CDSCO and State Drugs Control Administration commence joint inspection of drug manufacturing units

A committee of two Joint Drugs Controllers has been constituted at CDSCO to monitor the process of inspection, reporting, and subsequent action to ensure compliance to the Drugs & Cosmetics Act, 1940

USFDA inspection at Alembic Pharmaceuticals’ facility at Jarod

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

USFDA completes pre-approval inspection of BHL's Vadodara facility

The pre-approval inspection of USFDA was completed successfully with ZERO 483 observation of the manufacturing facilities of Bajaj Healthcare Limited

USFDA determines inspection classification of Jubilant Pharmova's Roorkee facility

The company currently supplies one product to the US market that contributes low- single digit revenue to Jubilant Pharmova revenue

Carbogen Amcis completes Swissmedic inspection of its facility in Vionnaz, Switzerland

This inspection continues a series of successful inspections by Swissmedic in Vionnaz with the first inspection in 2015 followed by 2016, 2017 and 2020.

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.

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.

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.

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