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Suppliers and packagers for BENAZEPRIL HYDROCHLORIDE
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BENAZEPRIL HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharms | BENAZEPRIL HYDROCHLORIDE | benazepril hydrochloride | TABLET;ORAL | 076820 | ANDA | AvPAK | 50268-109-15 | 50 BLISTER PACK in 1 BOX (50268-109-15) / 1 TABLET in 1 BLISTER PACK (50268-109-11) | 2014-04-28 |
| Amneal Pharms | BENAZEPRIL HYDROCHLORIDE | benazepril hydrochloride | TABLET;ORAL | 076820 | ANDA | AvPAK | 50268-110-15 | 50 BLISTER PACK in 1 BOX (50268-110-15) / 1 TABLET in 1 BLISTER PACK (50268-110-11) | 2014-04-28 |
| Amneal Pharms | BENAZEPRIL HYDROCHLORIDE | benazepril hydrochloride | TABLET;ORAL | 076820 | ANDA | AvPAK | 50268-111-15 | 50 BLISTER PACK in 1 BOX (50268-111-15) / 1 TABLET in 1 BLISTER PACK (50268-111-11) | 2014-04-28 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Benazepril Hydrochloride
Introduction
Benazepril hydrochloride is a potent antihypertensive medication belonging to the angiotensin-converting enzyme (ACE) inhibitor class. Widely prescribed for managing hypertension and heart failure, its global demand underscores the importance of a reliable and high-quality supply chain. This article provides an in-depth analysis of primary suppliers, manufacturing sources, and market dynamics associated with benazepril hydrochloride, equipping business professionals with critical insights to support procurement strategies, market analysis, and regulatory compliance.
Understanding Benazepril Hydrochloride
Benazepril hydrochloride acts by inhibiting the renin-angiotensin-aldosterone system, resulting in vasodilation and lowered blood pressure. It is synthesized through complex chemical processes requiring high-quality raw materials, precise manufacturing conditions, and strict quality control, making the selection of reputable suppliers crucial.
The global market for benazepril hydrochloride is driven by growing cardiovascular disease prevalence, aging populations, and increasing awareness of hypertension management. The market is predominantly supplied by a combination of international API (Active Pharmaceutical Ingredient) manufacturers and local suppliers, with key players focusing on regulatory compliance and manufacturing excellence.
Major Suppliers of Benazepril Hydrochloride
1. International API Manufacturers
a. Zhejiang Huahong Pharmaceutical Co., Ltd.
Based in China, Zhejiang Huahong is a leading pharmaceutical ingredient manufacturer specializing in ACE inhibitors, including benazepril hydrochloride. Known for competitive pricing and robust quality management systems, it caters to global markets through extensive export channels [1].
b. Zhejiang Conba Pharmaceutical Co., Ltd.
Another Chinese company, Conba Pharmaceutical, supplies high-purity benazepril hydrochloride. The company emphasizes compliance with international standards like GMP, FDA, and EMA, making it a trusted source for multinational pharmaceutical companies [2].
c. Zhejiang Singclean Medical Product Co., Ltd.
Focusing on ingredient synthesis, this enterprise supplies benazepril hydrochloride with consistent batch quality, backed by extensive quality assurance systems aligned with global regulatory requirements [3].
2. India-based API Suppliers
a. Laurus Labs
Recognized as a prominent API manufacturer, Laurus Labs offers benazepril hydrochloride with a focus on quality, cost-efficiency, and regulatory compliance. The company has received approvals from major regulatory bodies and emphasizes sustainable manufacturing practices [4].
b. Hetero Labs Limited
Hetero is a major player in the Indian pharmaceutical sector, providing high-quality benazepril hydrochloride API. Its manufacturing facilities are GMP-certified, and the company invests in R&D to improve API quality and process efficiency [5].
3. Other Notable Regional Suppliers
a. Popular Pharmaceuticals (South Korea)
Specializing in cardiovascular APIs, Popular Pharmaceuticals supplies benazepril hydrochloride with a focus on East Asian markets, emphasizing stringent quality standards and technological innovation [6].
b. Teva Pharmaceuticals (Israel)
As a global pharmaceutical giant, Teva manufactures and supplies benazepril hydrochloride API as part of its cardiovascular product portfolio, adhering to rigorous international quality and regulatory standards [7].
4. Contract Manufacturing and Exporters
Many pharmaceutical companies globally contract third-party manufacturers for benazepril hydrochloride production, especially in China and India, to meet specific quality, pricing, and supply timeline requirements. These smaller entities often serve as intermediaries, facilitating the global distribution network.
Market Dynamics and Supply Chain Considerations
Regulatory Compliance
Suppliers must adhere to GMP, FDA, EMA, and other international standards. Manufacturers with certified facilities are preferred for their ability to ensure batch-to-batch consistency and facilitate regulatory approvals in multiple jurisdictions.
