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USFDA issues EIR for Alembic Pharma Panelav facility

Vadodara: Alembic Pharma, an Indian multinational pharmaceutical company, has announced that the Company has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA) for its Oncology Formulation Facility (Injectable and Oral Solid) (F-2) at Panelav.
The inspection was held from 7th October, 2024 to 8th October, 2024.
Read also: Alembic Pharma successfully completes USFDA inspection at Panelav Oncology formulation facility
"We are pleased to inform the exchanges that the Company has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA) for the inspection carried out by them at our Oncology Formulation Facility Injectable and Oral Solid) (F-2) at Panelav from 7th October, 2024 to 8th October, 2024," the Company stated in a recent BSE filing.
The company recently also commissioned a new manufacturing facility in Madhya Pradesh for the production of formulations, representing an investment of approximately Rs 205 crore. According to the company, the rationale behind establishing the facility is to expand its business and provide an opportunity to move third-party products in-house.
Alembic already operates multiple manufacturing facilities for formulations, most of which are currently operating at optimal utilization levels.
Read also: Alembic Pharma commissions new manufacturing facility in Pithampur to expand business
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.
Alembic's brands, marketed through a field force of over 5200 are well recognized by doctors and patients.
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751