Anti-Hypertension APIs
Premium Cardiovascular Active Pharmaceutical Ingredients for Blood Pressure Management
About Anti-Hypertension APIs
Holiness Pharmaceutical specializes in manufacturing and exporting high-quality Anti-Hypertension APIs for cardiovascular health management. Our comprehensive portfolio includes Angiotensin II Receptor Blockers (ARBs), Calcium Channel Blockers, ACE inhibitors, and combination therapy components manufactured under WHO-GMP standards. We serve global pharmaceutical companies in developing effective blood pressure control medications that improve patient outcomes and quality of life.
Key Features
- WHO-GMP and ISO certified cardiovascular drug manufacturing
- Compliance with IP, BP, USP, and EP pharmacopeial standards
- Multiple therapeutic classes for hypertension management
- Advanced synthesis technology for complex molecules
- Comprehensive genotoxic impurity control programs
- Polymorphic form control and characterization
- Complete regulatory support with DMF availability
- Technical guidance for fixed-dose combination development
Application Areas
Essential Hypertension
Primary treatment for high blood pressure without identified secondary causes
Cardiovascular Protection
Prevention of heart attacks, strokes, and cardiovascular complications
Diabetic Nephropathy
Kidney protection in diabetic patients with hypertension
Heart Failure Management
Reduction of cardiac workload and improvement of heart function
Combination Therapy
Multi-drug regimens for better blood pressure control
Quality Assurance
Our anti-hypertension APIs undergo comprehensive quality testing including HPLC analysis for purity and related substances, polymorphic form characterization, chiral purity assessment, genotoxic impurity screening per ICH M7, residual solvent analysis, heavy metal testing, and thorough microbiological evaluation. Each batch is certified to meet stringent international standards for cardiovascular medications.
Our Anti-Hypertension APIs Products
| Product Name | CAS Number | Grade | Form | Actions |
|---|---|---|---|---|
Amlodipine Besylate API | 88150-42-9 | IP/BP/USP | API Powder | View Product |
Losartan Potassium API | 124750-99-8 | IP/BP/USP | API Powder | View Product |
Olmesartan API | 144689-63-4 | IP/BP/USP | API Powder | View Product |
Telmisartan API | 144701-48-4 | IP/BP/EP/USP | API Powder | View Product |
Valsartan API | 137862-53-4 | IP/BP/USP | API Powder | View Product |
Frequently Asked Questions
What are Anti-Hypertension APIs?
Anti-Hypertension APIs are active pharmaceutical ingredients used to treat high blood pressure and prevent cardiovascular complications. They include various drug classes: ARBs (Angiotensin II Receptor Blockers), Calcium Channel Blockers, ACE Inhibitors, and Beta Blockers, each working through different mechanisms to lower blood pressure and protect cardiovascular health.
Which anti-hypertensive APIs does Holiness Pharmaceutical manufacture?
We manufacture Amlodipine Besylate (calcium channel blocker), Losartan Potassium (ARB), Telmisartan (ARB), Valsartan (ARB), Olmesartan (ARB), and related cardiovascular APIs. All products meet international pharmacopeial standards and are suitable for single-drug and fixed-dose combination formulations.
What is the difference between ARBs and ACE inhibitors?
Both lower blood pressure through the renin-angiotensin system. ACE inhibitors block the enzyme that produces angiotensin II, while ARBs directly block angiotensin II receptors. ARBs typically have fewer side effects like dry cough and are often prescribed when ACE inhibitors are not tolerated. Both provide cardiovascular and renal protection.
How do you control genotoxic impurities in cardiovascular APIs?
We implement comprehensive genotoxic impurity control following ICH M7 guidelines, including risk assessment during synthesis design, analytical method development for detection at ppb levels, process optimization to minimize formation, and routine testing using sensitive LC-MS techniques. All batches are certified for compliance with acceptable limits.
Can you supply APIs for fixed-dose combination products?
Yes, we supply APIs specifically for fixed-dose combinations such as Amlodipine-Valsartan, Amlodipine-Olmesartan, and Telmisartan-Amlodipine. We provide compatibility data, co-processing guidelines, and technical support for developing stable combination formulations with optimized dissolution profiles.
What polymorphic forms are controlled in your anti-hypertensive APIs?
We maintain strict polymorphic control using XRD, DSC, and FTIR characterization. For example, Amlodipine Besylate is supplied in its most stable form, while ARBs like Valsartan are controlled for specific polymorphs that ensure optimal solubility and bioavailability. Polymorphic specifications are maintained throughout shelf life.
Do you provide bioequivalence support data for generic formulations?
Yes, we provide comprehensive technical packages including comparative dissolution profiles, particle size distribution data, polymorphic characterization, impurity profiles, and stability data that support bioequivalence studies. Our regulatory team assists with ANDA filings and provides documentation required for generic drug approval.
What are the storage requirements for anti-hypertension APIs?
Most anti-hypertensive APIs should be stored in tightly closed containers protected from light and moisture at controlled room temperature (20-25°C). Specific products may have additional requirements such as refrigeration or inert atmosphere storage. Detailed storage conditions and stability data are provided with each batch's Certificate of Analysis.