Casper Pharma receives EIR from USFDA for its PAI

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

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

US FDA issues 17 observations for Biocon Biologics sites

The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools

USFDA completes inspection at Aurolife Pharma’s Raleigh unit

The unit has filed 2 Derma products and 1 MDI product.

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.

US FDA inspection at Gland Pharma's Dundigal facility, Hyderabad

The company has received 1 (ONE) observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said Facility.

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

Briefs: Zydus Lifesciences and Kimia Biosciences

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

USFDA issues 3 observations for Aurobindo Pharma’s Unit XI

The company has responded to the warning letter and carried out the committed corrections.

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.