Anti-Lipemic APIs
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About Anti-Lipemic APIs
Holiness Pharmaceutical specializes in manufacturing and exporting high-quality Anti-Lipemic APIs for cholesterol and lipid management. Our portfolio includes statins and fibrates manufactured under WHO-GMP standards, serving global pharmaceutical companies in developing medications that reduce cardiovascular risk and improve patient outcomes. We are committed to providing affordable, quality-assured lipid-lowering APIs for worldwide cardiovascular disease prevention.
Key Features
- WHO-GMP certified cardiovascular drug manufacturing
- Compliance with IP, BP, USP, and EP pharmacopeial standards
- Multiple therapeutic classes for lipid management
- Advanced chiral synthesis for enantiomerically pure products
- Comprehensive genotoxic impurity control
- Polymorphic form control and characterization
- Complete regulatory support with DMF availability
- Technical guidance for sustained-release formulations
Application Areas
Hypercholesterolemia
Primary treatment for elevated LDL cholesterol and total cholesterol levels
Cardiovascular Risk Reduction
Prevention of heart attacks, strokes, and atherosclerotic disease
Mixed Dyslipidemia
Management of combined high cholesterol and triglycerides
Familial Hypercholesterolemia
Treatment of genetic lipid disorders requiring intensive therapy
Metabolic Syndrome
Lipid management in patients with diabetes and obesity
Quality Assurance
Our anti-lipemic 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, related substances testing, and thorough microbiological evaluation. Each batch meets stringent specifications for cardiovascular pharmaceutical applications.
Our Anti-Lipemic APIs Products
| Product Name | CAS Number | Grade | Form | Actions |
|---|---|---|---|---|
Fenofibrate API | 49562-28-9 | IP/BP/EP/USP | API Powder | View Product |
Rosuvastatin Calcium API | 147098-20-2 | IP/BP/EP/USP | API Powder | View Product |
Frequently Asked Questions
What are Anti-Lipemic APIs?
Anti-Lipemic APIs are active pharmaceutical ingredients that lower cholesterol and lipid levels in the blood, reducing cardiovascular disease risk. They include statins (HMG-CoA reductase inhibitors) that reduce cholesterol synthesis, and fibrates that lower triglycerides and increase HDL cholesterol through different mechanisms.
Which anti-lipemic APIs does Holiness Pharmaceutical manufacture?
We manufacture Atorvastatin Calcium (statin), Rosuvastatin Calcium (statin), and Fenofibrate (fibrate). All products are manufactured to international pharmacopeial standards with strict control over chirality, polymorphic form, and impurity profiles to ensure optimal therapeutic efficacy.
What is the difference between statins and fibrates?
Statins primarily lower LDL cholesterol and total cholesterol by inhibiting HMG-CoA reductase enzyme. Fibrates mainly reduce triglycerides and increase HDL cholesterol by activating PPAR-alpha receptors. Statins are first-line for high cholesterol, while fibrates are preferred for high triglycerides. Sometimes both are used together for mixed dyslipidemia.
Why is polymorphic control critical for statin APIs?
Different polymorphic forms have varying solubility, dissolution rates, and bioavailability. For example, Atorvastatin Calcium exists in multiple forms, and consistent polymorphic form ensures reproducible therapeutic effect. We control polymorph through crystallization conditions and verify using XRD, DSC, and FTIR, maintaining specifications throughout shelf life.
How do you ensure chiral purity in statin APIs?
Statins like Atorvastatin and Rosuvastatin are chiral molecules where only specific enantiomers are therapeutically active. We use asymmetric synthesis or chiral resolution followed by chiral HPLC analysis to ensure enantiomeric excess >99%. This ensures maximum efficacy and minimizes potential side effects from inactive enantiomers.
Do you control lactone impurities in statin APIs?
Yes, lactone forms are important degradation products and related substances in statins. We implement strict process controls to minimize lactone formation and use validated HPLC methods to monitor and control these impurities within pharmacopeial limits. Lactone content is routinely tested and reported in Certificates of Analysis.
Can you provide APIs for combination products with anti-hypertensives?
Yes, we supply anti-lipemic APIs compatible with combination products such as Atorvastatin-Amlodipine. We provide compatibility studies, co-processing guidelines, and technical support for developing stable fixed-dose combinations that address both cardiovascular risk factors simultaneously.
What are the storage requirements for anti-lipemic APIs?
Most anti-lipemic APIs should be stored in tightly closed, light-resistant containers at controlled room temperature (20-25°C) with protection from moisture. Statins particularly require protection from hydrolysis. Detailed storage conditions, retest periods, and stability data under various conditions are provided with each batch's documentation.