Nectar Lifesciences receives 7 observations from EDQM for API facility
The European regulator will conduct a re-inspection of the facility to verify the compliance
The European regulator will conduct a re-inspection of the facility to verify the compliance
The MDR certification reafirms that these products meet the highest safety, quality, and regulatory standards
Will add UNLOXCYT (cosibelimab-ipdl), the first and only FDA-approved anti-PD-L1 treatment for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) to Sun Pharma's global onco-derm franchise
The study demonstrated equivalent efficacy, safety, immunogenicity, and pharmacokinetics between YESINTEK and the reference product Stelara
USFDA inspection at Alembic Pharma's Bioequivalence facility
Zydus will carry out early-stage development, animal immunogenicity studies and regulatory preclinical toxicology studies for this combination vaccine
The launch follows the approval from the Medicines and Healthcare Products Regulatory Agency (MHRA), U.K.
The acquisition aligns with Granules' vision to enter the rapidly expanding peptide-based anti-diabetic and anti-obesity market
We will continue to expand our range of purified excipients, offering pharmaceutical companies a dependable partner
The Alathur facility specializes in the production of Cephalosporin antibiotics
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