How to Source Midodrine hydrochloride for Pharmaceutical Formulation
Midodrine hydrochloride (Tablets, 2.5 mg, 5 mg, 10 mg) is classified under Heart Disorder. It is therapeutically aligned with reference brands such as ProAmatine (USA/EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Midodrine hydrochloride for formulation, R&D, or bulk manufacturing.
Product Overview:
Midodrine is a selective alpha‑1 adrenergic agonist that works by constricting blood vessels to increase blood pressure. It is primarily used to treat symptomatic orthostatic hypotension — a condition where blood pressure falls when a person stands up, causing dizziness and fainting. It is typically prescribed when other measures (like increased fluid/salt intake) are insufficient. Common side effects may include piloerection (“goosebumps”), scalp tingling, urinary retention, and supine hypertension.
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
Midodrine 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 Midodrine 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 Midodrine hydrochloride is more than procurement—it’s a strategic partnership. With its tablets form and 2.5 mg, 5 mg, 10 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 Midodrine hydrochloride.
Frequently Asked Questions For Sourcing of Midodrine hydrochloride
What is the typical lead time for Midodrine hydrochloride?
Lead times range from 4–6 weeks depending on supplier and region.
Is Midodrine hydrochloride available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Midodrine hydrochloride require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Midodrine hydrochloride?
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 Midodrine hydrochloride?
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 Midodrine hydrochloride?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Midodrine hydrochloride suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Midodrine hydrochloride be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.