PHENOXYBENZAMINE HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal	PHENOXYBENZAMINE HYDROCHLORIDE	phenoxybenzamine hydrochloride	CAPSULE;ORAL	212568	ANDA	Amneal Pharmaceuticals NY LLC	60219-1502-1	100 CAPSULE in 1 BOTTLE (60219-1502-1)	2020-10-30
Aurobindo Pharma	PHENOXYBENZAMINE HYDROCHLORIDE	phenoxybenzamine hydrochloride	CAPSULE;ORAL	215600	ANDA	Burel Pharmaceuticals, LLC	35573-473-02	100 CAPSULE in 1 BOTTLE (35573-473-02)	2023-05-08
Aurobindo Pharma	PHENOXYBENZAMINE HYDROCHLORIDE	phenoxybenzamine hydrochloride	CAPSULE;ORAL	215600	ANDA	Aurobindo Pharma Limited	59651-327-01	100 CAPSULE in 1 BOTTLE (59651-327-01)	2023-05-08
Aurobindo Pharma	PHENOXYBENZAMINE HYDROCHLORIDE	phenoxybenzamine hydrochloride	CAPSULE;ORAL	215600	ANDA	NorthStar Rx LLC	72603-229-01	100 CAPSULE in 1 BOTTLE (72603-229-01)	2024-10-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

Phenoxybenzamine Hydrochloride (PHBZ) is a non-selective alpha-adrenergic antagonist primarily used in the management of pheochromocytoma, a catecholamine-secreting tumor of the adrenal medulla. Its ability to block alpha-adrenergic receptors reduces hypertension episodes caused by excess catecholamines. The demand for PHBZ spans hospitals, compounding pharmacies, and pharmaceutical manufacturers, necessitating a reliable and compliant supplier network. This report details key suppliers globally recognized for providing pharmaceutical-grade Phenoxybenzamine Hydrochloride, examining their capacities, regulatory compliance, and market positioning.

Market Overview of Phenoxybenzamine Hydrochloride

Phenoxybenzamine Hydrochloride is a specialized pharmaceutical ingredient with specific manufacturing and quality standards. Because it is utilized in sensitive therapeutic applications, vendors must comply with stringent manufacturing practices, notably Good Manufacturing Practices (GMP), and possess appropriate certifications such as FDA approval or EMA authorization, depending on the region.

The global market for PHBZ is relatively niche, driven largely by the prevalence of pheochromocytoma cases and related surgical interventions. The primary source countries include India, China, and the United States, where pharmaceutical compound production capabilities are robust.

Major Suppliers of Phenoxybenzamine Hydrochloride

1. Shilpa Medicare Limited – India

Overview:
Shilpa Medicare is a leading Indian manufacturer specializing in active pharmaceutical ingredients (APIs), including PHBZ. Their facilities are GMP-certified and compliant with global standards.

Capabilities:

Extensive API manufacturing capacity with high purity grades suitable for pharmaceutical formulation.
Experience supplying to international markets including North America, Europe, and Asia.
Compliance with US FDA, EU GMP certifications, and ISO standards.

Market Position:
Shilpa Medicare is among the most reliable Indian API suppliers for PHBZ, favored for its quality assurance, cost competitiveness, and regulatory compliance.

2. Zhejiang Hisun Pharmaceutical Co., Ltd. – China

Overview:
Zhejiang Hisun is a prominent Chinese pharmaceutical company with a strong portfolio of raw materials and finished pharmaceuticals. They produce Phenoxybenzamine Hydrochloride as part of their antihypertensive API portfolio.

Capabilities:

Large-scale manufacturing with ISO and GMP certifications.
Commitment to quality control measures aligned with international standards.
Capability to supply bulk quantities with consistent quality.

Market Position:
Has gained recognition for competitive pricing and regulatory compliance, making it a significant supplier for global clients seeking Chinese API manufacturers.

3. Solara Active Ingredients – India

Overview:
Solara Active Ingredients offers a range of APIs and intermediates, including phenoxybenzamine hydrochloride. They emphasize stringent quality standards and flexible supply chain options.

Capabilities:

GMP-certified plants adhering to US FDA and EU standards.
Robust quality control systems with batch-to-batch consistency.
Capable of fulfilling both small and large volume orders.

Market Position:
Known for reliable domestic and international supply, Solara’s focus on quality makes it a competitive source for pharmaceutical manufacturers.

4. Shaanxi Top Pharm Chemical Co., Ltd. – China

Overview:
Shaanxi Top Pharm specializes in the manufacture of pharmaceutical intermediates, including alpha-adrenergic antagonists like PHBZ.

