USFDA Issues a CRL for the Biologics License Application for Insulin Aspart

The CRL did not identify any outstanding scientific issues with the product.

USFDA visit to Alembic Pharmaceuticals Panelav facility

None of the observations are related to data integrity and Alembic Pharmaceuticals management believes that they are addressable

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.

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.

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.

Dr. Reddy's Laboratories updates on PAI of formulations facility

The company has been issued a Form 483 with two observations which the company will address within the stipulated timeline.