Bulk Pharmaceutical API Sources for DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		H8502_SIGMA
Ambinter		BB_NC-1356
Calbiochem		4000
HDH Pharma		IN1467
NovoSeek		65340
MP Biomedicals		101580

Bulk Active Pharmaceutical Ingredient (API) Sources for: Dopamine Hydrochloride in Dextrose 5% in Plastic Container

Last updated: August 1, 2025

---

Introduction

Dopamine Hydrochloride, a critical catecholamine neurotransmitter and vasopressor agent, is extensively used in clinical settings to manage shock, heart failure, and hypotension. Its administration in Dextrose 5% (D5W) in plastic containers demands high-quality, regulatory-compliant bulk APIs from reliable sources. Ensuring a consistent supply of pharmaceutical-grade Dopamine Hydrochloride is vital for manufacturers to meet global standards and patient safety requirements.

---

Regulatory Landscape and Quality Standards

The procurement of Dopamine Hydrochloride APIs hinges on strict adherence to international standards such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and the Japanese Pharmacopoeia (JP). Additionally, regulations from agencies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada govern API manufacturing, testing, and distribution.

An API provider must demonstrate compliance with Good Manufacturing Practices (GMP), comprehensive quality assurance processes, stability data, and robust supply chain management. Advances in analytical technologies enable precise detection of impurities, ensuring API purity typically exceeds 99%.

---

Sources of Dopamine Hydrochloride API

1. Established International API Manufacturers

Leading pharmaceutical excipient and API manufacturers dominate the global Dopamine Hydrochloride supply chain. These companies leverage advanced synthesis methods, rigorous quality control, and extensive regulatory compliance to deliver consistent API quality.

a) Boehringer Ingelheim (Germany)
A global leader specializing in CNS and cardiovascular APIs, Boehringer Ingelheim produces Dopamine Hydrochloride with high purity standards, adhering to GMP and pharmacopeial monographs. Its extensive distribution network ensures reliable supply.

b) Novartis (Switzerland)
Novartis offers pharmaceutical-grade Dopamine Hydrochloride, meeting strict quality and regulatory standards. Its integration within global supply chains allows for responsive distribution aligned with manufacturing needs.

c) Harmonia Pharmaceutical (India)
A prominent API manufacturer in India, Harmonia specializes in synthesis and export of Dopamine Hydrochloride bulk APIs, compliant with international standards such as USP and EP, offering cost-effective options with stringent quality controls.

d) Anhui Biochem, Ltd. (China)
Specializing in synthetic chemical APIs, Anhui Biochem supplies Dopamine Hydrochloride in bulk to global pharmaceutical companies, maintaining high purity and rigorous testing standards.

---

2. Regional and Emerging API Suppliers

Several regional and emerging manufacturers provide Dopamine Hydrochloride API, often at competitive prices while maintaining quality standards.

a) Zhejiang Medicine Co., Ltd. (China)
This Chinese company is a major producer of pharmaceutical APIs, including Dopamine Hydrochloride, with certifications aligning to international GMP standards.

b) Sandoz (Novartis division, Switzerland/India)
Sandoz's generics division produces Dopamine Hydrochloride APIs for global markets, emphasizing compliance and consistency.

c) Sandoz GmbH (Austria)
Provides high-quality Dopamine Hydrochloride APIs with adherence to European regulations.

d) BioVectra (Canada)
An API and intermediate supplier known for custom synthesis and reliable quality controls, including Dopamine Hydrochloride.

---

Criteria for Selecting API Suppliers

Business professionals should prioritize the following when sourcing Dopamine Hydrochloride API:

• Regulatory Compliance: Confirm GMP, JDMF, or equivalent certifications.
• Quality Certifications: Ensure WHO-GMP, ISO 9001, USP, EP, or JP compliance.
• Purity and Impurity Profile: API purity should be ≥99%, with detailed impurity data.
• Supply Chain Stability: Evaluate production capacity, lead times, and contingency plans.
• Cost-Effectiveness: Balance quality and cost for sustainable procurement.
• Technical Support & Documentation: Access to Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and stability data.

---

Supply Chain Considerations

Complex logistics, customs, and regulatory approval processes influence API availability. Strategic partnerships with multiple vendors mitigate supply disruptions. Detailed validation and qualification of new suppliers are essential to ensure batch-to-batch consistency.

Special attention must be given to API stability within Dextrose 5% solution in plastic containers, which requires APIs with specifications compatible with formulation and packaging standards.

---

Top Manufacturers and Distributors

Company Name	Region	Certification	Key Strengths	Website
Boehringer Ingelheim	Germany	GMP, USP	High purity, global reach	Link
Novartis	Switzerland	GMP, USP, EP	Regulatory support	Link
Harmonia Pharmaceutical	India	GMP, USP	Cost-efficient, reliable supply	Link
Anhui Biochem	China	GMP, USP	Competitive pricing	Link
Zhejiang Medicine	China	GMP	Large-scale production	Link

---

Conclusion

Sourcing Dopamine Hydrochloride API for pharmaceutical preparations in Dextrose 5% in plastic containers requires meticulous selection from compliant, high-quality suppliers. Global leaders like Boehringer Ingelheim and Novartis offer premium APIs, while regional manufacturers such as Harmonia Pharmaceutical and Anhui Biochem provide cost-effective alternatives. Maintaining supply chain stability, regulatory adherence, and rigorous quality screening underpin successful procurement strategies.

---

Key Takeaways

• Prioritize APIs with ISO, GMP, and pharmacopeial compliance for safety and efficacy.
• Engage with established global manufacturers for consistent quality.
• Evaluate suppliers on impurity profiles, stability, and documentation.
• Develop diversified supply chains to mitigate risks of disruption.
• Ensure API compatibility with formulation and packaging specifications.

---

FAQs

1. What are the primary regulatory standards for Dopamine Hydrochloride API?
Major standards include the USP, EP, and JP monographs, with GMP compliance mandated by agencies like the FDA and EMA for manufacturing.

2. How does API purity impact formulation and patient safety?
Higher purity reduces impurities that could cause adverse effects or interfere with drug efficacy, ensuring safer, more effective formulations.

3. Can regional manufacturers meet international quality standards?
Yes. Many regional suppliers acquire GMP certifications and adhere to global standards, making them suitable for international pharmaceutical manufacturing.

4. What are the typical lead times for sourcing Dopamine Hydrochloride API?
Lead times vary based on supplier capability, quantity ordered, and logistical factors but generally range from 4 to 12 weeks.

5. How does formulation in plastic containers affect API stability requirements?
Plastic containers can interact with certain APIs; suppliers should provide stability data confirming API compatibility and stability within the D5W solution.

---

Sources

[1] U.S. Pharmacopeia. Dopamine Hydrochloride monograph.
[2] European Pharmacopoeia. Dopamine Hydrochloride standards.
[3] FDA Regulations on API manufacturing.
[4] International API supplier directories and company certifications.