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Suppliers and packagers for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
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NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Baxter Hlthcare Corp | NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE | norepinephrine bitartrate | SOLUTION;INTRAVENOUS | 214313 | NDA | Baxter Healthcare Corporation | 0338-0108-20 | 20 CONTAINER in 1 CARTON (0338-0108-20) / 250 mL in 1 CONTAINER | 2021-01-15 |
| Baxter Hlthcare Corp | NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE | norepinephrine bitartrate | SOLUTION;INTRAVENOUS | 214313 | NDA | Baxter Healthcare Corporation | 0338-0112-20 | 20 BAG in 1 CARTON (0338-0112-20) / 250 mL in 1 BAG | 2021-01-15 |
| Baxter Hlthcare Corp | NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE | norepinephrine bitartrate | SOLUTION;INTRAVENOUS | 214313 | NDA | Baxter Healthcare Corporation | 0338-0116-20 | 20 BAG in 1 CARTON (0338-0116-20) / 250 mL in 1 BAG | 2023-11-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for Norepinephrine Bitartrate in 5% Dextrose
Introduction
Norepinephrine Bitartrate in 5% Dextrose is a critical vasoactive agent used predominantly in acute care settings for hemodynamic stabilization. Its primary applications include the management of hypotension and shock, especially in intensive care units. The pharmaceutical industry supplies this formulation globally through a network of manufacturers and authorized distributors. For healthcare providers and procurement agencies, identifying reputable suppliers with quality assurance, regulatory compliance, and reliable delivery is vital. This article offers an in-depth review of key suppliers for Norepinephrine Bitartrate in 5% Dextrose, analyzing their market presence, manufacturing capabilities, and regulatory status.
Understanding the Formulation: Norepinephrine Bitartrate in 5% Dextrose
Norepinephrine Bitartrate is a potent adrenergic agonist that constricts blood vessels, elevating blood pressure. Its formulation in 5% Dextrose (Dextrose 5%) solutions provides a stable medium for intravenous administration. Due to the critical nature of this drug, suppliers must adhere to stringent Good Manufacturing Practices (GMP), ensure sterility, and maintain proper stability during storage and distribution.
Market Overview and Regulatory Landscape
The global demand for Norepinephrine Bitartrate in 5% Dextrose is concentrated primarily in the United States, Europe, and emerging markets such as Asia-Pacific. Regulatory bodies—including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and others—require rigorous approval processes, including comprehensive clinical and manufacturing data before licensing a product for sale. Suppliers maintaining approval from these agencies have a competitive advantage, ensuring quality and safety.
Key Suppliers and Manufacturers
1. Pfizer Inc.
Market Presence: Pfizer is one of the world’s leading pharmaceutical companies, holding a significant share of the critical care drug market, including Norepinephrine Bitartrate formulations.
Product Portfolio: Pfizer’s Norepinephrine Bitartrate and other vasopressors are marketed under the brand name Levophed in various formulations, including 4 mg/4 mL (1 mg/mL) vials diluted in 5% Dextrose.
Manufacturing and Quality: Pfizer’s manufacturing facilities are GMP-certified, with rigorous quality assurance processes. Their products are approved by regulatory agencies, ensuring compliance with international standards.
Distribution and Availability: Pfizer’s extensive global distribution network facilitates widespread availability, essential in acute care settings worldwide.
2. Fresenius Kabi
Market Presence: A prominent player specializing in infusion therapies and critical care solutions, Fresenius Kabi supplies Norepinephrine Bitartrate in multiple concentrations.
Product Portfolio: Their formulations typically include 8 mg/250 mL or 4 mg/250 mL vials, diluted for intravenous infusion in dextrose solutions, with strict compliance to pharmacopoeial standards.
Manufacturing and Quality: Fresenius Kabi emphasizes sterile manufacturing environments adhering to EU and FDA standards, with a focus on stability and bioequivalence.
Distribution and Availability: Their products are available globally, especially in Europe, Asia, and Latin America, supported by robust supply chain logistics.
3. Sagent Pharmaceuticals (part of Hikma Pharmaceuticals)
Market Presence: Sagent Pharmaceuticals, now integrated within Hikma, specializes in injectable pharmaceuticals, including vasopressors.
Product Portfolio: They provide Norepinephrine Bitartrate in 4 mg/4 mL vials, compatible with 5% Dextrose infusion, with a focus on high-quality sterile preparations.
Manufacturing and Quality: Their facilities are GMP-certified, with a focus on sterile injectable manufacturing, rigorous testing, and stability confirmation.
Distribution and Availability: Sagent’s products are accessible across North America, with expanding footprints into emerging markets.
4. Hikma Pharmaceuticals
Market Presence: Hikma, a global name in generic and branded pharmaceuticals, offers Norepinephrine Bitartrate in injectable formulations.
Product Portfolio: Their vasopressor formulations include compatible concentrations for infusion in Dextrose solutions, meeting various regulatory standards.
