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

USFDA completes inspection at Aurolife Pharma’s Raleigh unit

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

Cipla receives 6 observations from USFDA for Goa facility

There are no data integrity (DI) observations.

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.

US FDA Inspection at Alkem's Indore manufacturing facility

This GMP and Pre-Approval Inspection is part of the routine business operations and the company shall submit to US FDA within the stipulated timeline

Cipla updates on US FDA product-specific pre-approval inspection

The company has received 2 observations on FDA Form 483 with respect to ANDA filed for the product to be manufactured at Indore plant.

Medidata launches new clinical operations technologies to address clinical trial oversight issues

Medidata Detect and Rave CTMS Have Improved Study Execution Through Role-Based Monitoring Workflows and Clinical Data Visualization for Hundreds of Customers Across More Than 9,000 Studies

Aizon partners with TetraScience to help pharma companies speed up drug manufacturing efficiently

The partnership demonstrates increasing adoption of tetra data to create unrestricted innovation