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Suppliers and packagers for PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
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PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Dr Reddys Labs Sa | PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | phenylephrine hydrochloride | SOLUTION;INTRAVENOUS | 216830 | NDA | Dr. Reddy's Laboratories Inc. | 43598-182-05 | 5 BAG in 1 CARTON (43598-182-05) / 250 mL in 1 BAG (43598-182-50) | 2025-07-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Phenylephrine Hydrochloride in 0.9% Sodium Chloride
Introduction
Phenylephrine hydrochloride in 0.9% sodium chloride solution is a pivotal pharmaceutical formulation used primarily as a vasopressor agent to elevate blood pressure during surgical procedures and in shock management. Its stability, efficacy, and rapid onset render it indispensable in clinical settings. As demand for this formulation surges, identifying reliable suppliers with consistent quality, regulatory compliance, and efficient supply chains becomes vital for pharmaceutical companies, hospitals, and distributors.
This analysis provides a comprehensive overview of key suppliers worldwide, highlighting their manufacturing capacities, regulatory standing, and strategic advantages.
Global Suppliers Overview
1. Pfizer Inc.
Overview: Pfizer is a leading global pharmaceutical manufacturer with extensive operations in sterile injectable products, including phenylephrine hydrochloride in saline solutions.
Capabilities: Pfizer produces phenylephrine formulations under strict Good Manufacturing Practice (GMP) standards, ensuring high purity and stability. The company’s facilities are certified by major regulatory bodies such as the FDA (USA), EMA (Europe), and WHO.
Market Presence: Pfizer supplies hospitals and distributors across North America, Europe, and emerging markets. Their robust R&D infrastructure assures ongoing innovation and quality assurance.
Regulatory Status: Approved for use in multiple countries, with comprehensive documentation supporting safety and efficacy.
2. Sagent Pharmaceuticals (parent company of Hikma)
Overview: Sagent specializes in sterile injectables, offering phenylephrine hydrochloride in 0.9% saline solutions.
Capabilities: Known for high-volume manufacturing and rapid turnaround, Sagent's facilities adhere to FDA, EU, and JP GMP standards. Their formulations meet USP and Ph. Eur. quality requirements.
Market Presence: Their products are widely distributed across North America, Asia, and Latin America, leveraging a strong logistics network.
Regulatory Status: Multiple NDA and ANDA approvals facilitate broad market access.
3. Hospira (a Pfizer company)
Overview: Hospira, now integrated with Pfizer, has historically been recognized for sterile drug manufacturing.
Capabilities: Their sterile injectables portfolio includes phenylephrine hydrochloride, emphasizing high-quality standards and reliable supply chains.
Market Presence: Dominant in North America with expanding footprints in Europe and Asia.
Regulatory Status: Meets FDA, EMA, and other major authorities' standards, with ongoing approvals for additional markets.
4. Anhui Biochem Group (China)
Overview: As a prominent Chinese pharmaceutical manufacturer, Anhui Biochem produces phenylephrine hydrochloride among other vasopressors.
Capabilities: The company offers bulk ingredients and finished products, focusing on cost-effective manufacturing and large-scale production capabilities.
Market Presence: Strong presence in Asia and expanding exports to Africa and South America.
Regulatory Status: Approved by Chinese authorities, with increasing efforts to attain WHO prequalification and CE marking for international markets.
5. AfriPharma Ltd.
Overview: An emerging supplier with focus on sterile injectables for African markets.
Capabilities: Provides phenylephrine hydrochloride in saline, emphasizing affordability and localized supply solutions.
Market Presence: Mainly active within African nations; partnerships with global logistics firms facilitate wider distribution.
Regulatory Status: Limited international approvals; compliance with local regulators is prioritized.
Key Factors in Supplier Selection
Regulatory Compliance and Certifications
Ensuring vendors hold relevant certifications (FDA, EMA, WHO Prequalification) is critical. These attest to the safety, quality, and consistency of phenylephrine hydrochloride solutions. Suppliers with robust documentation facilitate faster approval processes and reduce supply chain risks.
