Suppliers and packagers for generic pharmaceutical drug: DOBUTAMINE HYDROCHLORIDE

DOBUTAMINE 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	DOBUTAMINE HYDROCHLORIDE	dobutamine hydrochloride	INJECTABLE;INJECTION	074277	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9141-10	10 VIAL in 1 CARTON (0143-9141-10) / 20 mL in 1 VIAL	2023-05-03
Hospira	DOBUTAMINE HYDROCHLORIDE	dobutamine hydrochloride	INJECTABLE;INJECTION	074086	ANDA	Hospira, Inc.	0409-2344-88	10 VIAL, SINGLE-DOSE in 1 TRAY (0409-2344-88) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-2344-68)	2005-04-30
Hospira	DOBUTAMINE HYDROCHLORIDE	dobutamine hydrochloride	INJECTABLE;INJECTION	074086	ANDA	Hospira, Inc.	0409-2344-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0409-2344-01) / 20 mL in 1 VIAL, SINGLE-DOSE	2005-04-30

Suppliers for the Pharmaceutical Drug: Dobutamine Hydrochloride

Last updated: July 29, 2025

Introduction

Dobutamine hydrochloride is a widely used inotropic agent primarily indicated for acute heart failure management and cardiogenic shock. Its capacity to enhance cardiac output by stimulating β1-adrenergic receptors has cemented its role in intensive care settings globally. Ensuring a reliable supply chain of high-quality dobutamine hydrochloride is critical for healthcare providers, pharmaceutical manufacturers, and distributors alike. This report examines the major suppliers, manufacturing landscape, and sourcing considerations for dobutamine hydrochloride.

---

Overview of Dobutamine Hydrochloride

Dobutamine hydrochloride is synthesized through complex chemical processes that require strict adherence to pharmaceutical standards. Its production involves the derivation of phenylethanolamine compounds, culminating in a highly purified hydrochloride form. Because of its sensitive nature, especially concerning stability during storage and handling, suppliers must comply with stringent pharmacopoeial standards such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and others.

---

Major Global Suppliers

1. Pfizer Inc.

As the original developer of dobutamine, Pfizer remains a dominant supplier globally. Their formulations are recognized for consistent quality and reliability. Pfizer's supply network spans North America, Europe, and emerging markets, supported by robust manufacturing facilities and rigorous quality control procedures. Due to patent expirations, Pfizer's formulation is now available as a generic, bolstered by other manufacturers.

2. Hospira (A Pfizer Company)

Hospira, now integrated within Pfizer’s global operations, specializes in sterile injectable medications, including dobutamine hydrochloride. They are known for their extensive portfolio of injectable generics, adhering to Good Manufacturing Practices (GMP) and ensuring high purity standards.

3. Jiangsu Hengrui Medicine Co., Ltd.

This Chinese pharmaceutical manufacturer is among the notable global producers of dobutamine hydrochloride. Hengrui has invested heavily in API development and manufacturing, aligning with international standards. Its products are distributed extensively across Asia, with increasing penetration into European and North American markets through partnerships and licensing arrangements.

4. Teva Pharmaceutical Industries

A key global generic manufacturer, Teva supplies pharmaceutical-grade dobutamine hydrochloride used worldwide. Their manufacturing facilities adhere to the highest quality standards, ensuring compliance with regulatory agencies such as the FDA and EMA.

5. Sandoz / Novartis

Sandoz, the generics division of Novartis, produces dobutamine hydrochloride for various markets, emphasizing affordability without compromising quality. Their extensive distribution channels facilitate the global availability of the drug.

6. Other Notable Suppliers

• Jiangsu Nhwa Pharmaceutical Co., Ltd. – A prominent Chinese API producer, contributing significant quantities.
• Bayer AG – Historically involved in cardiovascular drugs; while currently more focused on newer treatments, Bayer has been involved in manufacturing for legacy formulations.

---

Key Manufacturing and Supply Considerations

• Compliance with Regulatory Standards: Suppliers must meet regulatory standards such as GMP, with many markets requiring FDA, EMA, or separate country-specific approvals.

• Quality Certification and Verification: Suppliers with certifications like ISO 9001 or ISO 13485 are preferred for ensuring consistent quality and supply reliability.

• API versus Finished Product: Some suppliers focus solely on active pharmaceutical ingredient (API) production; others may supply finished injectable formulations. Procurement strategies depend on organizational capacity for formulation and sterility testing.

