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Suppliers and packagers for generic pharmaceutical drug: PHENYLEPHRINE HYDROCHLORIDE
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PHENYLEPHRINE HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Alcon | PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 207926 | NDA | Alcon Laboratories, Inc. | 0065-0343-02 | 1 BOTTLE, DROPPER in 1 CARTON (0065-0343-02) / 5 mL in 1 BOTTLE, DROPPER | 2015-01-15 |
| Alcon | PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 207926 | NDA | Alcon Laboratories, Inc. | 0065-0349-04 | 1 BOTTLE, DROPPER in 1 CARTON (0065-0349-04) / 15 mL in 1 BOTTLE, DROPPER | 2015-01-15 |
| Alcon | PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 207926 | NDA | Alcon Laboratories, Inc. | 0065-0349-05 | 1 BOTTLE, DROPPER in 1 CARTON (0065-0349-05) / 2 mL in 1 BOTTLE, DROPPER | 2015-01-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Phenylephrine Hydrochloride
Introduction
Phenylephrine hydrochloride is a widely used sympathomimetic agent primarily employed as a nasal decongestant, vasoconstrictor, and adjunct in anesthesia. Its efficacy hinges on reliable sourcing from reputable suppliers that adhere to stringent quality standards. This article examines the landscape of global suppliers for phenylephrine hydrochloride, detailing key manufacturers, geographic distributions, supply chain considerations, and regulatory implications critical for pharmaceutical companies, distributors, and healthcare providers seeking dependable procurement channels.
Overview of Phenylephrine Hydrochloride
Phenylephrine hydrochloride is a semi-synthetic adrenergic agonist with vasoconstrictive properties. Its chemical formula is C9H13NO2·HCl, and it is commonly available as a sterile, injectable solution, or as part of compounded nasal sprays and oral formulations (e.g., tablets, liquids). Its widespread medical use, especially in over-the-counter decongestant products, ensures a stable demand that underscores the importance of secure sourcing from high-quality suppliers.
Global Suppliers of Phenylephrine Hydrochloride
The supply landscape features a mix of major pharmaceutical ingredient (API) manufacturers, contract manufacturing organizations (CMOs), and regional suppliers. The following delineates primary suppliers based on geographic distribution and market presence.
North American Suppliers
1. BOEHRINGER INGELHEIM (Germany/USA)
While based in Germany, Boehringer Ingelheim operates manufacturing facilities in the USA that produce phenylephrine hydrochloride APIs, adhering to Good Manufacturing Practices (GMP). The company supplies to pharmaceutical firms and OTC market players, emphasizing high purity and batch-to-batch consistency [1].
2. AKORN, INC.
Headquartered in the USA, Akorn supplies compounded pharmaceuticals and APIs, including phenylephrine hydrochloride. Their manufacturing facilities are FDA-approved, ensuring regulatory compliance suitable for marketed formulations [2].
3. Pfizer Inc.
Though primarily known for formulation, Pfizer’s API manufacturing units produce phenylephrine hydrochloride for internal and contractual supply, maintaining high regulatory standards.
European Suppliers
4. Evonik Industries AG (Germany)
Evonik produces chemical intermediates and active pharmaceutical ingredients, including phenylephrine hydrochloride, primarily serving the European market, with GMP certification and stringent quality controls [3].
5. Merck KGaA (Germany)
Merck supplies a broad range of APIs, including phenylephrine hydrochloride, to global markets. Their manufacturing facilities comply with international regulatory standards, ensuring high purity APIs.
Asian Suppliers
6. Zhejiang Hangzhou Wego Pharmaceutical Co., Ltd. (China)
A prominent Chinese API manufacturer, Wego offers phenylephrine hydrochloride with competitive pricing, backed by ISO and GMP certifications. Their products are exported worldwide, predominantly to emerging markets [4].
7. Jiangsu Hengrui Medicine Co., Ltd. (China)
Hengrui is a leading Chinese pharmaceutical enterprise with API manufacturing capabilities, including phenylephrine derivatives, serving global clients with quality standards aligned with international markets [5].
8. Changzhou Siyao Pharmaceutical Co., Ltd. (China)
Specializing in various adrenergic agents, Siyao supplies phenylephrine hydrochloride with focus on affordability and compliance with international standards.
Indian Suppliers
9. Sun Pharma Advanced Research Company Ltd. (India)
Sun Pharma, one of India's top pharma companies, manufactures phenylephrine hydrochloride APIs, emphasizing high-quality production and regulatory approvals suitable for global export.
