How to Source Bupropion SR/ ER Tablets for Pharmaceutical Formulation
Bupropion SR/ ER Tablets (Sustained-Release (SR) Tablets, Extended-Release (XL) Tablets, 100 mg, 150 mg, 200 mg (SR); 150 mg, 300 mg (XL)) is classified under Antipsychotropic Drugs. It is therapeutically aligned with reference brands such as Wellbutrin® SR/XL(US); Zyban®(EU & US). This guide highlights key sourcing factors buyers should consider when procuring high-quality Bupropion SR/ ER Tablets for formulation, R&D, or bulk manufacturing.
Product Overview:
Bupropion is a norepinephrine-dopamine reuptake inhibitor (NDRI) that enhances neurotransmitter activity without significantly affecting serotonin. Available in SR and ER forms, it is used to treat major depressive disorder (MDD), seasonal affective disorder (SAD), and to aid smoking cessation, with a lower risk of sexual side effects and weight gain.
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
Bupropion SR/ ER 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 Bupropion SR/ ER 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 Bupropion SR/ ER Tablets is more than procurement—it’s a strategic partnership. With its sustained-release (sr) tablets, extended-release (xl) tablets form and 100 mg, 150 mg, 200 mg (SR); 150 mg, 300 mg (XL) 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 Bupropion SR/ ER Tablets.
Frequently Asked Questions For Sourcing of Bupropion SR/ ER Tablets
What is the typical lead time for Bupropion SR/ ER Tablets?
Lead times range from 4–6 weeks depending on supplier and region.
Is Bupropion SR/ ER Tablets available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Bupropion SR/ ER 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 Bupropion SR/ ER 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 Bupropion SR/ ER 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 Bupropion SR/ ER Tablets?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Bupropion SR/ ER 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 Bupropion SR/ ER Tablets be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.