Alfuzosin Hydrochloride API (CAS No: 81403-68-1): Complete Guide for Pharmaceutical Applications
Introduction to Alfuzosin Hydrochloride API
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| Alfuzosin-Hydrochloride-API-CAS-No-81403-68-1-Complete-Guide-for-Pharmaceutical-Applications |
Alfuzosin Hydrochloride is widely used in medications designed to treat benign prostatic hyperplasia (BPH), a condition that affects millions of men globally. The rising aging population has significantly increased the demand for effective and safe treatment options, thereby boosting the global market for Alfuzosin-based drugs. Pharmaceutical companies are constantly seeking bulk Alfuzosin Hydrochloride manufacturer suppliers in India that can deliver consistent quality, regulatory compliance, and cost-effective solutions.
In this detailed guide, we will explore everything you need to know about Alfuzosin Hydrochloride API—from its chemical profile to manufacturing, applications, and market trends—while helping you understand why choosing the right supplier is crucial for long-term success.
What is Alfuzosin Hydrochloride API
Alfuzosin Hydrochloride is a selective alpha-1 adrenergic receptor antagonist, primarily used in the treatment of urinary symptoms associated with benign prostatic hyperplasia. It works by relaxing the muscles in the prostate and bladder neck, thereby improving urine flow and reducing symptoms such as difficulty in urination.
Pharmacological Classification
Alfuzosin belongs to the class of alpha-blockers, which are widely used in urology. Unlike non-selective alpha blockers, Alfuzosin offers improved tolerability and fewer cardiovascular side effects, making it a preferred choice in modern formulations. This has led to increased demand among pharmaceutical manufacturers looking for reliable pharmaceutical Alfuzosin Hydrochloride manufacturer suppliers.
Mechanism of Action
The drug selectively blocks alpha-1 receptors in the lower urinary tract, which helps reduce urethral resistance. This targeted mechanism ensures effective symptom relief without significantly affecting blood pressure, making it suitable for long-term therapy.
Key Chemical / Technical Information
CAS Number and Molecular Formula
- CAS Number: 81403-68-1
- Molecular Formula: C19H27N5O4·HCl
- Molecular Weight: Approximately 425.9 g/mol
These specifications are critical for pharmaceutical companies to ensure regulatory compliance and formulation accuracy when sourcing from a bulk Alfuzosin Hydrochloride manufacturer supplier in India.
Structural Characteristics
Alfuzosin Hydrochloride is characterized by a quinazoline-based structure, which contributes to its selective receptor binding properties. Its chemical configuration ensures stability and effectiveness in controlled-release formulations.
Properties and Composition
Physical Properties
Alfuzosin Hydrochloride typically appears as a white to off-white crystalline powder. It is slightly soluble in water and exhibits good stability under standard storage conditions. These properties make it suitable for various oral dosage forms, including tablets and extended-release formulations.
Chemical Stability
The compound demonstrates strong chemical stability under recommended conditions, but like most APIs, it must be protected from excessive moisture and light. Maintaining stability is essential for ensuring product efficacy and shelf life.
Benefits and Functional Advantages
One of the key reasons Alfuzosin Hydrochloride is widely used in pharmaceuticals is its excellent therapeutic profile. It provides effective symptom relief with minimal side effects, which enhances patient compliance. Additionally, it supports once-daily dosing in extended-release formulations, making it convenient for patients.
From a manufacturing perspective, the API offers consistent performance in formulation processes. Pharmaceutical companies prefer sourcing from Alfuzosin Hydrochloride supplier in Maharashtra India due to the availability of high-quality raw materials and advanced manufacturing infrastructure.
Applications / Uses in Industry
Pharmaceutical Formulations
Alfuzosin Hydrochloride is primarily used in the development of oral dosage forms such as:
- Immediate-release tablets
- Extended-release tablets
- Controlled-release formulations
These formulations are widely prescribed in the treatment of urinary disorders.
Therapeutic Applications
The API is extensively used for managing benign prostatic hyperplasia (BPH). Its ability to improve urinary flow and reduce discomfort makes it an essential component in urology medications.
Manufacturing Process Overview
Synthesis Pathway
The manufacturing of Alfuzosin Hydrochloride involves multi-step organic synthesis, starting from specific intermediates and undergoing controlled chemical reactions. The process requires precision, advanced technology, and adherence to strict quality standards to ensure purity and consistency.
