Suppliers and packagers for levophed

levophed

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hospira	LEVOPHED	norepinephrine bitartrate	INJECTABLE;INJECTION	007513	NDA	Hospira, Inc.	0409-0161-10	10 VIAL, SINGLE-DOSE in 1 CARTON (0409-0161-10) / 4 mL in 1 VIAL, SINGLE-DOSE (0409-0161-01)	2024-03-11
Hospira	LEVOPHED	norepinephrine bitartrate	INJECTABLE;INJECTION	007513	NDA	Hospira, Inc.	0409-3375-04	10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3375-04) / 4 mL in 1 VIAL, SINGLE-DOSE (0409-3375-14)	2009-04-27
Hospira	LEVOPHED	norepinephrine bitartrate	INJECTABLE;INJECTION	007513	NDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1315-1	4 mL in 1 VIAL, SINGLE-DOSE (51662-1315-1)	2018-10-18
Hospira	LEVOPHED	norepinephrine bitartrate	INJECTABLE;INJECTION	007513	NDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1315-3	10 POUCH in 1 CASE (51662-1315-3) / 1 mL in 1 POUCH (51662-1315-2)	2018-10-18

Suppliers for the Pharmaceutical Drug: LEVOPHED

Last updated: August 1, 2025

Introduction

Levophed, the brand name for norepinephrine (also known as noradrenaline), is a critically important vasopressor used in emergency medicine and intensive care to manage hypotension and shock. Given its vital role in life-threatening conditions such as septic shock, cardiac arrest, and anesthesia-related hypotension, the supply chain for Levophed is tightly controlled and highly scrutinized. This article explores key suppliers, manufacturing dynamics, regulatory considerations, and the global landscape ensuring the consistent availability of this essential drug.

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Overview of Levophed as a Pharmaceutical Product

Levophed’s active pharmaceutical ingredient (API), norepinephrine, is synthesized through complex chemical processes and subjected to rigorous manufacturing standards. Its efficacy and safety depend on high-quality API sources and reliable formulation facilities. The drug is typically supplied in ampoules or vials, with packaging and distribution adhering to strict regulatory requirements from authorities such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and others globally.

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Major API Suppliers for Norepinephrine

The backbone of Levophed’s supply chain is the API providers. These suppliers produce the pharmaceutical-grade norepinephrine API utilized by generic and branded manufacturers worldwide.

1. Chinese API Manufacturers

China’s chemical and pharmaceutical industry dominates the supply of norepinephrine APIs, owing to cost efficiencies and large-scale production capabilities.

• Jiangsu Hengrui Medicine Co., Ltd.: A leading Chinese biotech company with a diversified portfolio, including APIs for cardiovascular drugs. Hengrui supplies norepinephrine API compliant with international standards, often exported globally.

• Shenzhen Third Pharmaceutical Factory: Known for producing bulk APIs, including vasopressors, with GMP (Good Manufacturing Practice) certifications. These APIs are exported to various countries, fulfilling OEM (Original Equipment Manufacturer) needs.

Regulatory considerations: Chinese API producers increasingly obtain regulatory approvals in key markets, but some face scrutiny due to quality assurance concerns. Companies that meet stringent GMP standards and have comprehensive regulatory documentation are preferred suppliers for global pharmaceutical companies.

2. Indian API Manufacturers

India’s pharmaceutical industry also plays a significant role in API supply for norepinephrine:

• Sun Pharmaceutical Industries Ltd.: An integrated pharmaceutical company with robust API production facilities that export APIs globally, including for vasopressor drugs.

• Lupin Limited: Known for high-volume production of cardiovascular APIs, including norepinephrine, with products compliant with US FDA and EMA standards.

Advantages: Indian suppliers benefit from established reputation, regulatory compliance (excluding some domestic concerns), and cost-effective manufacturing, making them key players in the global supply chain.

3. European and North American API Producers

Though less prominent in the API market for norepinephrine, certain European and North American companies produce high-purity APIs for specialized markets:

• Siegfried Holding AG (Switzerland): Offers custom synthesis services and supplies APIs for cardiovascular drugs, including norepinephrine, with rigorous quality standards.

• Fresenius Kabi (Germany): While mainly a finished drug manufacturer, supplies some API components or collaborates with API manufacturers to ensure supply chain integrity.

