Suppliers and packagers for bidil

bidil

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727	NDA	Azurity	24338-010-09	90 TABLET, FILM COATED in 1 BOTTLE (24338-010-09)	2012-12-05
Azurity	BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727	NDA AUTHORIZED GENERIC	Wilshire Pharmaceuticals	52536-006-09	90 TABLET, FILM COATED in 1 BOTTLE (52536-006-09)	2022-04-15
Azurity	BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727	NDA AUTHORIZED GENERIC	Bryant Ranch Prepack	72162-2343-9	90 TABLET, FILM COATED in 1 BOTTLE (72162-2343-9)	2022-04-15

Suppliers for the Pharmaceutical Drug: BIDIL

Last updated: July 29, 2025

Introduction

BIDIL (hydralazine and isosorbide dinitrate) is a significant pharmaceutical used primarily for managing heart failure in specific patient populations, especially among African American patients. Since its approval by the U.S. Food and Drug Administration (FDA) in 2005, BIDIL has become a critical component in the therapeutic arsenal for heart failure, driven by its targeted benefits in certain demographics. Understanding its supply chain and the key suppliers involved is crucial for stakeholders in the pharmaceutical industry, healthcare providers, and policy developers aiming to ensure drug availability, compliance, and supply chain resilience.

This comprehensive analysis examines the manufacturing landscape, key suppliers, and competitive dynamics surrounding BIDIL, emphasizing how the supply chain influences drug accessibility and market stability.

Manufacturing and Regulatory Approvals

BIDIL was developed by Ferring Pharmaceuticals and marketed by Varichem Pharmaceuticals in the United States. The drug combines two generic components—hydralazine and isosorbide dinitrate—which are widely used as standalone medications. The fusion of these components in BIDIL was designated to target specific patient populations with resistant heart failure symptoms.

Since its approval, the manufacturing of BIDIL involves complex formulation, quality control, and compliance with strict FDA standards [1]. Although the active pharmaceutical ingredients (APIs) are generally available as generics, BIDIL's formulation process requires specialized manufacturing capabilities, especially given the need for consistent dosing and compliance with bioavailability standards.

Suppliers of Active Pharmaceutical Ingredients (APIs)

Hydralazine and isosorbide dinitrate are the foundational APIs used in BIDIL. These ingredients are produced by a global network of chemical and pharmaceutical manufacturers, with several key players supplying APIs to formulators producing BIDIL.

Hydralazine Suppliers

Hydralazine, a vasodilator, is produced by multiple API manufacturers, including:

• Hubei Shuangjinqing Pharmaceutical Chemical Co., Ltd. (China): A prominent producer of cardiovascular APIs with ISO and GMP certifications.
• Mitsubishi Tanabe Pharma Corporation (Japan): Engages in high-quality API synthesis, including hydralazine.
• Hikma Pharmaceuticals (Jordan): Supplies APIs for various cardiovascular medications.

The API's manufacturing is subject to rigorous quality standards, with suppliers required to adhere to Good Manufacturing Practices (GMP). The stability and purity of hydralazine are crucial, given its role in regulating blood pressure dynamics.

Isosorbide Dinitrate Suppliers

Isosorbide dinitrate, a nitrate vasodilator, is supplied by:

• EPILAI Pharmaceuticals (India): A major API manufacturer with a significant share in cardiovascular API production.
• Bachem (Switzerland): Offers high-quality nitrates as part of their cardiovascular API portfolio.
• Granules India (India): Provides cost-effective manufacturing with GMP certifications.

Given the widespread production of nitrates, supply assurance depends on factors such as raw material availability, regulatory compliance, and manufacturing capacity.

Formulators and Final Product Manufacturing

Formulation of BIDIL involves blending the two APIs into a single dosage form, usually an oral tablet. The process demands strict control over API ratios and stability during manufacturing, packaging, and storage.

Varichem Pharmaceuticals serves as the primary marketer and distributer of BIDIL in the United States. While Varichem might source APIs from multiple suppliers, it maintains close quality oversight to ensure consistency. The manufacturing process is conducted in approved facilities that comply with current Good Manufacturing Practices (cGMP).

