Also known as: Trastuzumab / Herceptin
Trastuzumab (Herceptin) is a recombinant humanized monoclonal antibody targeting the HER2/neu receptor. It is used in the treatment of HER2-positive breast cancer and gastric cancer. Mediocon Inc supplies pharmaceutical-grade Trastuzumab API with full batch documentation.
Key Features
Applications
Why Choose Mediocon
| Parameter | Specification |
|---|---|
| Assay | ≥95.0% (by SDS-PAGE) |
| Loss on Drying | NMT 5.0% |
| Heavy Metals | NMT 20 ppm |
| pH | 6.0 – 7.0 (reconstituted) |
| Microbial Limits | Complies with pharmacopoeia |
| Identification | IR, HPLC Compliant |
| Packing | 25 kg HDPE drums / as per requirement |
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Herceptin (Trastuzumab) (CAS 180288-69-1) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Herceptin (Trastuzumab) 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
Quality & Compliance