Quality Control in Manufacturing
Quality control plays a vital role in API production. Key testing parameters include:
- Assay determination using HPLC
- Identification tests
- Impurity profiling
- Residual solvent analysis
- Stability studies
Reliable manufacturers ensure that every batch meets global pharmacopeial standards.
Market Demand and Trends (India + Global)
The global demand for Alfuzosin Hydrochloride API is steadily increasing due to the rising prevalence of BPH and the aging population. India has become a major hub for API manufacturing, offering cost-effective production and high-quality standards.
Pharmaceutical companies worldwide are actively sourcing from Alfuzosin Hydrochloride manufacturer supplier in India due to competitive pricing, regulatory compliance, and strong export capabilities. The Indian API market is expected to grow significantly, driven by increasing exports and domestic demand.
Quality Standards and Compliance
Ensuring compliance with international standards is critical in API manufacturing. Alfuzosin Hydrochloride must meet specifications outlined in pharmacopeias such as IP, BP, USP, and EP. Additionally, manufacturers must adhere to WHO-GMP and ICH guidelines.
Documentation such as COA, MSDS, and DMF is essential for regulatory approval and market acceptance. Pharmaceutical companies prefer suppliers who provide complete technical support and documentation.
Packaging, Storage and Stability
Proper packaging is essential to maintain the quality and stability of Alfuzosin Hydrochloride API. It is typically packed in high-quality HDPE drums with inner liners to protect against contamination and moisture.
Storage conditions should include:
- Cool and dry environment
- Protection from light
- Controlled humidity
Following these guidelines ensures long shelf life and consistent performance in formulations.
Why Choosing the Right Manufacturer Supplier Matters
Selecting the right supplier can significantly impact product quality, regulatory compliance, and overall business success. A reliable bulk Alfuzosin Hydrochloride manufacturer supplier in India ensures:
- Consistent quality and purity
- Timely delivery
- Competitive pricing
- Regulatory support
- Technical expertise
Partnering with a trusted supplier helps pharmaceutical companies avoid risks such as batch failures, regulatory issues, and supply chain disruptions.
Company Overview
Swapnroop Drugs and Pharmaceuticals is a leading pharmaceutical raw materials manufacturer and exporter based in Maharashtra, India, offering a comprehensive portfolio of APIs, excipients, pellets, and granules. The company supports pharmaceutical and biotech industries with high-quality, GMP-compliant products designed to meet international standards.
Our strong distribution network enables us to supply APIs across major pharmaceutical hubs—including Mumbai, Pune, Nagpur, Nashik, Thane, Ahmedabad, Vadodara, Ankleshwar, Surat, Hyderabad, Bangalore, Chennai, Visakhapatnam, New Delhi, Noida, Gurgaon, Chandigarh, Baddi, Haridwar, Indore, Kolkata, and Bhubaneswar—across India and globally.
With advanced manufacturing practices and strict quality control systems, Swapnroop Drugs ensures consistency, purity, and regulatory compliance across its product range. We are recognized as a trusted API manufacturer and supplier in India and worldwide, known for consistent quality, competitive pricing, and reliable logistics support.
We specialize in bulk API supply for pharmaceutical companies and traders across India and global markets, with ready stock availability. Our diverse portfolio serves multiple therapeutic segments, helping pharmaceutical companies accelerate drug development and production. As a reliable name in the pharmaceutical industry, Swapnroop Drugs continues to expand its global presence through innovation, quality assurance, and customer satisfaction.
Conclusion
Alfuzosin Hydrochloride API plays a crucial role in modern pharmaceutical formulations, particularly in the treatment of urological disorders. Its effectiveness, safety profile, and versatility make it a preferred choice for manufacturers worldwide. With the growing demand for high-quality APIs, sourcing from a trusted supplier is more important than ever.
India continues to dominate the global API market, offering unmatched advantages in terms of cost, quality, and scalability. By partnering with a reliable manufacturer like Swapnroop Drugs and Pharmaceuticals, companies can ensure consistent supply, regulatory compliance, and long-term success.
FAQs
Alfuzosin Hydrochloride API Manufacturer Supplier in India (City Coverage)
We are a trusted Alfuzosin Hydrochloride API manufacturer supplier in India, offering high-quality products with reliable bulk supply, consistent quality, and timely delivery across major industrial and pharmaceutical hubs.
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