How to Source Benazepril / Hydrochlorothiazide for Pharmaceutical Formulation
Benazepril / Hydrochlorothiazide (Tablets, 10 mg/12.5 mg, 20 mg/12.5 mg, 20 mg/25 mg) is classified under Heart Disorder. It is therapeutically aligned with reference brands such as Lotensin HCT (USA), Cibadrex (EU/UK). This guide highlights key sourcing factors buyers should consider when procuring high-quality Benazepril / Hydrochlorothiazide for formulation, R&D, or bulk manufacturing.
Product Overview:
Benazepril / Hydrochlorothiazide is a combination of an ACE inhibitor (benazepril) and a thiazide diuretic (hydrochlorothiazide) used to manage high blood pressure (hypertension). Benazepril helps relax blood vessels to improve blood flow, while hydrochlorothiazide increases the removal of excess salt and water from the body. This dual action effectively lowers blood pressure and reduces the risk of stroke, heart attack, and kidney problems.
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
Benazepril / Hydrochlorothiazide 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 Benazepril / Hydrochlorothiazide 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 Benazepril / Hydrochlorothiazide is more than procurement—it’s a strategic partnership. With its tablets form and 10 mg/12.5 mg, 20 mg/12.5 mg, 20 mg/25 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 Benazepril / Hydrochlorothiazide.
Frequently Asked Questions For Sourcing of Benazepril / Hydrochlorothiazide
What is the typical lead time for Benazepril / Hydrochlorothiazide?
Lead times range from 4–6 weeks depending on supplier and region.
Is Benazepril / Hydrochlorothiazide available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Benazepril / Hydrochlorothiazide require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Benazepril / Hydrochlorothiazide?
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 Benazepril / Hydrochlorothiazide?
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 Benazepril / Hydrochlorothiazide?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Benazepril / Hydrochlorothiazide suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Benazepril / Hydrochlorothiazide be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.