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Suppliers and packagers for generic pharmaceutical drug: HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
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HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Azurity | BIDIL | hydralazine hydrochloride; isosorbide dinitrate | TABLET;ORAL | 020727 | NDA | Azurity | 24338-010-09 | 90 TABLET, FILM COATED in 1 BOTTLE (24338-010-09) | 2012-12-05 |
| Azurity | BIDIL | hydralazine hydrochloride; isosorbide dinitrate | TABLET;ORAL | 020727 | NDA AUTHORIZED GENERIC | Wilshire Pharmaceuticals | 52536-006-09 | 90 TABLET, FILM COATED in 1 BOTTLE (52536-006-09) | 2022-04-15 |
| Azurity | BIDIL | hydralazine hydrochloride; isosorbide dinitrate | TABLET;ORAL | 020727 | NDA AUTHORIZED GENERIC | Bryant Ranch Prepack | 72162-2343-9 | 90 TABLET, FILM COATED in 1 BOTTLE (72162-2343-9) | 2022-04-15 |
| I3 Pharms | ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride; isosorbide dinitrate | TABLET;ORAL | 215988 | ANDA | i3 Pharmaceuticals, LLC | 72319-012-03 | 90 TABLET, FILM COATED in 1 BOTTLE (72319-012-03) | 2024-02-07 |
| I3 Pharms | ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride; isosorbide dinitrate | TABLET;ORAL | 215988 | ANDA | i3 Pharmaceuticals, LLC | 72319-012-18 | 180 TABLET, FILM COATED in 1 BOTTLE (72319-012-18) | 2024-02-07 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Hydralazine Hydrochloride and Isosorbide Dinitrate: A Comprehensive Analysis of Global Suppliers and Therapeutic Applications
The pharmaceutical industry relies heavily on a robust supply chain for active pharmaceutical ingredients (APIs) to ensure consistent drug production. Hydralazine Hydrochloride and Isosorbide Dinitrate, two critical cardiovascular agents, exemplify this dynamic. Hydralazine Hydrochloride, a direct-acting vasodilator, and Isosorbide Dinitrate, a nitrate vasodilator, are used both individually and in combination to manage hypertension and heart failure. This report examines the global supplier landscape for these APIs, highlighting key manufacturers, regulatory frameworks, pricing dynamics, and the growing role of combination therapies. With major suppliers spanning India, Italy, Japan, and the United States, the market is characterized by stringent regulatory compliance and competitive pricing strategies.
Therapeutic Applications and Clinical Significance
Pharmacological Mechanisms
Hydralazine Hydrochloride acts by relaxing arterial smooth muscle, reducing systemic vascular resistance and blood pressure[7][15]. Isosorbide Dinitrate, a nitric oxide donor, dilates veins and arteries, decreasing cardiac preload and afterload[10][15]. Their complementary mechanisms make them effective in combination therapies, particularly for heart failure in specific patient populations[14][15].
Clinical Use Cases
While Hydralazine Hydrochloride is often reserved for resistant hypertension, Isosorbide Dinitrate is a mainstay in angina management. The combination product BiDil (Hydralazine/Isosorbide Dinitrate) gained FDA approval in 2005 for heart failure in Black Americans, underscoring the importance of tailored therapies[14][15]. This combination improves survival rates and reduces hospitalization, demonstrating the synergistic potential of these APIs[10][14].
Hydralazine Hydrochloride Supplier Landscape
Key Manufacturers and Suppliers
The global supply of Hydralazine Hydrochloride is dominated by manufacturers in India, Italy, and the United States. Cohance Lifesciences and Neuland Laboratories in India produce the API under strict Good Manufacturing Practices (GMP), catering to both domestic and international markets[1][9]. Archimica, based in Italy, stands out for its large-scale production capabilities and compliance with U.S. Drug Master Files (DMF) and European regulations[4]. In the U.S., LGM Pharma and NAVINTA distribute Hydralazine Hydrochloride, often sourcing from international partners[2][6].
Regulatory and Quality Compliance
Manufacturers must adhere to pharmacopeial standards (USP, EP) and maintain DMFs for regulatory filings. Archimica’s facility in Lodi, Italy, exemplifies this compliance, with its hydrazine-based synthesis process meeting environmental and safety guidelines[4]. Indian suppliers like DK Pharmachem emphasize USDMF filings (e.g., DMF No. 021953) to access regulated markets[7].
