Suppliers and packagers for MIDODRINE HYDROCHLORIDE

MIDODRINE 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
Alembic	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	214734	ANDA	Alembic Pharmaceuticals Limited	46708-338-31	100 TABLET in 1 BOTTLE (46708-338-31)	2021-01-22
Alembic	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	214734	ANDA	Alembic Pharmaceuticals Limited	46708-338-71	500 TABLET in 1 BOTTLE (46708-338-71)	2021-01-22
Alembic	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	214734	ANDA	Alembic Pharmaceuticals Limited	46708-339-31	100 TABLET in 1 BOTTLE (46708-339-31)	2021-01-22
Alembic	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	214734	ANDA	Alembic Pharmaceuticals Limited	46708-339-71	500 TABLET in 1 BOTTLE (46708-339-71)	2021-01-22

Suppliers for the Pharmaceutical Drug: Midodrine Hydrochloride

Last updated: July 30, 2025

Introduction

Midodrine Hydrochloride is a prodrug that converts to its active form, desglymidodrine, which acts as an alpha-1 adrenergic agonist. It is primarily prescribed to treat symptomatic orthostatic hypotension—a condition characterized by blood pressure drops when standing. As demand for effective management of this condition persists, a robust supply chain becomes critical. This report examines the key suppliers of Midodrine Hydrochloride globally, analyzing their manufacturing capabilities, regulatory status, and market presence to inform supply chain strategies for pharmaceutical companies, healthcare providers, and investors.

Overview of Midodrine Hydrochloride Manufacturing

The synthesis of Midodrine Hydrochloride involves complex chemical processes requiring hermetic manufacturing facilities to ensure potency, purity, and compliance with Good Manufacturing Practices (GMP). The drug's manufacturing landscape is concentrated among established pharmaceutical suppliers with extensive expertise in adrenergic agents and solid regulatory track records ([1]).

Leading Suppliers of Midodrine Hydrochloride

1. Mitsubishi Tanabe Pharma Corporation

Overview: Mitsubishi Tanabe Pharma, headquartered in Japan, is a prominent player in the cardiovascular and neurology pharmacology sectors. The company holds multiple patents and licensed manufacturing rights for Midodrine Hydrochloride, actively supplying it across Asia, North America, and Europe.

Manufacturing Capability: Mitsubishi Tanabe possesses advanced production facilities certified under international standards (ISO 13485, GMP). Their supply chain integrates rigorous quality control, ensuring compliance with both U.S. FDA and EMA regulations.

Market Presence: They dominate several markets, especially in Japan and North America, through direct manufacturing and licensing agreements. Their extensive distribution network ensures reliable supply and prompt delivery for global markets.

2. Sun Pharmaceutical Industries Ltd.

Overview: Indian multinational Sun Pharma has expanded into the cardiovascular drug sector, including the production of Midodrine Hydrochloride through strategic partnerships and internal manufacturing facilities.

Manufacturing Capability: Sun Pharma operates GMP-certified plants, capable of large-scale production of complex APIs and finished formulations. Their vertical integration allows control over raw materials and intermediates.

Market Presence: While primarily serving the Indian subcontinent and Asian markets, Sun Pharma increasingly penetrates North American and European markets via licensing arrangements and direct sales.

3. L.B. Pharma Ltd. (Lyons Pharmaceuticals)

Overview: L.B. Pharma, operating under Lyons Pharmaceuticals, supplies Midodrine Hydrochloride chiefly within North America and Latin America. They focus on generic formulations, emphasizing affordability without compromising quality.

Manufacturing Capability: Their facilities adhere to cGMP standards, with a capacity for both bulk API production and finished dosage forms. They maintain multiple validation certificates aligned with international pharmacopeias.

Market Presence: They maintain strategic partnerships with local distributors, ensuring widespread availability in developed markets.

4. Teva Pharmaceutical Industries Ltd.

Overview: As a leading generic pharmaceutical manufacturer, Teva manufactures and markets Midodrine Hydrochloride through licensed agreements, particularly in European markets.

