Casper Pharma receives EIR from USFDA for its PAI

The inspection concluded with no observation (FDA-483) issued.

USFDA inspects Zydus Lifesciences Ahmedabad SEZ facility

The company will address the observations within a stipulated timeline working with the regulators

Panacea Biotec received US FDA communication for Baddi facility

The OAI classification implies that the USFDA expects further corrective actions and may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved

USFDA inspection at Alembic Pharmaceuticals Injectable Facility (F-3) at Karkhadi

Alembic Pharmaceuticals completes USFDA RRA for its bioequivalence facility

The RRA was conducted from 22nd August, 2022 to 26th August, 2022.

Glenmark receives OAI from USFDA for Goa facility

Glenmark continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest.

Glenmark receives OAI communication from US FDA

The company continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest

Sun Pharma gets OAI from USFDA for Halol facility

The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved

Briefs: Zydus Lifesciences and Kimia Biosciences

The inspection concluded with four Form 483 observations. None of the observations were related to data integrity.

Casper Pharma completed USFDA pre-approval inspection

The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.