At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported
WIDAPLIK is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals
With the addition of Phase II (~91 KL) in Q1 FY26, the combined capacity of the block now stands at ~200 KL
The US generic market is crucial for Indian pharma, contributing about 35% to its total revenue, around US$ 10.7 billion
AiMeD noted that proposed GST changes—to either 5% or 18%—both present significant risks requiring carefully nuanced consideration
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
Delegates also visited Emami’s WHO-GMP-certified manufacturing plant and Zandu Foundation for Healthcare farms for hands-on exposure to quality practices,
The first pillar is advanced manufacturing, focused on upgrading existing CDMO
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