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Suppliers and packagers for generic pharmaceutical drug: dopamine hydrochloride
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dopamine 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 |
|---|---|---|---|---|---|---|---|---|---|
| Hikma Intl Pharms | DOPAMINE HYDROCHLORIDE | dopamine hydrochloride | INJECTABLE;INJECTION | 207707 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9252-25 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0143-9252-25) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9252-01) | 2018-04-11 |
| Hikma Intl Pharms | DOPAMINE HYDROCHLORIDE | dopamine hydrochloride | INJECTABLE;INJECTION | 207707 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9253-25 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0143-9253-25) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9253-01) | 2018-04-11 |
| Hikma Intl Pharms | DOPAMINE HYDROCHLORIDE | dopamine hydrochloride | INJECTABLE;INJECTION | 207707 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9254-25 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0143-9254-25) / 10 mL in 1 VIAL, SINGLE-DOSE (0143-9254-01) | 2018-04-11 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Dopamine Hydrochloride
Introduction
Dopamine Hydrochloride is a cornerstone pharmaceutical agent used primarily in acute settings to manage cardiovascular shock, heart failure, and to support blood pressure stability during surgical procedures. Its clinical efficacy hinges on reliable sourcing from established suppliers capable of meeting stringent manufacturing standards and supply demands. This article delves into the global landscape of suppliers for Dopamine Hydrochloride, examining key manufacturers, market dynamics, regulatory considerations, and supply chain strategies vital for pharmaceutical businesses.
Market Overview and Demand Drivers
Dopamine Hydrochloride, classified as a vasoactive adrenergic agonist, commands a significant share in emergency and intensive care units worldwide. The demand stems from hospitals, compounding pharmacies, and medical distributors, especially within regions emphasizing critical care infrastructure. The increasing prevalence of cardiovascular emergencies, expanding ICU capacities, and ongoing medical reforms propel the need for a steady, high-quality supply.
The global market for Dopamine Hydrochloride is projected to grow at a compound annual growth rate (CAGR) of approximately 4-5% over the next five years, driven by expanding healthcare access and technological advancements in drug manufacturing. Ensuring supply chain resilience becomes imperative as clinical reliance intensifies.
Key Suppliers in the Global Market
1. Pfizer Inc.
Pfizer remains a prominent supplier, offering Dopamine Hydrochloride through their extensive portfolio of injectable medicines. Known for rigorous quality standards, Pfizer’s manufacturing units are FDA- and EMA-approved, ensuring global compliance. Their supply chain enables distribution across North America, Europe, and emerging markets.
2. Hospira (a Pfizer company)
Specializing in injectable drugs, Hospira holds a significant market share, especially in North America. Their manufacturing facilities are designed for sterile, large-volume parenteral production, and they follow rigorous GMP protocols. Hospira’s supply network emphasizes efficiency, ensuring consistent drug availability for critical care needs.
3. Fresenius Kabi
A leading European-based pharmaceutical and medical device company, Fresenius Kabi supplies Dopamine Hydrochloride across Europe, Asia, and Australasia. Their product portfolio includes a broad range of infusion solutions, with manufacturing standards aligned with global regulatory requirements. The company emphasizes sustainable and high-quality sourcing.
4. Sun Pharmaceutical Industries Ltd.
As Asia’s largest pharmaceutical manufacturer, Sun Pharma offers Dopamine Hydrochloride primarily to the Indian subcontinent, Southeast Asia, and emerging markets. They possess GMP-compliant manufacturing facilities and a growing international footprint. Their competitive pricing supports accessibility in cost-sensitive regions.
5. Teva Pharmaceutical Industries Ltd.
Based in Israel, Teva supplies injectable medications across Europe, North America, and Latin America. Their robust supply chain and focus on quality control help maintain consistent drug availability, including Dopamine Hydrochloride.
6. Local and Regional Manufacturers
Numerous regional players manufacture Dopamine Hydrochloride to serve localized markets. These companies often operate under strict regulatory oversight, such as the Indian Drug Controller General or the Chinese SFDA, ensuring compliance with international standards for quality assurance.
Regulatory and Quality Considerations
Supplying Dopamine Hydrochloride requires compliance with rigorous regulatory standards given its critical care application. Suppliers must adhere to Good Manufacturing Practices (GMP), ISO certifications, and meet pharmacopoeial specifications outlined by the USP, BP, or EP.
Regulatory agencies such as the FDA, EMA, and WHO conduct periodic audits, emphasizing safety, purity, and potency. Manufacturers must also ensure stability under various storage conditions, particularly since Dopamine Hydrochloride is sensitive to oxidation and hydrolysis.
