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

CDSCO playing a significant role in providing right medicine at the right time: Dr. Mandaviya

WuXi STA launches parenteral formulation manufacturing line at Wuxi

This is the second line opened this year for parenteral drug product clinical and commercial manufacturing, with an annual capacity of 10 million units

Casper Pharma receives EIR from USFDA for its PAI

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

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.

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

Syngene signs 10-year biologics manufacturing agreement with Zoetis

Syngene's collaboration with Zoetis started in 2011

Stelis Biopharma’s two biologics manufacturing facilities receive EU cGMP accreditation

Both manufacturing facilities are based out of Benguluru, India

Stelis Biopharma's two biologics manufacturing facilities receive EU cGMP accreditation

Stelis's small-scale cGMP manufacturing facility is designed to support smallscale commercial and cGMP clinical trial material generation

Piramal Pharma expands API capabilities at Digwal

Site has a capital investment program of ~$30 million spent or committed over the last three years to expand capabilities and improve operational efficiencies