USFDA inspects Gland Pharma’s Dundigal facility

The inspection was concluded with two 483 observations

Piramal Pharma Q1 FY25 net loss narrows

EBITDA grew by 31% YoY with EBITDA margin of 11%, a YoY improvement of over 170bps vs. Q1FY24

USFDA successfully inspects Carbogen Amcis’s manufacturing sites in Neuland and Aarau

The inspections concluded with no Form 483 observations or significant critical findings

Briefs: Zydus Lifesciences and Divi's Laboratories

Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets

Rusan Pharma’s API plant in Ankleshwar receives USFDA GMP approval

Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well

Kwality Pharmaceuticals receives DIGIMED approval for generic, injectable and OSD

Kwality Pharma already has registration of 20 molecules from the units and 20 are under registration

Unichem gets 5 observations from USFDA for Goa formulation facility

The inspection closed with five observations which were more of procedural changes with none of these related to data integrity

Suven Pharmaceuticals gets Form 483 from with two observations from USFDA for Casper Pharma

The company will address these observations within the stipulated timeline

Piramal Pharma’s Ahmedabad facility completes USFDA PAI

Lupin receives EIR from USFDA for its Dabhasa facility

The facility is a part of Lupin Manufacturing Solutions