Lambda Therapeutic Research is pleased to announce that the Abbreviated New Drug Application (ANDA) for a protein-bound paclitaxel formulation has received approval from the United States Food and Drug Administration (USFDA), supported by Lambda as the key bioanalytical partner.
This approval underscores our expertise in managing complex oncology studies and reaffirms the reliability of our bioanalytical services in advancing cancer treatment programs. Importantly, it addresses a critical shortage of paclitaxel in the United States, supporting timely patient access to an essential oncology therapy.
We remain committed to supporting high-impact programs through scientifically rigorous, quality-focused bioanalytical solutions across a broad range of therapeutic areas.
Drug Formulation: Injectable
Therapeutic Area: Oncology
Type of Application: ANDA
Study Location: India
About Lambda
Lambda & Novum delivers full-service CRO services to the innovator, biotech, and generic pharmaceutical industries worldwide. With a strong global presence in India, the USA, Canada, the UK, Spain and Poland, we bring specialized expertise to every project. Our focus on secure IT infrastructure and automation ensures timely project delivery and strict adherence to international regulatory standards. Lambda’s exemplary regulatory track record includes over 60 successful inspections and audits by esteemed authorities, including the USFDA, EMEA, MHRA, EU member states, and other global regulatory bodies, in the past five years.
Lambda’s commitment to excellence has garnered significant recognition, including the ‘Best Indian CRO’ award from Frost & Sullivan (USA) and the ‘Great Indian Workplace’ title from UBS Transformance. Recent accolades include the ‘Regulatory Excellence’ Award at the CPhI Pharma Awards 2023 and the ‘Industry Partner of the Year’ Award at the Global Generics & Biosimilar Awards 2023.
Lambda offers a wide range of bioanalytical capabilities specializing in cell-based assays, biomarkers, immunogenicity, and pharmacokinetics (PK). With state-of-the-art facilities and a team of experienced scientists, Lambda provides comprehensive solutions for the analysis of small molecules, biomarkers, biologics, and therapeutic trace elements.
