How to Source Mirtazapine 30 mg Tablets for Pharmaceutical Formulation

Mirtazapine 30 mg Tablets (Tablets/ODT, 15 mg, 30 mg, 45 mg) is classified under Antipsychotropic Drugs. It is therapeutically aligned with reference brands such as US: Remeron®, Remeron SolTab®; EU: Zispin®, Mirtazapine Teva®, Mirtazon®, Espran®. This guide highlights key sourcing factors buyers should consider when procuring high-quality Mirtazapine 30 mg Tablets for formulation, R&D, or bulk manufacturing.

Product Overview: Mirtazapine is a noradrenergic and specific serotonergic antidepressant (NaSSA) that enhances norepinephrine and serotonin neurotransmission by blocking central presynaptic α2-adrenergic receptors. It is used to treat major depressive disorder (MDD), offering fast onset of action, improved sleep, and appetite stimulation. ODT formulation improves compliance in patients with swallowing difficulties. Mirtazapine Tablets and Orally Disintegrating Tablets (ODT) are FDA-approved in the USA for the trea...

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

Mirtazapine 30 mg 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 Mirtazapine 30 mg 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 Mirtazapine 30 mg Tablets is more than procurement—it’s a strategic partnership. With its tablets/odt form and 15 mg, 30 mg, 45 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.

Frequently Asked Questions For Sourcing of Mirtazapine 30 mg Tablets