lasix: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Validus Pharms	LASIX	furosemide	TABLET;ORAL	016273	NDA	Validus Pharmaceuticals LLC	30698-060-01	100 TABLET in 1 BOTTLE (30698-060-01)	1978-04-24
Validus Pharms	LASIX	furosemide	TABLET;ORAL	016273	NDA	Validus Pharmaceuticals LLC	30698-060-10	1000 TABLET in 1 BOTTLE (30698-060-10)	1978-04-24
Validus Pharms	LASIX	furosemide	TABLET;ORAL	016273	NDA	Validus Pharmaceuticals LLC	30698-060-50	500 TABLET in 1 BOTTLE (30698-060-50)	1978-04-24
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: October 9, 2025

Introduction

Lasix, known generically as furosemide, is a potent loop diuretic widely used in the treatment of edema associated with congestive heart failure, liver cirrhosis, and renal disease, as well as hypertension management. As a critical medication with high demand globally, an extensive network of suppliers across manufacturing, distribution, and API (Active Pharmaceutical Ingredient) production plays a vital role in ensuring its availability and affordability. This article provides a comprehensive overview of Lasix's primary suppliers, emphasizing their manufacturing capabilities, regulatory compliance, and market positioning.

Manufacturers of Furosemide API

The foundation of Lasix production lies in the synthesis of its API, furosemide. Several pharmaceutical companies globally specialize in the manufacturing of high-quality furosemide APIs, often supplying to generic drug producers, branded drug companies, and contract manufacturing organizations (CMOs).

Major API Suppliers

Jiangsu Hengrui Medicine Co., Ltd. (China)
- Hengrui is among the leading manufacturers of furosemide API in China. The company boasts extensive R&D capabilities and a robust production process compliant with Good Manufacturing Practices (GMP). Their API meets both domestic and international standards, supporting supply to global markets, including the US, EU, and emerging economies.
Shandong Xinhua Pharmaceutical Co., Ltd. (China)
- As a longstanding producer, Shandong Xinhua supplies high-grade furosemide API. Their manufacturing facilities are GMP-certified, and the company is recognized for consistent quality and competitive pricing, making their APIs attractive to generic drug manufacturers.
K+S Aktiengesellschaft (Germany)
- Known primarily as a chemical company, K+S manufactures chemical intermediates including APIs used in diuretic drugs. Their European manufacturing infrastructure ensures compliance with strict regulatory standards, and their APIs are supplied to numerous European generic producers.
Sandoz (Novartis Group, Switzerland)
- Sandoz is a global leader in generic pharmaceuticals and supplies furosemide API for their own formulations and third-party clients. Their API production benefits from Novartis’s extensive R&D and quality assurance systems.
Shenzhen Southwest Pharmaceutical Co., Ltd. (China)
- A rapidly expanding manufacturer specializing in various APIs, including furosemide, with GMP-certified facilities and an established international distribution network.

Key Considerations for API Suppliers

Regulatory Compliance: WHO-GMP, US FDA, EMA approvals indicative of production quality.
Scale: Production capacities vary; large-scale facilities ensure stable supply.
Certifications: Certificates of Analysis (CoA), Certificates of Suitability (CEP), and Drug Master Files (DMF) are critical for validation.
Pricing & Lead Times: Competitive pricing often correlates with manufacturing scale and location.

Global Distribution and Finished Drug Manufacturers

While API suppliers are essential, the finished drug manufacturing and distribution are managed by both large pharmaceutical companies and numerous regional generic manufacturers.

Key Finished Product Suppliers

Pfizer Inc.
- As the original patent holder, Pfizer manufactures branded Lasix, along with licensing agreements for generic production in various jurisdictions. Their distribution network ensures availability across North America and Europe.
Teva Pharmaceutical Industries Ltd. (Israel)
- A dominant player in generics, Teva produces and markets furosemide tablets worldwide. Their extensive manufacturing facilities and global distribution channels make them a major supplier.
Sandoz (Novartis Group)
- As a top producer of generics, Sandoz offers furosemide in multiple dosage forms, supported by global distribution infrastructure.
Mylan (Viant, now part of Viatris)
- Mylan specializes in affordable generics, making furosemide accessible in numerous markets, especially in developing economies.
Aurobindo Pharma, Dr. Reddy’s Laboratories, and Cipla (India)
- These Indian pharmaceutical giants serve as major regional suppliers for both the Asian and African markets, ensuring a steady supply of affordable Lasix formulations.

