Trabectedin is a complex marine-derived antineoplastic small-molecule API belonging to the tetrahydroisoquinoline alkaloid class. It is also known as Ecteinascidin 743 (ET-743) and is marketed as YONDELIS. Trabectedin has the molecular formula C₃₉H₄₃N₃O₁₁S, molecular weight 761.84 g/mol, and CAS Number 114899-77-3.
Trabectedin is an oncology API with activity involving DNA minor-groove binding and formation of DNA adducts. The resulting effects interfere with DNA-dependent cellular processes and DNA repair pathways. The FDA classifies trabectedin as an alkylating drug.
Trabectedin is a structurally complex, highly stereochemically defined molecule originally isolated from the Caribbean tunicate Ecteinascidia turbinata. PubChem identifies it as a tetrahydroisoquinoline alkaloid and marine metabolite.
The API is associated with oncology applications, particularly the treatment of certain soft-tissue sarcomas. Trabectedin is administered intravenously in its finished pharmaceutical formulation. FDA labeling describes YONDELIS as a sterile lyophilized white to off-white powder/cake supplied in single-dose vials containing 1 mg trabectedin.
Trabectedin is an antineoplastic API used in oncology. Its mechanism involves binding to guanine residues in the DNA minor groove and producing DNA adducts. This can alter DNA structure and interfere with transcription and DNA repair processes, contributing to cancer-cell death.
The finished pharmaceutical product YONDELIS is used for specific advanced or metastatic soft-tissue sarcoma indications under applicable regulatory labeling.
Swapnroop Drugs & Pharmaceuticals provides pharmaceutical API sourcing and supply support for Trabectedin for qualified pharmaceutical and oncology-manufacturing requirements.
As a Trabectedin API manufacturer and supplier in India, Swapnroop focuses on specification-based sourcing, product traceability, suitable pharmaceutical packaging and technical documentation. Availability, batch specifications and regulatory documentation can be provided according to customer requirements.
Trabectedin is a complex and potent oncology API and should be handled, packaged and stored according to the applicable pharmaceutical specification, safety requirements and validated stability conditions.
The finished YONDELIS product is supplied as a sterile lyophilized powder/cake in single-dose vials. FDA labeling specifies storage of the unopened product at 20°C to 25°C, with permitted excursions according to the product label.
For bulk API supply, packaging configuration and storage conditions should follow the applicable drug-substance specification and stability data.
Typical documentation available upon request may include:
Swapnroop Drugs & Pharmaceuticals supports pharmaceutical companies seeking Trabectedin API manufacturer and supplier services in India. The company focuses on specification-based API sourcing, documentation support, appropriate packaging and pharmaceutical supply requirements.
For bulk Trabectedin API requirements, customers can contact Swapnroop for availability, specifications, documentation and commercial supply information.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 20 ppm |