Capabilities:

Focused on high-purity APIs tailored for pharmaceutical uses.
Certifications include ISO, GMP, and internal quality standards.
Ability to customize formulations for specific market needs.

Market Position:
A competitive choice for buyers prioritizing Chinese manufacturing, with an emphasis on quality and affordability.

5. Hikma Pharmaceuticals – United States / Middle East

Overview:
Hikma offers a variety of generic pharmaceuticals and APIs, including phenoxybenzamine hydrochloride for institutional use.

Capabilities:

US FDA-approved manufacturing facilities.
Extensive distribution networks.
Strong regulatory compliance profile.

Market Position:
Primarily supplies finished pharmaceuticals but also supplies APIs to qualified partners; recognized for compliance and prompt delivery.

Criteria for Supplier Selection

When selecting phenoxybenzamine hydrochloride suppliers, pharmaceutical companies should evaluate:

Regulatory Compliance: Certification standards (GMP, FDA, EMA).
Manufacturing Capacity: Ability to meet urgent and large-volume demands.
Quality Assurance: Purity levels, batch consistency, stability data.
Pricing and Lead Time: Cost competitiveness aligned with supply reliability.
Reputation: Track record in the industry, audits, and customer references.
Geographical Considerations: Proximity to manufacturing hubs to minimize logistics delays.

Regulatory Considerations and Supply Chain Risks

The supply of phenoxybenzamine hydrochloride is sensitive to evolving regulatory standards, geopolitical factors, and trade policies. Suppliers operating in India and China face increased scrutiny, emphasizing the importance of audits and supplier qualification processes. It is prudent for buyers to establish long-term partnerships with suppliers who can demonstrate compliance, transparency, and reliable logistics.

Emerging Trends in the Phenoxybenzamine Hydrochloride Market

Increased Quality Demands: Stricter regulatory standards push suppliers to enhance quality assurance protocols.
Supply Chain Diversification: Companies seek multiple vendors across different regions to mitigate risks.
Synthesis Improvements: Efforts toward greener synthesis routes may lead to more sustainable production practices.
Market Expansion: Growing recognition of PHBZ’s therapeutic uses may expand demand, encouraging new entrants.

Conclusion

The procurement of phenoxybenzamine hydrochloride hinges on balancing cost, quality, regulatory compliance, and supply chain resilience. Top-tier suppliers such as Shilpa Medicare (India), Zhejiang Hisun (China), Solara Active, Shaanxi Top Pharm, and Hikma Pharmaceuticals offer reliable sources, each with distinct advantages aligned with stringent pharmaceutical standards.

Choosing the right supplier involves a thorough evaluation of regulatory credentials, manufacturing capacity, and reputation. As the demand for PHBZ persists, fostering strategic partnerships with certified and transparent vendors will be pivotal to ensuring uninterrupted supply and adherence to international quality standards.

Key Takeaways

Reliable sourcing of phenoxybenzamine hydrochloride requires focusing on GMP-certified suppliers with proven regulatory compliance.
Key suppliers include prominent Indian and Chinese manufacturers with global distribution capabilities.
Commercial considerations must consider not only price but also supply chain stability, quality assurance, and regional regulatory environment.
Due diligence, including audits and supplier qualification processes, ensures supplier credibility.
Diversification of supplier base mitigates geopolitical and supply chain risks amid tightening regulations.

FAQs

What are the primary use cases for phenoxybenzamine hydrochloride?
It is predominantly used to manage pheochromocytoma, facilitating preoperative blood pressure control through alpha-adrenergic blockade.
What regulatory standards should suppliers of PHBZ meet?
Suppliers should comply with GMP standards globally, with certifications from agencies such as the US FDA, EMA, or local equivalents, depending on the buyer's region.
Which countries are leading producers of phenoxybenzamine hydrochloride?
India and China are the primary manufacturing hubs, owing to their extensive API production infrastructure.
How can buyers ensure the quality of phenoxybenzamine hydrochloride?
By verifying supplier certifications, review of batch testing reports, purity data, and conducting audits or third-party inspections.
Are there biodegradable or greener alternatives to phenoxybenzamine hydrochloride?
Currently, phenoxybenzamine hydrochloride synthesis involves traditional chemical processes. Research into greener synthesis is ongoing but not yet commercially mainstream.

Sources:

[1] Global Pharmaceutical API Market Report, 2022.
[2] Indian Pharmaceuticals Industry Overview, Department of Pharmaceuticals, Government of India, 2023.
[3] Zhejiang Hisun Pharmaceutical Co., Ltd. Product Portfolio, Official Website, 2023.
[4] ISO Certification Database, Various API Suppliers.

Suppliers and packagers for PHENOXYBENZAMINE HYDROCHLORIDE