Pricing Dynamics
Hydralazine Hydrochloride prices fluctuate based on raw material costs, regulatory changes, and negotiated contracts. PharmaCompass reports non-binding prices influenced by market volatility, with Indian suppliers often offering competitive rates due to lower production costs[1][9]. For instance, Tenatra Exports Private Limited in India provides the API at scales ranging from kilograms to metric tons, leveraging economies of scale[11].
Isosorbide Dinitrate Supplier Landscape
Key Manufacturers and Suppliers
Isosorbide Dinitrate production is concentrated in India, Japan, and Europe. Sumitomo Chemical in Japan and Dipharma in Italy are renowned for high-purity batches compliant with USP and EP monographs[3][8]. Indian companies like Johnlee Pharmaceuticals and Actiza Pharmaceutical supply cost-effective variants, often exporting to North America and Africa[12][16]. Torrent Pharmaceuticals leads in volume, accounting for 28% of global exports[16].
Regulatory and Quality Compliance
Suppliers must navigate complex certifications, including GMP and ISO. DOTTIKON EXCLUSIVE SYNTHESIS AG in Switzerland highlights its adherence to ICH guidelines, ensuring traceability and batch consistency[3]. The FDA’s scrutiny of nitrosamine impurities in nitrates has further tightened quality controls, prompting investments in advanced analytics[3][5].
Pricing Dynamics
Isosorbide Dinitrate prices range from $0.50 to $0.90 per box, influenced by dosage form and regional demand[12]. Indian exporters like Rubicon Research offer bulk discounts, while European manufacturers prioritize premium pricing for GMP-certified APIs[3][16]. The entry of generic versions post-patent expiry has intensified price competition, particularly in emerging markets[5][12].
Geographic Distribution and Regional Suppliers
Asia-Pacific Dominance
India’s pharmaceutical sector commands 35% of global Isosorbide Dinitrate exports, driven by firms like Torrent Pharmaceuticals and Hetero Labs[16]. China’s growing API industry, though less prominent in these specific drugs, provides intermediates for downstream synthesis[16].
European Excellence
Italy’s Archimica and Euticals exemplify Europe’s focus on high-margin, high-quality APIs, targeting regulated markets[4][8]. Their facilities emphasize sustainable practices, such as Archimica’s closed-loop solvent recovery systems[4].
North American Networks
U.S. distributors like LGM Pharma bridge domestic demand and international supply chains, often partnering with Indian manufacturers to balance cost and compliance[2][6]. Arbor Pharmaceuticals, a subsidiary of Azurity, markets the combination therapy BiDil, relying on contracted API suppliers[14].
Combination Therapy: Hydrozolin ISDN and BiDil
Formulation and Market Impact
The fixed-dose combination Hydrozolin ISDN (20 mg Isosorbide Dinitrate/37.5 mg Hydralazine) simplifies dosing for heart failure patients[10]. BiDil, despite its narrow indication, remains a landmark in ethnically tailored medicine, generating $50 million annually[14]. Suppliers like Wilshire Pharma and Arbor Pharmaceuticals leverage multi-source APIs to mitigate supply risks[6][14].
Manufacturing Challenges
Combining two APIs requires stringent stability testing and compatibility studies. Archimica addresses this by offering co-processed APIs with matched particle sizes and dissolution profiles[4]. Regulatory hurdles, such as the FDA’s requirement for bioavailability studies, further complicate production[14][15].
Economic and Market Considerations
Cost Drivers
- Raw Materials: Hydrazine derivatives for Hydralazine and nitric acid precursors for Isosorbide influence input costs[4][8].
- Regulatory Updates: Nitrosamine limits under ICH M7(R1) guidelines have increased testing costs by 15–20%[3][5].
- Logistics: Geographic disruptions (e.g., Red Sea shipping delays) elevate freight expenses, particularly for Indian exports to the U.S.[16].
Competitive Strategies
Suppliers differentiate through:
- Vertical Integration: Neuland Laboratories controls synthesis from intermediates to finished APIs, reducing lead times[1][9].