For international trade, approval documentation, Certificate of Analysis (CoA), and batch release certificates are mandatory. Buyers should verify supplier certification to guarantee regulatory compliance, particularly when sourcing from emerging markets.
Supply Chain and Procurement Strategies
Ensuring a stable supply of Dopamine Hydrochloride involves multiple strategic considerations:
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Supplier Qualification: Conduct thorough audits to verify regulatory compliance, manufacturing capacity, and quality control systems.
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Diversification: Avoid over-reliance on a single supplier by establishing relationships with multiple vetted manufacturers across regions.
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Inventory Management: Implement just-in-time (JIT) inventory or safety stock policies based on usage forecasts to mitigate disruptions.
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Regulatory Vigilance: Monitor changes in regulatory policies and adjust procurement procedures accordingly to maintain compliance and uninterrupted supply.
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Partnerships and Contracts: Engage in long-term purchase agreements with clearly defined quality standards and contingency provisions.
Emerging Trends and Future Outlook
The pharmaceutical industry is witnessing advances in manufacturing technology, including continuous manufacturing and process automation, which enhance product quality and supply reliability for Dopamine Hydrochloride. Increasing focus on biosimilars and generic formulations might also influence supplier dynamics, fostering competition and potentially reducing pricing.
Additionally, the ongoing efforts to improve global supply chain transparency and traceability—via serialization and digital tracking—are expected to bolster confidence in procurement. Emerging markets are witnessing expansion of local manufacturing capabilities, which could influence supply sources over the next decade.
Furthermore, regulatory harmonization efforts, such as those championed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), aim to streamline approval processes, impacting supplier registration and product registration timelines worldwide.
Conclusion
The procurement landscape for Dopamine Hydrochloride is characterized by a handful of global players with established GMP-compliant manufacturing capacities, complemented by regional manufacturers serving localized markets. Major pharmaceutical companies like Pfizer, Hospira, Fresenius Kabi, Sun Pharma, and Teva dominate the supply chain, supported by regional and emerging market producers.
Stability in supply hinges on comprehensive qualification processes, regulatory adherence, and strategic sourcing approaches. As demand persists and intensifies, supply chain resilience, technological innovation, and regulatory harmonization will be crucial elements for pharmaceutical entities reliant on this critical medication.
Key Takeaways
- Leading global suppliers include Pfizer, Hospira, Fresenius Kabi, Sun Pharma, and Teva, each maintaining GMP compliance and extensive distribution networks.
- Regulatory adherence (GMP, ISO, pharmacopoeial standards) is paramount for supplier qualification.
- Diversification and proactive supply chain management mitigate risks associated with disruptions.
- Technological advances and regulatory harmonization foster improved supply reliability and cost efficiency.
- Regional manufacturers supplement global supply chains, especially in emerging markets, enhancing access and affordability.
Frequently Asked Questions
Q1: What are the primary regulatory considerations when sourcing Dopamine Hydrochloride?
A1: Suppliers must comply with GMP standards, provide Certificates of Analysis (CoA), and adhere to pharmacopeial specifications (USP, BP, EP). Regulatory approvals from agencies like the FDA, EMA, and WHO ensure product safety, efficacy, and quality.
Q2: How can hospitals ensure the quality of Dopamine Hydrochloride from regional manufacturers?
A2: Hospitals should perform supplier qualification audits, verify certifications, review batch documentation, and ensure proper storage conditions to maintain drug integrity.
Q3: What factors influence the pricing of Dopamine Hydrochloride across regions?
A3: Pricing is affected by manufacturing costs, regulatory compliance, regional tariffs, market competition, and supply-demand dynamics. Cost-effective regional producers can offer lower prices than global players.
Q4: How is supply chain risk managed for Dopamine Hydrochloride?
A4: Strategies include supplier diversification, maintaining safety stocks, establishing strong contractual agreements, and monitoring geopolitical or regulatory changes that could impact production or distribution.
Q5: What are the emerging trends likely to impact Dopamine Hydrochloride suppliers?
A5: Trends include technological innovations in manufacturing, increased regulatory harmonization, market expansion in emerging regions, and the development of biosimilar alternatives, potentially affecting supplier competition and pricing.
Sources
- Market Research Future. (2022). Global Dopamine Market Analysis.
- United States Pharmacopeia. (2021). Dopamine Hydrochloride Monograph.
- European Pharmacopoeia. (2022). Standards for Injectable Dopamine.
- FDA Drugs Database. (2023). Approved Drugs List.
- Industry Reports. (2022). Global Critical Care Pharmaceuticals Market Outlook.
This analysis provides a comprehensive overview designed for decision-makers in the pharmaceutical supply chain seeking reliable sourcing options for Dopamine Hydrochloride.
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