How to Source Desvenlafaxine Extended-Release Tablets for Pharmaceutical Formulation
Desvenlafaxine Extended-Release Tablets (Extended-Release Tablets, 25 mg, 50 mg, 100 mg) is classified under Antipsychotropic Drugs. It is therapeutically aligned with reference brands such as Pristiq®(US & EU), Khedezla®(US). This guide highlights key sourcing factors buyers should consider when procuring high-quality Desvenlafaxine Extended-Release Tablets for formulation, R&D, or bulk manufacturing.
Product Overview:
Desvenlafaxine is a serotonin-norepinephrine reuptake inhibitor (SNRI) that enhances neurotransmitter levels to help regulate mood and emotional balance. It is primarily used for the treatment of major depressive disorder (MDD) in adults. The extended-release formulation ensures once-daily dosing, providing consistent therapeutic effects with improved adherence and reduced dosing frequency.
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
Desvenlafaxine Extended-Release Tablets 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 Desvenlafaxine Extended-Release Tablets is 4–6 weeks.
- ✔ Emergency dispatch options
- ✔ Regional warehousing
- ✔ Special storage if needed
6. Formulation Support
- ✔ Technical datasheets
- ✔ Sample availability
- ✔ Stability study support
Conclusion
Sourcing Desvenlafaxine Extended-Release Tablets is more than procurement—it’s a strategic partnership. With its extended-release tablets form and 25 mg, 50 mg, 100 mg 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 Desvenlafaxine Extended-Release Tablets.
Frequently Asked Questions For Sourcing of Desvenlafaxine Extended-Release Tablets
What is the typical lead time for Desvenlafaxine Extended-Release Tablets?
Lead times range from 4–6 weeks depending on supplier and region.
Is Desvenlafaxine Extended-Release Tablets available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Desvenlafaxine Extended-Release Tablets require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Desvenlafaxine Extended-Release Tablets?
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 Desvenlafaxine Extended-Release Tablets?
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 Desvenlafaxine Extended-Release Tablets?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Desvenlafaxine Extended-Release Tablets suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Desvenlafaxine Extended-Release Tablets be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.