10. Aarti Industries Ltd.
Aarti Industries produces phenylephrine hydrochloride, serving diverse markets with a focus on reliable supply and GMP adherence.
Other Notable Suppliers
- Synergy Pharmaceuticals (India)
Focuses on contract manufacturing of phenylephrine hydrochloride for global pharmaceutical companies, compliant with international regulatory standards. - Glenmark Pharmaceuticals (India)
Engaged in API production, including adrenergic agents like phenylephrine, with certifications for global markets.
Supply Chain Considerations
The procurement of phenylephrine hydrochloride involves assessing several critical factors:
- Quality Certifications: Ensure suppliers hold GMP, ISO 9001, and other relevant certifications to guarantee API purity and safety.
- Regulatory Compliance: Suppliers must conform to FDA, EMA, or equivalent agencies depending on the target market.
- Manufacturing Capacity: Ability to meet demand fluctuations, especially during health crises like respiratory illness outbreaks.
- Traceability & Transparency: Supply chain transparency aids in compliance documentation and quality assurance.
- Pricing & Lead Times: Competitive pricing without compromising quality, coupled with reliable lead times, remain vital.
Regulatory and Quality Standards
The quality of phenylephrine hydrochloride hinges on rigorous quality control testing, including assays for potency, impurities, residual solvents, and microbial contamination. Suppliers compliant with ICH guidelines and capable of providing batch documentation and stability data are preferred. Any disruption in supply chain quality standards can jeopardize formulations and patient safety, underscoring the importance of selecting suppliers with high compliance credentials.
Emerging Trends and Market Dynamics
The increasing demand driven by respiratory treatments, especially in the context of global health emergencies, has accentuated the need for diversified sourcing. Companies are shifting toward multiple suppliers to mitigate risks associated with supply disruptions, geopolitical issues, and regulatory hurdles. Additionally, the rise of regional API manufacturing hubs in Asia and Eastern Europe diversifies the supply landscape, although it necessitates thorough due diligence regarding quality assurance.
Conclusion
The global supply chain for phenylephrine hydrochloride is robust, supported by established manufacturers primarily in North America, Europe, and Asia. Leading suppliers such as Boehringer Ingelheim, Evonik, Wego Pharmaceutical, and Sun Pharma are recognized for their quality and compliance standards. Contract manufacturers and regional suppliers also play vital roles, especially in addressing regional market demands and cost considerations.
Ensuring a secure, high-quality supply involves scrutinizing manufacturer credentials, compliance certifications, and capacity to meet regulatory requirements. With the global market evolving and demands rising, continuous supplier evaluation and diversification are essential strategies for pharmaceutical companies and healthcare providers.
Key Takeaways
- The phenylephrine hydrochloride supply chain is anchored by reputable global manufacturers adhering to strict quality standards.
- North American and European suppliers emphasize regulatory compliance, quality assurance, and stability, while Asian firms often offer competitive pricing.
- Supply chain resilience demands diversification of suppliers and rigorous supplier qualification processes.
- Regulatory compliance and traceability are critical; suppliers should provide certifications, batch documentation, and stability data.
- Market dynamics favor increased regional production and contract manufacturing, necessitating ongoing diligence around quality and compliance.
FAQs
1. What are the primary regions manufacturing phenylephrine hydrochloride?
Major manufacturing regions include North America (USA and Canada), Europe (Germany, the UK), and Asia (China, India), with China and India being prominent due to cost advantages and expanding capacity.
2. How can I verify the quality of phenylephrine hydrochloride from a supplier?
Verify certifications such as GMP, ISO, and pharmacopoeial compliance, request batch test reports, stability data, and ensure supplier transparency about manufacturing processes.
3. Are there specific regulatory challenges associated with sourcing phenylephrine hydrochloride?
Regional regulations may require documentation for GMP compliance, import licenses, and registration depending on the country. Ensuring suppliers meet these standards minimizes regulatory hurdles.
4. What role do contract manufacturing organizations play in phenylephrine hydrochloride supply?
Contract manufacturers expand capacity, offer cost efficiency, and facilitate diversification of supply sources, especially during supply chain disruptions.
5. What risks should be considered when sourcing phenylephrine hydrochloride from emerging markets?
Risks include variability in quality standards, regulatory differences, supply stability, and traceability issues. Due diligence and supplier audits are key mitigants.
Sources
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