How to Source Clonidine HCL 100mcg Tablet for Pharmaceutical Formulation
Clonidine HCL 100mcg Tablet (Tablets, 0.1 MG, 0.025 MG) is classified under Heart Disorder. It is therapeutically aligned with reference brands such as Kapvay (USA), Dixarit (EU/UK). This guide highlights key sourcing factors buyers should consider when procuring high-quality Clonidine HCL 100mcg Tablet for formulation, R&D, or bulk manufacturing.
Product Overview:
Clonidine is a medicine used in the treatment of hypertension (high blood pressure). It lowers the blood pressure by relaxing the blood vessels. Lowering the blood pressure helps to prevent future stroke and heart attack.
Clonidine is a centrally acting alpha-2 adrenergic and imidazoline receptor agonist widely used in c...
Clonidine HCL 100mcg Tablet API – ideal for compliant pharmaceutical formulation.
Quick Insight: Over 60% of formulation delays are linked to poor API sourcing. A well-planned sourcing strategy can reduce risk and accelerate market entry.
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
Clonidine HCL 100mcg Tablet 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 Clonidine HCL 100mcg Tablet is 4–6 weeks.
- ✔ Emergency dispatch options
- ✔ Regional warehousing
- ✔ Special storage if needed
6. Formulation Support
- ✔ Technical datasheets
- ✔ Sample availability
- ✔ Stability study support
Pro Tip: Engage supplier formulation experts early — it can improve bioavailability and cut development time.
Conclusion
Sourcing Clonidine HCL 100mcg Tablet is more than procurement—it’s a strategic partnership. With its tablets form and 0.1 MG, 0.025 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 Clonidine HCL 100mcg Tablet.
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Frequently Asked Questions For Sourcing of Clonidine HCL 100mcg Tablet
What is the typical lead time for Clonidine HCL 100mcg Tablet?
Lead times range from 4–6 weeks depending on supplier and region.
Is Clonidine HCL 100mcg Tablet available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Clonidine HCL 100mcg Tablet require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Clonidine HCL 100mcg Tablet?
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 Clonidine HCL 100mcg Tablet?
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 Clonidine HCL 100mcg Tablet?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Clonidine HCL 100mcg Tablet suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Clonidine HCL 100mcg Tablet be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.
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