Top 10 Manufacturers of Pharmaceutical Intermediate CAS No. 168828-81-7 in 2025

Understanding CAS No. 168828-81-7 – Docetaxel Intermediate

CAS No. 168828-81-7 refers to a key intermediate form of Docetaxel, often supplied as a trihydrate salt. This compound is a late-stage semi-synthetic taxane derivative prepared from 10-Deacetylbaccatin III, and it closely resembles the final active pharmaceutical ingredient (API), Docetaxel, used in chemotherapy.

This intermediate is an essential part of the taxane manufacturing pipeline, with applications in both oncology drug production and formulation R&D. Its consistent stereochemistry and high purity are critical for successful conversion into the injectable anticancer drug.

Importance of CAS No. 168828-81-7 in Oncology Manufacturing

Critical Intermediate for Docetaxel API

• CAS 168828-81-7 is the final or penultimate step in the semi-synthesis of Docetaxel, making it indispensable for API producers and CDMOs.

Used in GMP API Production

• This intermediate is manufactured under strict GMP conditions, with batch consistency and impurity control to meet ICH Q7 standards.

Facilitates Flexible Storage & Distribution

• As a trihydrate, this intermediate provides stability during storage, packaging, and transport before final conversion into Docetaxel.

Required for Scale-Up in Oncology Pipelines

• Many generic and branded producers of Docetaxel rely on this intermediate to shorten lead times and minimize process variability.

Regulatory Documentation is Crucial

• Suppliers must provide DMFs, stability data, and impurity profiles, as this intermediate often appears in regulatory filings for injectable oncology drugs.

Top 10 Manufacturers of CAS No. 168828-81-7

1. Lonza Group

• Location: Basel, Switzerland

• Overview: Lonza offers late-stage taxane intermediates like CAS 168828-81-7 under GMP for global oncology API production.

• Specialty: Final-step intermediates and high-containment manufacturing for cytotoxics.

2. Bachem AG

• Location: Bubendorf, Switzerland

• Overview: Bachem synthesizes high-purity Docetaxel intermediates, providing stereochemical precision and regulatory documentation.

• Specialty: Final-step GMP taxane intermediates with controlled hydration forms.

3. Eastfine

• Location: Changzhou City, Jiangsu Province, China

• Overview: Eastfine supplies CAS 168828-81-7 with high batch consistency, export-ready documentation, and full traceability for API manufacturers.

• Specialty: Oncology intermediates with tight impurity control and competitive cost.

4. CordenPharma

• Location: Plankstadt, Germany

• Overview: CordenPharma manufactures late-stage cytotoxic intermediates for commercial taxane production, including trihydrate forms.

• Specialty: European GMP compliance with containment capabilities for HPAIs.

5. Almac Group

• Location: Craigavon, Northern Ireland

• Overview: Almac offers GMP synthesis of Docetaxel intermediates, serving both branded pharma and generic oncology developers.

• Specialty: Final-stage custom synthesis for injectable oncology APIs.

6. Olon S.p.A.

• Location: Milan, Italy

• Overview: Olon produces key taxane intermediates like CAS 168828-81-7 in EU-inspected sites with full quality and regulatory support.

• Specialty: Scalable oncology intermediate supply across Europe and North America.

7. Carbogen Amcis

• Location: Bubendorf, Switzerland

• Overview: Carbogen Amcis handles GMP manufacturing of highly potent and late-stage oncology intermediates.

• Specialty: GMP containment for high-potency cytotoxics with DMF support.

8. Pharmaron (UK Operations)

• Location: Hoddesdon, United Kingdom

• Overview: Pharmaron UK delivers cGMP synthesis of taxane-related intermediates, including forms close to the API like 168828-81-7.

• Specialty: Fast scale-up for taxane intermediates and process optimization.

9. Aphios Corporation

• Location: Woburn, Massachusetts, USA

• Overview: Aphios specializes in supercritical fluid extraction and semi-synthesis of taxanes from 10-DAB, including intermediates like CAS 168828-81-7.

• Specialty: Natural product derivatization and clean semi-synthetic pathways.

10. Seqens Group

• Location: Ecully, France

• Overview: Seqens provides GMP production of late-stage taxane intermediates for branded and generic Docetaxel.

• Specialty: EU-based high-volume manufacturing with analytical and regulatory capabilities.

Trends in the Pharmaceutical Intermediates Market

Docetaxel Generics Fuel Intermediate Demand

With multiple approved generic versions of Docetaxel, demand for final-step intermediates like 168828-81-7 remains high globally.

Focus on Containment and Safety

Handling late-stage taxane intermediates requires containment technologies, given their cytotoxic nature and low OELs.

Growth in Injectable Oncology Drugs

With a surge in injectable oncology formulations, there’s increasing pressure for GMP-grade, injectable-quality intermediates.

API Consolidation and Strategic Partnerships

API manufacturers are partnering with trusted intermediate suppliers to lock in quality and supply chain resilience.

Regulatory Oversight and Transparency

ICH, FDA, and EMA demand comprehensive impurity profiles and validated manufacturing processes, even for intermediates.

Conclusion

CAS No. 168828-81-7 is a key intermediate in the semi-synthesis of Docetaxel, playing a crucial role in the global fight against cancer. Its use by leading manufacturers like Lonza, Bachem, and Eastfine ensures continued availability of this life-saving chemotherapy drug.

With increasing regulatory requirements and demand for oncology treatments, companies that specialize in producing this high-value intermediate under GMP conditions will remain indispensable partners in pharmaceutical manufacturing.