USFDA inspects Zydus Lifesciences Ahmedabad SEZ facility

The company will address the observations within a stipulated timeline working with the regulators

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.

Shilpa Medicare Hyderabad facility receives US FDA clearance

The facility is identified as a testing laboratory in numerous ANDAs filed by Shilpa Medicare Limited and its agreed parties

WuXi STA opens a new sterile lipid nanoparticle formulation facility

This new facility integrates multi-channel chip, micro-mixer system, and complex preparation system into a multi-channel micro-mixer core LNP manufacturing platform

Panacea Biotec received US FDA communication for Baddi facility

The OAI classification implies that the USFDA expects further corrective actions and may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved

Aurobindo Pharma to invest Rs 300 crore on mammalian cell culture manufacturing facility

The Board also decided that Auro Vaccines will explore the possibilities of offering contract manufacturing to global vaccine developers

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

Stelis Biopharma’s flagship facility receives EIR from USFDA

The integrated capabilities at Unit 2 offer significant operational flexibility, greater efficiency, and varied scope within the same premise

Alembic Pharmaceuticals completes USFDA RRA for its bioequivalence facility

The RRA was conducted from 22nd August, 2022 to 26th August, 2022.

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.