• Supply Chain Stability: Given the critical nature of dobutamine in acute settings, suppliers offering consistent, on-time delivery and supply chain transparency are prioritized.

• Price and Market Dynamics: Competitive pricing, especially from suppliers in emerging markets, influences procurement decisions, balanced against quality and regulatory compliance.

---

Regional Supplier Trends

North America: Dominated by Pfizer and Hospira, with stringent regulatory oversight ensuring high-quality supplies.

Europe: Multiple suppliers including Sandoz and Teva, along with local manufacturers adhering to EMA standards.

Asia-Pacific: Growing number of API manufacturers including Jiangsu Hengrui and Jiangsu Nhwa, driven by increasing demand and cost considerations.

Emerging Markets: Local suppliers are gaining prominence, but they often face hurdles related to regulatory approvals and quality assurance.

---

Sourcing Strategies

• Direct Procurement: Engaging with licensed API manufacturers directly ensures control over quality and supply timelines but requires stringent due diligence.

• Authorized Distributors: Working through authorized distributors can streamline supply chain management, provide localized support, and facilitate regulatory compliance.

• Partnerships and Licensing Agreements: Collaborations with regional manufacturers enable access to cost-effective supplies while maintaining adherence to quality standards.

---

Regulatory and Quality Considerations

Quality assurance remains paramount. Suppliers must demonstrate compliance through regulatory certifications, stability data, and batch records. For healthcare institutions and pharmaceutical companies, conducting periodic audits of suppliers is essential to prevent supply disruptions and ensure patient safety.

Quality Challenges & Solutions:

• Variability in API potency can compromise drug efficacy.
• Impurities and contaminants must be below specified limits.
• Validation of sterilization and handling processes for injectable formulations.

---

Future Outlook

The demand for dobutamine hydrochloride is expected to grow, driven by the increasing prevalence of heart failure worldwide. Suppliers investing in innovative manufacturing processes, sustainable practices, and regulatory compliance will be better positioned to capitalize on this growth. Additionally, the era of biosimilar and generic medications promotes a diversified supplier landscape, potentially reducing costs and improving global access.

---

Key Takeaways

• Leading global suppliers of dobutamine hydrochloride include Pfizer, Hospira, Teva, and Chinese manufacturers such as Jiangsu Hengrui and Jiangsu Nhwa.
• Regulatory compliance, manufacturing quality, and supply chain stability are critical factors in supplier selection.
• Diversification across regional suppliers reduces reliance on a single source and mitigates risk.
• Initiatives to verify supplier credentials, conduct audits, and ensure transparency are vital for procurement success.
• Growing demand necessitates strategic partnerships and continual assessment of supply options to meet global healthcare needs.

---

FAQs

1. Who are the top natural or synthetic API manufacturers for dobutamine hydrochloride?
The principal API manufacturers include Pfizer, Jiangsu Hengrui, Jiangsu Nhwa, and Teva. These companies produce pharmaceutical-grade dobutamine hydrochloride complying with international standards.

2. What are the common regulatory certifications required for suppliers?
Suppliers should possess GMP certification, along with ISO 9001 or ISO 13485, and approvals from agencies like the FDA, EMA, or Chinese NMPA, depending on the market.

3. How does regional regulation affect the sourcing of dobutamine hydrochloride?
Regional regulations influence supplier accreditation, permitting, and importation. Suppliers must meet local standards, impacting the choice based on geographical markets.

4. Are there any emerging suppliers disrupting the traditional dobutamine market?
Yes. Several Chinese and Indian API manufacturers are expanding their market share through cost-effective production and improved quality standards, thereby offering competitive alternatives.

5. What factors influence the decision to procure dobutamine hydrochloride from a particular supplier?
Quality assurance, regulatory compliance, supply reliability, cost competitiveness, and existing contractual relationships are the primary factors influencing supplier selection.

---

References

[1] U.S. Pharmacopeia. (2022). USP Monograph for Dobutamine Hydrochloride.
[2] European Medicines Agency. (2021). Guidelines on Good Manufacturing Practice.
[3] Pfizer Inc. Corporate Reports and Product Literature.
[4] Jiangsu Hengrui Medicine Co., Ltd. Annual Report 2022.
[5] Teva Pharmaceutical Industries. Product Portfolio Documentation.

---

Note: All information provided aligns with publicly available data as of early 2023 and should be cross-validated with current regulatory documentation before procurement decisions.