SENSEX 74,484.65
-417.94NIFTY 23,336.65
-141.15CRUDEOIL 9,644.00
-78.00GOLD 152,488.00
+ 147.00SILVER 233,510.00
-589.00SENSEX 74,484.65
-417.94NIFTY 23,336.65
-141.15NIFTY 23,336.65
-141.15CRUDEOIL 9,644.00
-78.00CRUDEOIL 9,644.00
-78.00GOLD 152,488.00
+ 147.00The company stated that the USFDA conducted an onsite bioequivalence inspection from August 31 to September 10, 2026
By PTI
Updated - September 11, 2026 at 02:05 PM.
| New Delhi
Alembic Pharmaceuticals on Friday said the US health regulator has completed an unannounced inspection at its bioequivalence facility in Vadodara, Gujarat, with zero observation.
In a regulatory filing, the company said the United States Food and Drug Administration (USFDA) carried out the onsite bioequivalence inspection from August 31, 2026, to September 10, 2026.
The inspection concluded with no Form 483 observations, it added.
In USFDA parlance, an FDA Form 483 is issued to a firm's management at the conclusion of an inspection when investigators observe conditions that may violate the Food, Drug, and Cosmetic Act and related regulations. No observations under this rule indicate a clean outcome.
Published on September 11, 2026
THIS AD SUPPORTS OUR JOURNALISM.
FOR MINIMAL ADS.
THIS AD SUPPORTS OUR JOURNALISM.
FOR MINIMAL ADS.
