Lupin receives EIR from USFDA for Pithampur Unit-1 Facility with VAI Classification
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection of the facility from September 16 to September 27, 2024
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection of the facility from September 16 to September 27, 2024
Increases speed to market for drug developers working on nucleic acid therapeutics
Anthem’s business comprises of CRDMO services and the manufacture and sale of Specialty Ingredients
The company will receive GMP compliance certificate which will further help to accelerate the business growth across the globe
The facility houses 33 reactors, comprising stainless steel and glass-lined varieties, with capacities ranging from 1.6 KL to 16 KL
The successful completion of RRA assessment by the USFDA, would enable company to open up its business in the USA market
The centre features a cutting-edge climatic chamber for stability testing and spectrophotometry to ensure that products meet the most stringent manufacturing and testing standards
EBITDA for the quarter is Rs. 21.6 crore as against Rs. 18.1 crore in Q2 FY24
Total Income in Q2 FY25 stood at Rs. 532.18 crore
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
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