How to Source Demeclocycline hydrochloride for Pharmaceutical Formulation

Demeclocycline hydrochloride (Tablets, 150mg, 300mg) is classified under Antibiotics. It is therapeutically aligned with reference brands such as Declomycin (USA/EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Demeclocycline hydrochloride for formulation, R&D, or bulk manufacturing.

Product Overview: Demeclocycline is a semisynthetic tetracycline antibiotic used to treat a variety of bacterial infections including respiratory, urinary, skin, eye, and tick-borne illnesses. It also has a unique “off-label” role in treating the syndrome of inappropriate antidiuretic hormone secretion (SIADH) by reducing renal sensitivity to ADH, thereby promoting water excretion. It must be taken on an empty stomach (at least 1 hour before or 2 hours after meals, especially avoiding dairy products) due to absorption issues. Common adverse effects include photosensitivity, tooth discoloration in children, and potential for nephrogenic diabetes insipidus when used in high doses.

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

Demeclocycline 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 Demeclocycline 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 Demeclocycline hydrochloride is more than procurement—it’s a strategic partnership. With its tablets form and 150mg, 300mg 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 Demeclocycline hydrochloride