Regulatory and Quality Assurance

Manufacturers of finished Lasix products must conform to local regulatory agencies’ standards, notably:

US FDA (for the United States)
EMA (European Union)
TGA (Therapeutic Goods Administration, Australia)
Central Drugs Standard Control Organization (CDSCO) in India

Compliance enables smooth market access, maintains drug safety, and minimizes supply disruptions.

Distribution Channels and Contract Manufacturing

Many pharmaceutical companies rely on Contract Manufacturing Organizations (CMOs) to produce Lasix formulations, especially in regions where local manufacturing capabilities are limited. CMOs offering formulation development, bottling, packaging, and distribution services include:

Patheon (Thermo Fisher Scientific)
Catalent
Recipharm
Famar

Such partnerships enable brand owners to scale production quickly and adapt to demand fluctuations efficiently.

Emerging Markets and Supply Chain Dynamics

Emerging markets represent significant growth avenues for Lasix suppliers. Countries like India, China, Brazil, and parts of Africa have seen increased demand, driven by expanding healthcare infrastructure and the cost-effectiveness of generics. The supply chain relies on a combination of local manufacturing and importation of APIs and finished products, with geopolitical factors influencing raw material availability and pricing.

Supply Chain Challenges:

Regulatory Variability: Differing approval standards and documentation requirements.
Raw Material Constraints: COVID-19 pandemic exposed vulnerabilities in sourcing APIs, prompting diversification.
Pricing Pressures: Increasing competition has led to tighter profit margins, requiring manufacturers to optimize production costs.

Regulatory Considerations & Market Access

Suppliers must navigate complex regulatory landscapes to sustain market access. Key considerations include:

Certification and Compliance: Ensuring API and finished product meet cGMP, DMF, CEP, and other relevant standards.
Patent Status: Although the original patent expired decades ago, ongoing patent litigations in specific markets influence supply routes.
Import Tariffs and Trade Agreements: These impact the cost structure for international suppliers.

Future Outlook

The global demand for Lasix remains strong, driven by the prevalence of conditions requiring diuretic therapy. Market expansion hinges on:

Regulatory approvals for biosimilar or novel formulations
Partnerships with emerging manufacturers
Enhanced supply chain resilience, especially for raw materials
Sustainable manufacturing practices to meet environmental and safety standards

Key Takeaways

The primary API suppliers for furosemide include Jiangsu Hengrui (China), Shandong Xinhua (China), and K+S (Germany), with these manufacturing hubs supporting global supply.
Established pharmaceutical giants like Pfizer, Teva, and Sandoz dominate finished product production, leveraging their extensive distribution networks.
Indian companies, notably Aurobindo, Dr. Reddy’s, and Cipla, play a pivotal role in regional markets, offering affordable Lasix formulations.
Regulatory compliance, certifications, and scalable manufacturing capacities are critical for supplier vetting.
Market dynamics are influenced by geopolitical factors, raw material sourcing, and evolving regulatory landscapes, affecting supply chain stability.

FAQs

1. Who are the leading manufacturers of furosemide API globally?
Leading API manufacturers include Jiangsu Hengrui (China), Shandong Xinhua (China), and K+S (Germany), with many others supplying for regional markets.

2. Are there significant regulatory barriers for importing Lasix?
Yes, different countries require compliance with local standards such as FDA, EMA, or CDSCO approvals, alongside certifications like CEP and DMF.

3. Which companies dominate the finished Lasix medication market?
Pfizer, Teva, Sandoz, and Indian generics firms like Cipla and Aurobindo are prominent in finished formulation manufacturing and distribution.

4. How has the COVID-19 pandemic impacted Lasix supply chains?
The pandemic disrupted raw material sourcing and manufacturing operations, leading to supply shortages and prompting diversification and localization efforts.

5. What are the trends influencing future Lasix supplier markets?
Increasing regional manufacturing, emerging market demand, tighter regulation, and focus on sustainable production are key trends shaping the supplier landscape.

Sources:

[1] U.S. Food and Drug Administration (FDA).
[2] European Medicines Agency (EMA).
[3] WHO - WHO Good Manufacturing Practices (GMP).
[4] GlobalData, Pharmaceutical Market Intelligence Reports.
[5] Company filings and industry reports.

Suppliers and packagers for lasix

lasix

Suppliers for the Pharmaceutical Drug: Lasix (Furosemide)