Quality and Purity Standards
The efficacy of benazepril hydrochloride depends heavily on chemical purity, stability, and batch reliability. ISO certifications, quality audits, and raw material sourcing transparency are critical evaluations criteria.
Pricing and Availability
Pricing varies significantly between regions, influenced by manufacturing costs, regulatory burdens, and supply chain logistics. Chinese and Indian suppliers generally offer more competitive prices, but supply chain risks such as geopolitical tensions, export restrictions, and manufacturing quality concerns must be considered.
Supply Risks and Mitigation
Dependence on a limited number of suppliers risks supply disruptions. Diversification strategies, establishing multiple supplier relationships, and vetting suppliers for compliance and capacity are essential risk-mitigation practices.
Emerging Trends and Future Outlook
The pharmaceutical supply chain for benazepril hydrochloride is increasingly influenced by factors such as:
- Regulatory harmonization: Enhanced global standards push suppliers to adopt stricter quality measures.
- Manufacturing innovations: Advances in synthesis and process efficiency improve supply stability and cost-effectiveness.
- Supply chain resilience: The COVID-19 pandemic underscored the importance of diversified sourcing and local manufacturing capabilities.
- Sustainability initiatives: Regulatory and consumer demands for environmentally sustainable practices influence supplier selection.
Key Suppliers Summary Table
| Supplier | Location | Certification | Market Focus | Notable Strengths |
|---|---|---|---|---|
| Zhejiang Huahong Pharmaceutical | China | GMP, ISO | Global | Cost-efficient, large capacity |
| Zhejiang Conba Pharmaceutical | China | GMP, FDA | Global | High-quality standards |
| Laurus Labs | India | GMP, US DMF | Global | Cost-effectiveness, R&D focus |
| Hetero Labs | India | GMP | India, Export | Scale, regulatory compliance |
| Popular Pharmaceuticals | South Korea | GMP | Asia-Pacific | Focused regional supply |
| Teva Pharmaceuticals | Israel | GMP, FDA | Global | Brand reputation, quality assurance |
Conclusion
The supply landscape for benazepril hydrochloride predominantly involves manufacturers from China, India, and select regions, driven by cost efficiency and regulatory compliance. Reliable sourcing requires assessing supplier certification, manufacturing capacity, and compliance with international standards. As market demand intensifies, suppliers investing in quality assurance, sustainable practices, and process innovation will secure competitive advantages. Engaging with diversified, certified, and transparent suppliers is critical for pharmaceutical companies to sustain reliable supply chains and meet regulatory requirements.
Key Takeaways
- Global Supplier Diversity: Suppliers from China, India, South Korea, and Israel dominate, offering competitive pricing and high standards.
- Regulatory Certification Is Critical: GMP, FDA, and EMA approvals are key indicators of supplier reliability.
- Quality Assurance: High chemical purity, batch consistency, and transparency in raw material sourcing are non-negotiable.
- Supply Chain Resilience: Diversify suppliers to minimize risks linked to geopolitical, regulatory, or manufacturing disruptions.
- Future Trends: Emphasis on sustainability, technological innovation, and regulatory harmonization will shape supplier dynamics.
FAQs
1. What are the main factors to consider when selecting a benazepril hydrochloride supplier?
Quality certifications (GMP, FDA, EMA), manufacturing capacity, compliance record, cost-effectiveness, and supply chain reliability are primary considerations.
2. Are Chinese suppliers of benazepril hydrochloride reliable?
Many Chinese manufacturers possess GMP certification and export extensive quantities globally; however, due diligence in audits and certifications is recommended for assurance of quality and compliance.
3. How does regulatory compliance impact supplier choice?
Suppliers with recognized certifications streamline approval processes and reduce regulatory risks, ensuring smoother market entry and ongoing compliance.
4. What are the risks of relying on a single supplier for benazepril hydrochloride?
Supply disruptions, quality inconsistencies, and regulatory issues can arise; diversification mitigates these risks and ensures supply continuity.
5. How is the market changing with new manufacturing technologies?
Innovations in chemical synthesis and process engineering improve API purity, reduce costs, and enhance supply stability, benefitting both suppliers and end-users.
Sources:
[1] Zhejiang Huahong Pharmaceutical official site.
[2] Zhejiang Conba Pharmaceutical Reports.
[3] Zhejiang Singclean Medical Product Co., Ltd. Publications.
[4] Laurus Labs Annual Report.
[5] Hetero Labs Corporate Profile.
[6] Popular Pharmaceuticals Product Portfolio.
[7] Teva Pharmaceuticals API Manufacturing Overview.
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