Zydus receives EIR for the transdermal manufacturing facility

This facility underwent an inspection from 15th to 19th July 2024 and has been classified as Voluntary Action Indicated

Aurobindo Pharma receives USFDA approval for Cephalexin Tablets

The product is expected to be launched in Q3FY25

Zydus receives tentative approval from USFDA for Enzalutamide Tablets

Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad

Sun Pharma and Philogen enter into a exclusive commercialization and supply agreement for Fibromun

Sun Pharma will have the exclusive worldwide rights to commercialise Fibromun

Apitoria Pharma gets Form 483 with 10 observations from USFDA

The observations are of procedural in nature and will be responded to within the stipulated time

Morepen Laboratories appoints Amrit Ravi as Vice President

He holds a Master’s in Management from the National University of Singapore

Piramal Pharma Solutions announces US$ 80 million expansion plan for Sterile Injectables facility in Kentucky

USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia

The inspection concluded with the issuance of a form 483 with five observations

USFDA inspection update on Jubilant HollisterStier’s Montreal facility

HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures

Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma

Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations