How to Source Docetaxel 160 mg Injection for Pharmaceutical Formulation
Docetaxel 160 mg Injection (Injection, 20 mg/0.5 mL, 80 mg/2 mL, 160 mg/4 mL) is classified under Oncology Cancer Care. It is therapeutically aligned with reference brands such as Taxotere (US & EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Docetaxel 160 mg Injection for formulation, R&D, or bulk manufacturing.
Product Overview:
Docetaxel Injection is an oncology drug used to treat breast, lung, prostate, and gastric cancers. Offered in 20 mg, 80 mg, and 160 mg strengths, our EU-GMP and USFDA-compliant formulations are available for B2B supply, licensing, and private labeling. Suitable for distributors and hospital tenders, with alcohol-free options and full regulatory support.
Docetaxel Injection is a widely used cytotoxic chemotherapy drug indicated for breast, lung, prostat...
Docetaxel 160 mg Injection API – ideal for compliant pharmaceutical formulation.
Quick Insight: Over 60% of formulation delays are linked to poor API sourcing. A well-planned sourcing strategy can reduce risk and accelerate market entry.
1. Regulatory Compliance & Documentation
Ensure suppliers provide:
- ✔ Valid DMF (Drug Master File)
- ✔ COA (Certificate of Analysis) for each batch
- ✔ GMP, ISO, or ICH Q7 compliance certificates
2. Purity, Grade & Specification Matching
Docetaxel 160 mg Injection must meet exact grade and purity for your dosage form:
- ✔ USP / EP / JP grade verification
- ✔ Particle size distribution check
- ✔ Residual solvent and heavy metal limits
3. Supplier Reliability & Audit History
- ✔ Positive past audit reports
- ✔ Pharma client references
- ✔ Years of proven API manufacturing experience
4. Commercial Terms: Pricing, MOQ & Flexibility
- ✔ Transparent pricing
- ✔ Pilot batch MOQ flexibility
- ✔ Volume-based discounts
5. Lead Time, Inventory & Logistics
Typical lead time for Docetaxel 160 mg Injection is 4–6 weeks.
- ✔ Emergency dispatch options
- ✔ Regional warehousing
- ✔ Special storage if needed
6. Formulation Support
- ✔ Technical datasheets
- ✔ Sample availability
- ✔ Stability study support
Pro Tip: Engage supplier formulation experts early — it can improve bioavailability and cut development time.
Conclusion
Sourcing Docetaxel 160 mg Injection is more than procurement—it’s a strategic partnership. With its injection form and 20 mg/0.5 mL, 80 mg/2 mL, 160 mg/4 mL specification, choosing a compliant supplier ensures consistent quality and regulatory approval. Prioritize documentation, verify compatibility, and build relationships with transparent, reliable suppliers to secure long-term success.
Next Step: Get expert assistance in sourcing Docetaxel 160 mg Injection.
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Frequently Asked Questions For Sourcing of Docetaxel 160 mg Injection
What is the typical lead time for Docetaxel 160 mg Injection?
Lead times range from 4–6 weeks depending on supplier and region.
Is Docetaxel 160 mg Injection available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Docetaxel 160 mg Injection require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Docetaxel 160 mg Injection?
Yes, a DMF is available for regulated markets upon request. It includes detailed quality, manufacturing, and stability data.
Can I request samples or a pilot batch of Docetaxel 160 mg Injection?
Yes — pilot batches or samples can be arranged for R&D, stability studies, or formulation trials. MOQ may vary based on region and regulatory scope.
What compliance certificates are available for Docetaxel 160 mg Injection?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Docetaxel 160 mg Injection suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Docetaxel 160 mg Injection be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.
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