Manufacturing and Quality: Hikma invests heavily in quality assurance, operating GMP-compliant facilities, with a reputation for manufacturing consistency.
Distribution and Availability: Widely distributed in the Middle East, Europe, and North America, Hikma emphasizes reliable supply chains for emergency medications.
5. Martinsried-Based Hovione
Market Presence: While primarily a contract development and manufacturing organization (CDMO), Hovione supplies excipients and active pharmaceutical ingredients (APIs).
Potential Role: They supply NR dyes, excipients, and APIs, but also partner with pharmaceutical firms for custom production of norepinephrine APIs.
Regulatory and Quality: Hovione maintains an excellent reputation for GMP compliance, especially for sensitive products like vasopressors.
Regulatory and Quality Assurance Considerations
For procurement, verifying that suppliers meet regulatory approval—such as FDA approval or EMA authorization—is crucial. Only products compliant with pharmacopeial standards (USP, EP, JP) ensure safety, efficacy, and stability. Besides, suppliers should adhere to strict sterility protocols and provide clear Certificates of Analysis (CoA), stability data, and batch traceability.
Emerging Markets and Local Manufacturers
In emerging markets, several local manufacturers produce Norepinephrine Bitartrate in 5% Dextrose, often under licensing agreements or through generic licensing. Some notable regional suppliers include:
- Shanxi Yuncheng Medical Equipment Co., Ltd. (China)
- Sun Pharmaceuticals (India)
- Aventis Pharma (Brazil)
Their products are often approved locally by respective regulatory agencies and might offer a cost-effective alternative where supply chain constraints exist.
Supply Chain and Market Dynamics
The global supply of Norepinephrine Bitartrate in 5% Dextrose is influenced by manufacturing capacity, raw material availability, and geopolitical factors. The recent surge in demand during COVID-19 highlighted supply chain vulnerabilities. Suppliers with diversified manufacturing sites, comprehensive quality assurance, and strategic stockpiles are better positioned to ensure continuous supply.
Conclusion
The procurement of Norepinephrine Bitartrate in 5% Dextrose necessitates careful selection of reputable suppliers with proven quality, regulatory clearance, and reliable distribution networks. Leading players such as Pfizer, Fresenius Kabi, Hikma, and Sagent Pharmaceuticals dominate the global market, offering products aligned with international standards. Additionally, regional manufacturers fill vital gaps in emerging markets.
Healthcare providers should prioritize suppliers with demonstrated GMP compliance, robust logistics capabilities, and regulatory approvals from pertinent agencies. Strategic partnerships with these suppliers can mitigate supply risks, ensuring uninterrupted access to this critical medication.
Key Takeaways
- Major global suppliers include Pfizer, Fresenius Kabi, Hikma, and Sagent Pharmaceuticals, all of whom maintain GMP-certified manufacturing and broad regulatory approvals.
- Regulatory compliance is paramount—verify approval status (FDA, EMA, local agencies) and adherence to pharmacopeial standards for safety and efficacy.
- Supply chain resilience depends on diversified manufacturing and strategic inventory management, especially highlighted during pandemic-related disruptions.
- Regional manufacturers can be valuable alternatives in emerging markets, provided their products meet quality standards and regulatory requirements.
- Due diligence in supplier assessments—including transparency in Certificates of Analysis, stability data, and batch tracing—reduces procurement risks.
FAQs
1. Are generic versions of Norepinephrine Bitartrate in 5% Dextrose available globally?
Yes, multiple generic manufacturers supply Norepinephrine Bitartrate in various concentrations compatible with 5% Dextrose, often approved by local regulators and compliant with pharmacopeial standards.
2. What are the key factors to consider when selecting a supplier for acute care medications?
Regulatory approval, GMP compliance, product stability, batch traceability, supply reliability, and logistics capabilities are critical considerations.
3. How does the regulatory landscape influence supplier selection?
Regulatory approval from authorities like the FDA or EMA assures product safety and efficacy, making products from approved suppliers more trustworthy and reducing compliance risks.
4. Can regional or local suppliers meet international safety standards for Norepinephrine Bitartrate?
They can, provided they adhere to GMP standards and obtain necessary regulatory approvals; however, verification is essential before procurement.
5. What are the risks of supply chain disruptions for Norepinephrine Bitartrate?
Raw material shortages, manufacturing disruptions, geopolitical issues, and global demand surges can cause shortages, emphasizing the need for diversified supplier sources and inventory management.
References
[1] U.S. Food and Drug Administration. Approved Drug Products with Therapeutic Equivalence Evaluations.
[2] European Medicines Agency. Summary of Product Characteristics for Norepinephrine Bitartrate.
[3] Pfizer Inc. Product Information Documents.
[4] Fresenius Kabi. Product Literature and GMP Certification.
[5] Hikma Pharmaceuticals. Regulatory Approvals and Manufacturing Standards.
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