Sai Life Sciences completes Phase II of production block 11 at Bidar
With the addition of Phase II (~91 KL) in Q1 FY26, the combined capacity of the block now stands at ~200 KL
With the addition of Phase II (~91 KL) in Q1 FY26, the combined capacity of the block now stands at ~200 KL
As part of its partnership with Dr. Reddy’s Laboratories (DRL), FDA acceptance also triggers a $4.2 million milestone payment to Coya
LHP588 is an oral, brain-penetrant lysine-gingipain (Kgp) inhibitor designed to block the key virulence factor of P. gingivalis
The FDA also expanded Repatha’s use as monotherapy to include patients with homozygous familial hypercholesterolemia
New manufacturing facility in Mebane to produce at least 40 million laboratory pipette tips per week
This authorization follows FDA approval in June and WHO’s July recommendation adding twice-yearly lenacapavir as a PrEP option
The US generic market is crucial for Indian pharma, contributing about 35% to its total revenue, around US$ 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
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