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Finished Dosage Form Manufacturers

Once API manufacturing is secured, pharmaceutical companies produce the finished Levophed product. Major manufacturers include:

4. Fresenius Kabi

A pioneer in the production and global distribution of Levophed. Fresenius Kabi owns the original patent rights for Levophed and is among the largest suppliers worldwide, ensuring distribution across hospitals, clinics, and emergency services.

5. Pfizer

While Pfizer’s leadership in vasopressors has diminished, historically, it was a key supplier. Current market presence is maintained through licensed manufacturing and distribution partnerships.

6. Teva Pharmaceuticals

Teva supplies generic norepinephrine products, sourcing from multiple API suppliers, with manufacturing facilities adhering to international quality standards and regulatory compliance.

7. Local Generics Manufacturers

Many regional players produce Levophed or equivalent norepinephrine formulations, especially in markets like India, China, and Latin America, where local manufacturing capacity meets domestic demand.

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Regulatory and Quality Assurance Factors

The criticality of consistent quality in vasopressors like Levophed necessitates rigorous oversight. Suppliers must meet GMP standards, and APIs must have validated analytical data confirming stability, potency, and absence of contaminants. Regulatory authorities frequently audit manufacturing facilities, and suppliers compliant with these standards are preferred for global distribution.

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Global Supply Chain Dynamics and Challenges

While the primary sources tend to be Chinese and Indian API manufacturers, recent geopolitical shifts, trade policies, and quality concerns have influenced the supply landscape:

• Geopolitical Tensions: Strained US-China relations, export controls, and trade tariffs impact API sourcing strategies.
• Supply Chain Disruptions: Pandemic-related lockdowns and manufacturing halts have temporarily disrupted supply, emphasizing the need for diversified sourcing.
• Quality and Compliance Risks: Variability in manufacturing standards necessitates thorough vetting to ensure APIs and finished goods meet pharmacopoeia specifications.

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Future Outlook and Trends

The future of Levophed supply hinges on:

• Diversification of API sources: To mitigate risks, pharmaceutical companies are expanding their supplier base beyond China and India.
• Vertical integration: Larger manufacturers are investing in their own API production to ensure quality control.
• Regulatory harmonization: Stricter global standards aim to improve API quality and traceability, enhancing supply chain resilience.

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Key Takeaways

• Primary API suppliers for Levophed originate predominantly from China and India, with established European and North American providers offering high-purity options.
• Regulatory compliance with GMP standards remains a non-negotiable criterion for suppliers engaged in global distribution.
• Diversification of supplier sources is increasing to address geopolitical and supply chain risks.
• Quality assurance and thorough validation processes are critical to maintaining the drug’s efficacy and safety.
• Strategic partnerships between finished drug manufacturers and API suppliers underpin the dependable supply of Levophed worldwide.

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FAQs

1. Who are the leading suppliers of norepinephrine API for Levophed?
Chinese companies like Jiangsu Hengrui Medicine and Indian firms such as Sun Pharma are among the top API providers, backed by international regulatory compliance.

2. How has supply chain disruption affected Levophed availability?
Pandemic disruptions and geopolitical tensions temporarily impacted API manufacturing and shipping, underscoring the need for diversified sourcing and contingency planning.

3. Are there quality concerns related to API suppliers?
Yes. The variability in manufacturing standards necessitates careful vetting of suppliers. Only those complying with GMP and holding relevant certifications are considered reliable.

4. What role do European and North American companies play in the Levophed supply chain?
They primarily supply high-purity APIs for specialized markets and often provide finished formulations, ensuring quality control and regulatory compliance.

5. Is there an ongoing shift towards local or regional API manufacturing for Levophed?
Yes. To reduce reliance on overseas suppliers and enhance security of supply, manufacturers are investing in regional API production facilities.

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References

1. U.S. Food and Drug Administration (FDA). Drug Approval and Manufacturing Requirements, 2022.
2. European Medicines Agency (EMA). Guidelines on Good Manufacturing Practice, 2022.
3. Kannan, R. & Kairamkonda, V. (2021). "Global API Supply Chains: Challenges and Opportunities." Journal of Pharmaceutical Sciences.
4. GlobalData. Pharmaceutical API Market Analysis; 2022.
5. Chinese Pharmaceutical Industry Association. API Production Standards and Compliance Reports, 2022.