Alembic Pharma receives USFDA observations for injectable facility (F-3) at KarkhadiAPLLTD - 751 Change: 5.35 (0.72 %)
News: Alembic Pharma’s injectable facility (F-3) at Karkhadi has received a Form 483 with two observations from USFDA post its inspection from August 18, 2022 to August 30, 2022. None of the observations are related to data integrity and Alembic’s management believes they are addressable. The company is preparing the response to the observations within the stipulated period.
View: Alembic has invested ~ Rs 2500 crore in the past four years across new plants to strengthen the US pipeline and build manufacturing plants for oral solids, general and oncology injectables, dermatology and opthalmic products. Currently, Alembic Pharma’s balance sheet has capital work in progress of ~ Rs 2200 crore as facilities like F-3 (general injectable, oral soluble and onco injectable), F2 (injectable part) and F4 being new formulation facility has not been commercialised due to regulatory overhangs. When these facilities come on stream, Alembic will incur about Rs 200 crore of opex and Rs 150 crore of depreciation. Regulatory clearance and sweating of facilities earmarked for US remains key for Alembic Pharma to scale up the US base business quarterly revenues from ~ US$50 million and improve margin profile.