- Portfolio Diversification: Sumitomo Chemical offers Isosorbide Dinitrate in multiple grades (e.g., USP, EP) to serve generics and innovators[3][8].
Future Outlook and Emerging Trends
Biopharmaceutical Innovations
Next-generation nitrates with reduced tolerance profiles may displace Isosorbide Dinitrate in chronic use[15]. Conversely, Hydralazine’s repurposing potential in pulmonary hypertension is under investigation, which could spur API demand[7][14].
Supply Chain Resilience
The COVID-19 pandemic underscored vulnerabilities in API sourcing, prompting regions like the EU to incentivize local production[4][8]. India’s Production-Linked Incentive (PLI) scheme aims to bolster self-sufficiency, benefiting suppliers like Cohance Lifesciences[1][16].
Sustainability Initiatives
Green chemistry advancements, such as Archimica’s solvent-free synthesis of Hydralazine, align with ESG goals and reduce manufacturing costs by 12–18%[4]. Carbon-neutral certifications are becoming a competitive edge in tenders for public health systems[3][8].
Conclusion
The global supplier ecosystem for Hydralazine Hydrochloride and Isosorbide Dinitrate is marked by geographic specialization, regulatory rigor, and evolving market demands. While Indian manufacturers dominate volume, European and U.S. firms excel in quality and innovation. Combination therapies like BiDil highlight the need for integrated supply chains and collaborative regulatory strategies. As cardiovascular disease prevalence rises, suppliers must balance cost-efficiency with sustainability and adaptability to maintain market relevance.
Key Takeaways
- Hydralazine Hydrochloride and Isosorbide Dinitrate are critical for hypertension and heart failure, with combination therapies gaining traction.
- India leads in API production, while Europe and the U.S. focus on high-quality, regulated outputs.
- Regulatory compliance and sustainability initiatives are pivotal for competitive advantage.
- Future trends include biopharmaceutical innovation and supply chain localization.
FAQs
-
What certifications are essential for Hydralazine Hydrochloride suppliers?
Suppliers require USDMF, GMP, and pharmacopeial compliance (USP/EP)[1][4][7]. -
How does Isosorbide Dinitrate pricing vary by region?
Indian APIs cost $0.50–$0.90/box, while European variants command premiums up to $1.20[3][12][16]. -
Which companies produce the Hydralazine/Isosorbide combination?
Arbor Pharmaceuticals (BiDil) and Wilshire Pharma (Hydrozolin ISDN) are key players[6][14]. -
What are the main challenges in API manufacturing?
Nitrosamine contamination and raw material volatility are major hurdles[3][5]. -
How is sustainability influencing API production?
Green chemistry and solvent-free processes reduce costs and environmental impact[4][8].
References
- https://www.pharmacompass.com/manufacturers-suppliers-exporters/hydralazine-hydrochloride
- https://pharmaoffer.com/api-excipient-supplier/vasodilators/hydralazine
- https://www.pharmacompass.com/manufacturers-suppliers-exporters/isosorbide-dinitrate
- https://www.archimica.com/hydralazine-hydrochloride-api-grade/
- https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/isosorbide-dinitrate
- https://pharmacy.amazon.com/Hydralazine-Isosorbide-Dinitrate-Generic-for-Bidil-Oral-Tablet/dp/B09YTZP3RW
- https://www.dkpharmachem.com/hydralazine-hydrochloride-manufacturers-supplier-exporter.html
- https://www.pharmacompass.com/manufacturers-suppliers-exporters/d-isosorbide-dinitrate
- https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/hydralazine-hydrochloride
- https://www.sterisonline.com/blog/isosorbide-dinitrate-20mg-hydralazine-37-5mg
- https://pharmaoffer.com/api-excipient-supplier/hydralazine-hydrochloride
- https://www.tradeindia.com/manufacturers/isosorbide-dinitrate.html
- https://www.universaldrugstore.com/medications/isosorbide-dinitrate-hydralazine-hydrochloride/
- https://adisinsight.springer.com/drugs/800020118
- https://www.mayoclinic.org/drugs-supplements/isosorbide-dinitrate-and-hydralazine-oral-route/description/drg-20138501
- https://www.volza.com/p/isosorbide/manufacturers/cod-united-states/
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