Palbociclib API Manufacturer & Supplier in India

Palbociclib is a pharmaceutical-grade active ingredient classified as a CDK4/6 Inhibitor and Antineoplastic Agent. Mediocon Inc supplies high-purity Palbociclib API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Palbociclib selectively inhibits cyclin-dependent kinases 4 and 6, blocking cancer cell cycle progression from G1 to S phase. It is primarily used in combination with hormone therapy for the treatment of HR-positive, HER2-negative advanced breast cancer.

Key Features

• High-purity pharmaceutical grade API
• IP/BP/EP/USP compliant
• Full CoA and MSDS documentation
• GMP certified manufacturing

Applications

• HR+/HER2- breast cancer
• Metastatic breast cancer (combination therapy)
• CDK4/6-driven tumors research
• Oncology formulation development

Why Choose Mediocon

• ISO 9001:2015 & GMP certified manufacturing
• Consistent batch-to-batch quality with full CoA
• Export-ready documentation: COO, MSDS, DMF
• Flexible MOQ for both R&D and commercial scale
• Dedicated QA support for regulatory filings

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Palbociclib (CAS 571190-30-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Palbociclib is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — before release with a Certificate of Analysis.

Export Markets

• USA — FDA-registered facility; DMF support available for ANDA/NDA filings
• Europe — EMA-compliant documentation; CEP/EDMF support on request
• Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
• Southeast Asia — established logistics network; temperature-controlled shipments
• India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

• ISO 9001:2015 certified quality management system
• GMP-certified manufacturing facility, Aurangabad, Maharashtra
• Full batch traceability from raw material to finished API
• Stability data available (ICH Q1A guidelines) for regulatory submissions
• Dedicated QA team for customer audits and regulatory queries