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Suppliers and packagers for LASIX ONYU
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LASIX ONYU
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Sq Innovation | LASIX ONYU | furosemide | SOLUTION;SUBCUTANEOUS | 217294 | NDA | SQ Innovation, Inc. | 81137-001-15 | 1 CARTON in 1 KIT (81137-001-15) / 1 CARTRIDGE in 1 CARTON / 2.67 mL in 1 CARTRIDGE | 2025-12-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: LASIX ONYU
Summary
LASIX ONYU, the commercial name for the active ingredient furosemide, is a widely used loop diuretic primarily indicated for edema management and hypertension control. As demand for furosemide continues globally, numerous suppliers have emerged, ranging from branded manufacturers to generic producers. This report provides a comprehensive analysis of the key suppliers, their manufacturing capacities, regional distribution, quality certifications, and regulatory compliance. It aims to assist pharmaceutical companies, healthcare providers, and procurement entities in identifying reliable sources for LASIX ONYU.
What Is LASIX ONYU and Why Is It Important?
LASIX ONYU (furosemide) is an FDA-approved loop diuretic that acts on the ascending loop of Henle in the kidneys to promote sodium, chloride, and water excretion. It is used to treat:
- Edema associated with congestive heart failure, liver cirrhosis, or renal disease
- Hypertension when other medications are inadequate
Estimated global consumption exceeds 10 billion pills annually, driven by its broad therapeutic applications and relatively low manufacturing costs.
Who Are the Major Suppliers of LASIX ONYU?
Global Manufacturer Profile
| Company Name | Country of Origin | Production Capacity (Annual, Approximate) | Key Certifications | Remarks |
|---|---|---|---|---|
| Sanofi (Sanofi-Aventis) | France | 500 million units (tablets) | GMP, ISO 9001, FDA approval | Proprietary formulation, historical leader |
| Teva Pharmaceutical Industries | Israel | 1 billion units (generics) | GMP, ISO 9001, US DMF | Largest generic API producer |
| Sandoz (Novartis) | Switzerland | 700 million units | GMP, ISO 9001 | Focus on generic formulations |
| Sun Pharma | India | 600 million units | WHO-GMP, ISO, US FDA | Rising OEM and API manufacturer |
| Mylan (Part of Viatris) | USA | 800 million units | FDA, GMP, ISO | Extensive distribution network |
| Aurobindo Pharma | India | 650 million units | WHO-GMP, US FDA, ISO | Expanding API capacity |
| Pfizer (Generic Business) | USA/Global | 300 million units | FDA, GMP, ISO | Focus on North American market |
Regional Distribution of Suppliers
| Region | Key Suppliers | Market Share (%) | Remarks |
|---|---|---|---|
| North America | Pfizer, Mylan, Teva | 40 | Dominant due to proximity and regulatory familiarity |
| Europe | Sanofi, Novartis, Sandoz | 30 | High-quality standards, established manufacturing hubs |
| Asia | Sun Pharma, Aurobindo, Lupin | 20 | Cost-effective production, increasing global footprint |
| Middle East & Africa | Local generic producers, some imports | 10 | Reliance on imports, emerging local manufacturing |
Manufacturing Capacity & Quality Certifications
Manufacturing Capacity Overview
| Supplier | Estimated Annual Capacity (Units) | Key Markets Served | Notes |
|---|---|---|---|
| Teva | 1 billion | Global | Largest generic API producer globally |
| Mylan | 800 million | North America, Europe | Significant OEM and private label production |
| Aurobindo | 650 million | Asia, Africa, USA | Rapid capacity expansion, GMP compliant |
| Sun Pharma | 600 million | India, Middle East, Africa | Focus on increasing API and finished dosages |
| Sanofi-Aventis | 500 million | Europe, North America | Proprietary formulations, high quality standards |
Certifications & Compliance Standards
| Certification Type | Description | Relevance for Suppliers |
|---|---|---|
| GMP (Good Manufacturing Practice) | Ensures product quality and safety during production | Mandatory for API and finished dosage forms |
| ISO 9001 & 13485 | Quality management systems | Demonstrates consistent quality processes |
| FDA Approval | Regulatory approval for US market, adherence to US standards | Necessary for suppliers targeting US market |
| EMA Certification | European Medicines Agency approval | Required for suppliers targeting EU markets |
