RIBOCICLIB SUCCINATE
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An overview
INHIBITOR OF CYCLIN-DEPENDENT KINASE (CDK) 4 AND 6
Treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer as initial endocrine-based therapy.
Description / use
- Product type: oncologic treatment.
- CAS number: 1374639-75-4.
- Common indications: breast cancer.
- Product status: development.
- Available grades: no micronized. Current PSD D90<200µm; adaptable to customer needs.
PROPERTIES
- Oral administration.
- Applied to the most common subtype of breast cancer.
- Potential global treatment candidates about 1.5 million people per year.
- CAGR (2023-2033) over +7.3%.
Advantages
Polymorphic Form A (US9193732B2) confirmed.
GMP Production capabilities up to 500 kg/year.
Workshop OEB 4 with engineering control measures.
Chinese manufacturer freedom to operate for this product.
Development samples and standards available with CoA.
Impurities deeply studied. Total impurities around 0.1%.
Purity > 98%.
No monograph in force. In compliance with general regulatory requirements.
Stable room temperature.
Industrial quantities available in Q3 2025.
Competitive price based on market.
Final product innovator presentations
- 200mg tablets.
- Combined targeted therapy with another hormonal drug (aromatase inhibitors and fulvestrant).
Certifications
Our API
Ribociclib succinate
- Our API ribociclib succinate is manufactured in accordance with cGMP and stringent international quality standards.
Quality
- Our quality control follows every stage from development of analytical methods to the control of manufacturing process, enabling us to achieve rigorous and stringent results in accordance with injectables parameters , even under aseptic conditions.
Samples availables
PATENT PROTECTION
