Cardiovascular APIs
Premium Heart Health Active Pharmaceutical Ingredients for Cardiovascular Disease Management
About Cardiovascular APIs
Holiness Pharmaceutical specializes in manufacturing and exporting high-quality Cardiovascular APIs for managing heart disease and related conditions. Our portfolio includes statins, antihypertensives, and other cardiovascular agents manufactured under WHO-GMP standards. We serve pharmaceutical companies globally, supporting the development of life-saving medications that reduce cardiovascular mortality and improve patient 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 comprehensive cardiac care
- Advanced chiral synthesis for enantiomerically pure drugs
- Comprehensive genotoxic impurity control programs
- Polymorphic form control and characterization
- Complete regulatory documentation and DMF support
- Technical guidance for fixed-dose combination development
Application Areas
Coronary Artery Disease
Prevention and management of heart attacks and angina
Heart Failure
Treatment to improve cardiac function and reduce hospitalizations
Arrhythmias
Management of abnormal heart rhythms and atrial fibrillation
Stroke Prevention
Reduction of stroke risk through anticoagulation and risk factor control
Atherosclerosis Prevention
Lipid management to prevent plaque formation and cardiovascular events
Quality Assurance
Our cardiovascular APIs undergo comprehensive quality testing including HPLC analysis for purity and chiral purity, polymorphic form characterization using XRD and DSC, genotoxic impurity screening per ICH M7 guidelines, residual solvent analysis, lactone impurity control for statins, heavy metal testing, and thorough microbiological evaluation. Each batch is certified for use in life-saving cardiovascular medications.
Our Cardiovascular APIs Products
| Product Name | CAS Number | Grade | Form | Actions |
|---|---|---|---|---|
Atorvastatin Calcium API | 134523-03-8 | IP/BP/USP | API Powder | View Product |
Sacubitril Sodium API | 149690-05-1 | IH | API Powder | View Product |
Sacubitril Valsartan API | 936623-90-4 | IH | API Powder | View Product |
Frequently Asked Questions
What are Cardiovascular APIs?
Cardiovascular APIs are active pharmaceutical ingredients used to treat heart and blood vessel diseases. They include statins for cholesterol reduction, antihypertensives for blood pressure control, anticoagulants for clot prevention, anti-arrhythmics for heart rhythm disorders, and heart failure medications. These work through various mechanisms to reduce cardiovascular mortality.
Which cardiovascular APIs does Holiness Pharmaceutical manufacture?
We manufacture Atorvastatin Calcium (statin for cholesterol lowering), along with antihypertensive APIs including ARBs and calcium channel blockers. Our cardiovascular portfolio addresses multiple aspects of heart disease management. All products meet international pharmacopeial standards and support development of evidence-based cardiovascular therapies.
Why is Atorvastatin the most prescribed statin?
Atorvastatin is highly effective at lowering LDL cholesterol and has extensive clinical evidence showing cardiovascular benefit. It has a long half-life allowing once-daily dosing, potent LDL reduction even at low doses, proven reduction in heart attacks and strokes, and excellent safety profile. These factors make it the most widely prescribed statin globally.
How do you ensure polymorphic consistency in Atorvastatin?
Atorvastatin Calcium exists in multiple polymorphic forms. We control crystallization conditions meticulously and characterize each batch using XRD, DSC, and FTIR. We maintain the most stable crystalline form throughout manufacturing and storage, ensuring consistent dissolution, bioavailability, and therapeutic effect. Polymorphic specifications are strictly maintained.
Can you provide APIs for cardiovascular combination products?
Yes, we supply APIs for fixed-dose combinations addressing multiple cardiovascular risk factors, such as statin-antihypertensive combinations. We provide compatibility studies, stability data, co-processing guidance, and regulatory support for developing combination products that simplify treatment regimens and improve patient adherence.
What is the importance of chiral purity in cardiovascular drugs?
Many cardiovascular drugs are chiral, with one enantiomer providing therapeutic benefit. We use asymmetric synthesis or chiral resolution and employ chiral HPLC to ensure enantiomeric purity >99%. This maximizes efficacy, minimizes side effects from inactive enantiomers, and ensures consistent therapeutic response in preventing heart attacks and strokes.
How do you control lactone impurities in statin APIs?
Lactone forms are key degradation products in statins. We optimize manufacturing and storage conditions to minimize lactone formation, use validated HPLC methods for sensitive detection, and maintain levels well below pharmacopeial limits. Lactone content is routinely tested and reported in Certificates of Analysis to ensure product quality.
What support do you provide for generic cardiovascular drug development?
We provide comprehensive support including comparative dissolution studies, polymorphic characterization data, impurity profiles, bioequivalence study support, stability data under ICH conditions, and regulatory documentation for ANDA filings. Our technical team assists throughout development to ensure successful generic product approval and launch.