This PSD-3, the first pharmaceutical spray dryer built by GEA for OEB-5 products, sets new standards for high-containment pharmaceutical spray drying
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
Merger is expected to streamline operations and provide unified management focus, driving efficiency and strategic alignment
Triggering global regulatory submissions this year for the treatment of obesity
With the addition of Phase II (~91 KL) in Q1 FY26, the combined capacity of the block now stands at ~200 KL
VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications
The new lineup includes CereTom Elite, OmniTom Elite, OmniTom Elite PCD, and BodyTom 32/64
The US generic market is crucial for Indian pharma, contributing about 35% to its total revenue, around US$ 10.7 billion
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VASOSTRICT Injection 40 Units per 100 mL and 20 Units per 100 mL of PH Health Limited
Subscribe To Our Newsletter & Stay Updated