Manufacturing Capacity and Quality Assurance
Leaders in sterile injectable production invest heavily in manufacturing infrastructure, quality control, and process validation. Stability testing, endotoxin levels, and particulate matter assessments are essential parameters to evaluate.
Supply Chain Reliability
Global supply chain resilience, logistics capabilities, and inventory management determine the ability of suppliers to meet demand spikes, especially during pandemics or emergencies.
Cost and Market Position
While cost-effectiveness is vital, it must not compromise quality. Suppliers with optimized processes and economies of scale typically offer competitive pricing.
Geographical Reach
Suppliers with extensive distribution networks and compliance with country-specific regulations facilitate global access, especially crucial for multinational health organizations.
Emerging Trends and Considerations
- Manufacturing Geographical Diversification: The COVID-19 pandemic underscored risks in concentrated manufacturing hubs. Diversification among suppliers in North America, Europe, and Asia mitigates risks.
- Regulatory Harmonization Efforts: Increasing alignment among international standards streamlines approval processes, influencing supplier selection.
- Focus on Biosimilar and Generic Markets: Growing demand for cost-effective alternatives underscores the importance of suppliers who can produce at scale without compromising standards.
- Supply Chain Transparency: Digital tracking and certification verification ease due diligence efforts.
Conclusion
The landscape for phenylephrine hydrochloride in 0.9% sodium chloride solution reveals a blend of established multinational corporations and emerging regional players. Organizations prioritizing high-quality, regulatory-compliant suppliers—such as Pfizer, Sagent Pharmaceuticals, and Hospira—are well-positioned to meet global demands reliably. Meanwhile, Chinese suppliers like Anhui Biochem address capacity and cost considerations, especially for markets with constrained budgets.
Selecting the right supplier hinges on balancing regulatory adherence, manufacturing quality, supply reliability, and cost—factors critical to ensuring uninterrupted access to this essential medicine.
Key Takeaways
- Leading global suppliers for phenylephrine hydrochloride in saline include Pfizer, Sagent Pharmaceuticals, and Hospira, with extensive regulatory certifications and reliable supply chains.
- Chinese manufacturers like Anhui Biochem offer large-scale production at competitive prices but may face regulatory hurdles for international markets.
- Regulatory compliance (FDA, EMA, WHO) is essential, with certifications serving as a trust marker for quality assurance.
- Diversification of suppliers can mitigate supply risks and ensure continuous availability.
- Advances in manufacturing standards and logistics further support global distribution, especially for urgent medical needs.
FAQs
Q1: How can I verify the regulatory compliance of phenylephrine hydrochloride suppliers?
A1: Review their certifications from authorities like the FDA, EMA, and WHO, and request valid documentation of GMP adherence and batch testing results.
Q2: What factors influence the choice between multinational and regional suppliers?
A2: Consider regulatory approvals, cost, production capacity, logistical reliability, and compliance standards to determine suitability based on your operational needs.
Q3: Are there risks associated with sourcing phenylephrine from emerging markets?
A3: Potential risks include regulatory variability, quality assurance concerns, and supply chain disruptions. Due diligence and validation are essential.
Q4: How do supply chain disruptions impact pharmaceuticals like phenylephrine?
A4: Disruptions can lead to shortages, heightened costs, and compromised patient care. Maintaining diversified supplier bases and inventory buffers mitigates these risks.
Q5: What future trends will influence phenylephrine hydrochloride procurement?
A5: Increased regulatory harmonization, digital supply chain tracking, manufacturing diversification, and growing demand for cost-effective generics will shape procurement strategies.
Sources
[1] U.S. Food & Drug Administration (FDA). Pharmaceutical manufacturing standards.
[2] European Medicines Agency (EMA). Injectable product approvals.
[3] World Health Organization (WHO). Prequalification programs and standards.
[4] Sagent Pharmaceuticals corporate disclosures.
[5] Pfizer corporate publications and product portfolios.
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