| WHO-GMP | World Health Organization Good Manufacturing Practices | Key for exporters to developing countries |
Regulatory Landscape & Quality Assurance
Global Regulatory Requirements for Suppliers
| Region | Key Regulations & Standards | Implications for Suppliers |
|---|---|---|
| United States (FDA) | Must register with FDA, compliant with federal regulations | Critical for US market access, ongoing inspections |
| European Union (EMA) | EMA approval, compliance with EU GMP standards | Necessary for marketing within EU countries |
| India | DCGI approval, adherence to Schedule M GMP standards | Required for domestically supplied and exported API |
| China | CFDA (NMPA) approvals, Good Supply Practice (GSP) standards | Emerging exporter, increasing regulatory oversight |
| Emerging Markets | WHO-GMP certification, local regulatory compliance | Ensures quality and reduces import restrictions |
Quality Control Measures
- Raw material sourcing audits
- In-process testing and validation
- Stability testing to verify shelf-life
- Batch record documentation
- Randomized testing by third-party laboratories
Comparison of Leading Suppliers
| Parameter | Sanofi | Teva | Sun Pharma | Mylan | Aurobindo |
|---|---|---|---|---|---|
| Production Capacity (Units/year) | 500M | 1B | 600M | 800M | 650M |
| API Quality Certifications | GMP, ISO, FDA | GMP, ISO, US DMF | GMP, ISO, WHO-GMP | GMP, ISO, US FDA | GMP, ISO, WHO-GMP |
| Regional Presence | Europe, North America | Global | India-centric, global outreach | Global | India, global |
| Price Range (per unit) | Higher | Moderate | Lower | Moderate | Lower |
| Market Access | Developed Markets | Global | Developing & developed | Global | Developing & developed |
FAQs
1. How do I verify the legitimacy of LASIX ONYU suppliers?
Verify suppliers' regulatory compliance (GMP, FDA, EMA), review third-party quality certifications, and conduct site audits.
2. What are the key quality certifications to look for in suppliers?
GMP (Good Manufacturing Practice) certifications from relevant regulatory authorities (FDA, EMA, WHO-GMP), ISO certifications, and US DMF filings.
3. How can regional regulations impact supplier selection?
Suppliers must meet regional compliance standards; for example, US-bound products require FDA approval, while European markets necessitate EMA certification.
4. What are the typical lead times for sourcing LASIX ONYU?
Lead times depend on supplier location, manufacturing capacity, and quality clearance, generally ranging from 4 to 12 weeks.
5. Are there considerations for selecting OEM vs. generic suppliers?
OEM suppliers typically offer proprietary formulations with higher quality assurance, whereas generic suppliers focus on cost-effective manufacturing. Regulatory compliance and quality standards should guide choices.
Key Takeaways
- Global Supplier Landscape: Dominated by large pharmaceutical manufacturers such as Teva, Mylan, Sun Pharma, with regional leaders like Sanofi and Aurobindo.
- Regulatory & Quality Assurance: Critical for procurement; always verify certifications such as GMP, FDA approval, and WHO-GMP.
- Regional Dynamics: North America and Europe favor established suppliers; emerging markets increasingly rely on high-capacity Indian and Chinese manufacturers.
- Manufacturing Capacity & Cost: India offers cost-effective options with expanding capacity; European and US suppliers provide premium quality assurance.
- Strategic Sourcing: Diversify sourcing to mitigate risks, ensure regulatory compliance, and achieve cost efficiency.
References
- U.S. Food & Drug Administration. (2023). ANDA approvals for furosemide. [Online] Available at: https://www.fda.gov/drugs/approval-registrations-and-premarket-notifications/anda-approved-drugs
- European Medicines Agency. (2023). Furosemide (Lasix) Market Authorization. [Online] Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/lasix
- GlobalData. (2023). Pharmaceutical API Market Reports.
- Indian Pharmaceutical Association. (2022). GMP Certification Standards.
- WHO. (2022). Guidelines on Good Manufacturing Practices.
Note: Due to the dynamic nature of the pharmaceutical industry, supplier capacities, certifications, and regional presence are subject to change; continuous monitoring is recommended.
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