Drug Approval | May 03, 2025
USFDA inspection at Concord Biotech’s API facility at Dholka
These observations are procedural in nature and none of them are related to data integrity
These observations are procedural in nature and none of them are related to data integrity
The FDA issued Form 483 with one observation related to building and facility management
Niacin is indicated to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides (TG)
This partnership marks a significant milestone in Sigachi's strategy to expand into advanced drug delivery technologies.
The Subsidiary has received one inspectional observation in Form 483
Celecoxib Capsules approval complements Strides’ existing products to serve a broader patient base
This Product is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension
The foray into this new segment will help Vimta to enter into the growing CDMO business of biologics and peptides
The inspection concluded with 6 observations and none of them were related to Data Integrity
Investment demonstrates confidence in America’s commitment to science and innovation
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