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

Venus Remedies secures marketing authorisations for key oncology drugs from Morocco

The authorization of bortezomib will enhance the company’s ability to deliver advanced cancer solutions in Southeast Asia

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

Dr. Reddy's invests US$ 620 million in Switzerland subsidiary

Bayer submits supplemental new drug application to USFDA seeking expanded indication for NUBEQA

NUBEQA is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC)

Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma

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

Amcor's long-term SBTi targets confirmed

The net-zero target approval complements the company's near-term emission reduction targets

Lupin signs distribution agreement with Celnova for orphan drug NaMuscla

Agreement enables access of EU-approved treatment for myotonia symptoms in non-dystrophic myotonic disorders to patients from Argentina and Colombia