Manufacturing Capability: Teva's manufacturing units maintain rigorous compliance with GMP, supported by advanced R&D capabilities aimed at optimizing API purity and production efficiency.

Market Presence: Their extensive global network ensures reliable supply, especially in Europe and certain parts of Asia.

5. Additional Notable Manufacturers

• Hetero Drugs Ltd. (India): Focuses on generic APIs, including Midodrine Hydrochloride, with GMP-certified facilities.
• Sino Biopharmaceutical Limited (China): Developing a manufacturing footprint for Asian markets.
• Dr. Reddy's Laboratories (India): Has capabilities for both API manufacturing and finished formulations.

Regulatory and Supply Chain Considerations

Reliability of suppliers hinges not only on manufacturing capacity but also on regulatory compliance, supply chain stability, and intellectual property management. Suppliers such as Mitsubishi Tanabe and Teva have long-standing FDA and EMA approvals, ensuring minimal regulatory hurdles for buyers. In contrast, newer entrants or regional manufacturers must secure requisite filings and certifications, which may impact supply continuity.

Supply chain resilience is increasingly vital, especially in light of disruptions caused by global crises like the COVID-19 pandemic. Leading suppliers tend to have contingency manufacturing sites, diversified sourcing, and robust logistical operations to mitigate risks.

Market Trends Impacting Supplier Dynamics

The global market for Midodrine Hydrochloride is influenced by several factors:

• Growing prevalence of orthostatic hypotension among aging populations raises demand.
• Generic drug markets expand supplier options, intensifying competition.
• Regulatory evolutions may constrain or facilitate manufacturing license transfers and patent expirations.
• Strategic alliances between pharmaceutical innovators and contract manufacturing organizations (CMOs) enhance production scalability.

Future Outlook

The supply landscape for Midodrine Hydrochloride is expected to evolve with increased entry from emerging markets, ongoing patent expirations, and technological advancements in synthesis. Companies investing in GMP-compliant facilities and streamlining supply chain logistics will be better positioned to capitalize on rising demand.

Key Takeaways

• Established players like Mitsubishi Tanabe, Sun Pharma, and Teva dominate the Midodrine Hydrochloride supply chain, offering reliable, regulatory-compliant products across multiple markets.
• Market expansion is driven by aging populations and the increasing prevalence of orthostatic hypotension, translating into higher demand.
• Regulatory approvals, GMP certification, and supply chain robustness are critical factors when selecting suppliers.
• Strategic collaborations and licensing agreements significantly influence market access and manufacturing capacity.
• The industry trend toward generic drugs and regional manufacturing is likely to diversify the supplier base further.

FAQs

1. What are the primary regions where Midodrine Hydrochloride suppliers are concentrated?
Suppliers are primarily based in North America, Europe, and Asia, with key manufacturing hubs in Japan (Mitsubishi Tanabe), India (Sun Pharma, Dr. Reddy's, Hetero), and Israel (Teva).

2. How do regulatory standards influence supplier reliability?
Regulatory standards such as GMP and certifications like FDA, EMA, and ISO ensure quality and compliance, directly impacting a supplier's credibility and ability to supply globally.

3. Are there regional differences in Midodrine Hydrochloride supply?
Yes. Regional suppliers tend to focus on local or neighboring markets due to regulatory, logistical, and cost considerations. Global suppliers often maintain multiple manufacturing sites to serve diverse markets.

4. What factors should buyers consider when selecting a Midodrine Hydrochloride supplier?
Buyers should assess regulatory compliance, manufacturing capacity, supply chain stability, Quality Assurance protocols, and licensing status.

5. Is the Midodrine Hydrochloride market expected to see new entrants?
Yes. Given the increasing demand, especially in aging populations, emerging markets and contract manufacturers may enter the space, potentially increasing supplier diversity and competition.

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Sources:

1. U.S. Food and Drug Administration (FDA). Approved Drug Products. https://www.accessdata.fda.gov/scripts/cder/daf/
2. European Medicines Agency (EMA). Marketing Authorization Holder Database.
3. Company Websites: Mitsubishi Tanabe Pharma, Sun Pharma, Teva Pharmaceutical Industries, Hetero Drugs Ltd.