How to Source Amitriptyline Hydrochloride for Pharmaceutical Formulation

Amitriptyline Hydrochloride (Tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg) is classified under Antipsychotropic Drugs. It is therapeutically aligned with reference brands such as Elavil (USA), Vanatrip (USA), Saroten (EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Amitriptyline Hydrochloride for formulation, R&D, or bulk manufacturing.

Product Overview: Amitriptyline hydrochloride is a tricyclic antidepressant widely used in the management of major dep...

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

Amitriptyline Hydrochloride 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 Amitriptyline Hydrochloride 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 Amitriptyline Hydrochloride is more than procurement—it’s a strategic partnership. With its tablets form and 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, 150 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 Amitriptyline Hydrochloride