA for its generic version of Paliperidone, an extended-release formulation used in the treatment of schizophrenia. The approved dosages include 1.5 mg, 3 mg, 6 mg, and 9 mg, which are found to be therapeutically equivalent to Janssen's Invega.
Market Reception and Performance
Shares of Alembic Pharmaceuticals closed at Rs 1,194.85 each, reflecting a marginal decline of 0.08% on the NSE, contrasting with a slight drop of 0.14% in the benchmark Nifty index. Remarkably, the company's share price has surged by 57.38% in the past year and maintains a consistent growth of 57.34% year-to-date, showcasing the company’s resilience and focused advancements in the pharmaceutical sector.
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.