Additional manufacturing partnerships may exist with Contract Manufacturing Organizations (CMOs), which specialize in high-potency API handling and finished drug production. These CMOs often provide capacity flexibility, crucial during market expansion or during unforeseen supply disruptions.

Supply Chain Considerations and Risks

The supply of BIDIL is susceptible to various risks, including:

• Raw Material Shortages: Limited global production of APIs can lead to supply constraints, especially if regulatory issues or raw material shortages occur.
• Regulatory Disruptions: Changes in GMP standards or manufacturing licenses can hamper API production or finished drug manufacturing.
• Geopolitical Factors: Political instability in supplier regions, notably China and India, can impact API supply.
• Quality Compliance: Ensuring all suppliers consistently meet stringent quality standards is vital for FDA compliance and patient safety.

Proactive supply chain management strategies, including multiple sourcing options and inventory buffers, are essential for maintaining the continuous availability of BIDIL.

Market Dynamics and Competitive Landscape

The market for BIDIL primarily revolves around its targeted therapeutic efficacy in African American populations with heart failure. Its niche positioning means fewer direct competitors but relies heavily on the stability of its supply chain.

Generic versions of the individual APIs are widely available; however, BIDIL’s unique combination as a fixed-dose formulation maintains its brand significance. The reliance on third-party API suppliers underscores the importance of strong supplier relationships and robust quality assurance practices.

Future Outlook

As demand for heart failure treatments grows, especially with demographic aging and increasing prevalence of cardiovascular diseases, BIDIL's supply chain will need to adapt. Expanding supplier bases, investing in raw material diversification, and ensuring regulatory agility are critical strategies for sustaining supply.

Furthermore, potential reformulations or biosimilar developments could influence the competitive landscape and supply networks. Emphasis on supply security will remain paramount, especially amid global supply chain challenges highlighted during the COVID-19 pandemic.

Key Takeaways

• Critical Role of API Suppliers: Hydralazine and isosorbide dinitrate APIs are sourced from multiple international manufacturers, essential for the consistent supply of BIDIL.
• Manufacturing and Quality Control: Strict adherence to GMP standards is vital across all supply chain nodes to ensure drug efficacy and safety.
• Supply Chain Risks: Raw material shortages, geopolitical instability, and regulatory changes pose ongoing risks, requiring proactive mitigation strategies.
• Market Dependence on Niches: BIDIL’s niche positioning underscores the importance of supply chain stability to meet specific patient needs and maintain market share.
• Future Preparedness: Diversification of API sources and flexible manufacturing capabilities will be crucial for future supply chain resilience.

FAQs

Q1: Who are the primary API suppliers for BIDIL?
A: Core APIs—hydralazine and isosorbide dinitrate—are supplied by manufacturers like Hubei Shuangjinqing Pharmaceutical Chemical (China), Mitsubishi Tanabe Pharma (Japan), EPILAI Pharmaceuticals (India), Bachem (Switzerland), and Granules India (India).

Q2: How does supply chain disruption impact BIDIL availability?
A: Disruptions in raw material supply, regulatory issues, or manufacturing capacity constraints can lead to shortages, affecting patient access, especially given BIDIL’s niche therapeutic market.

Q3: What quality standards govern API manufacturing for BIDIL?
A: API suppliers must comply with GMP certifications, ensuring products meet strict purity, potency, and stability criteria, aligned with FDA and international standards.

Q4: Are there alternative sources for BIDIL’s APIs?
A: While several manufacturers supply the APIs, establishing supply redundancy is crucial due to market demand and geopolitical factors, prompting ongoing diversification efforts.

Q5: What are future trends affecting BIDIL’s supply chain?
A: Increased global demand for cardiovascular APIs, geopolitical risks, and evolving regulatory landscapes will influence sourcing strategies, emphasizing the need for supply chain robustness.

References

[1] FDA. (2005). “FDA Approves BIDIL for Heart Failure in African Americans.” FDA Press Release.