metoprolol tartrate: 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
Baxter Hlthcare Corp	METOPROLOL TARTRATE	metoprolol tartrate	INJECTABLE;INJECTION	078950	ANDA	Baxter Healthcare Corporation	36000-033-10	10 VIAL in 1 CARTON (36000-033-10) / 5 mL in 1 VIAL	2012-09-25
Baxter Hlthcare Corp	METOPROLOL TARTRATE	metoprolol tartrate	INJECTABLE;INJECTION	078950	ANDA	Cardinal Health 107, LLC	55154-4451-5	5 VIAL in 1 BAG (55154-4451-5) / 5 mL in 1 VIAL	2012-09-25
Baxter Hlthcare Corp	METOPROLOL TARTRATE	metoprolol tartrate	INJECTABLE;INJECTION	078950	ANDA	Medical Purchasing Solutions, LLC	71872-7155-1	1 VIAL in 1 BAG (71872-7155-1) / 5 mL in 1 VIAL	2012-09-25
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Metoprolol Tartrate is a widely prescribed beta-adrenergic blocker used primarily for managing hypertension, angina pectoris, and heart failure. As a critical cardiovascular medication, its supply chain spans multiple regions, including North America, Europe, and Asia. Ensuring a reliable source of high-quality Metoprolol Tartrate is essential for healthcare providers, pharmaceutical companies, and regulators. This article provides a comprehensive overview of key suppliers involved in the manufacturing and distribution of Metoprolol Tartrate, highlighting their roles, manufacturing capabilities, and compliance standards.

Manufacturers and Suppliers of Metoprolol Tartrate

1. Major Pharmaceutical Companies Producing Metoprolol Tartrate

A. Novartis AG

Overview: Novartis is a global leader in the production of cardiovascular medications, including Metoprolol Tartrate. Their manufacturing facilities adhere to stringent quality and regulatory standards, such as Good Manufacturing Practices (GMP).
Supply Capabilities: Novartis supplies Metoprolol Tartrate in various forms, including tablets and injectable formulations, across numerous markets worldwide.
Quality Assurance: The company’s adherence to international certifications like FDA, EMA, and WHO ensures high-quality standards.

B. Astrup Company

Overview: As a prominent generic pharmaceutical manufacturer, Astrup specializes in producing active pharmaceutical ingredients (APIs) and finished dosage forms.
API Production: Astrup manufactures Metoprolol Tartate API, supplying to generic drug producers and for export.
Market Focus: The company primarily supplies to North America, Europe, and emerging markets with competitive pricing.

C. Teva Pharmaceutical Industries Ltd.

Overview: Teva is one of the world's largest generic pharmaceutical companies, producing a broad range of cardiovascular drugs, including Metoprolol Tartrate.
Manufacturing: Their facilities are compliant with GMP and undergo regular audits for regulatory compliance.
Distribution Network: Teva’s extensive distribution channels ensure broad availability of Metoprolol Tartrate globally.

D. Hikma Pharmaceuticals

Overview: Hikma specializes in generic medicines, including beta-blockers like Metoprolol Tartrate.
Manufacturing Facilities: Located across the Middle East and Europe, Hikma’s facilities meet international quality standards.
Supply Chain: Hikma supplies to various markets, focusing on affordability and reliability.

2. API Manufacturers of Metoprolol Tartrate

A. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)

Profile: A significant API manufacturer in China, accredited with ISO and other regulatory standards.
API Production: Supplies high-quality Metoprolol Tartrate API to global generic manufacturers.
Regulatory Compliance: Meets standards for export to North America and Europe.

B. Mylan N.V. (Part of Viatris)

Note: Mylan historically supplied API as well as finished formulations, with manufacturing facilities in India and Europe.

C. Wockhardt Ltd. (India)

Profile: Wockhardt manufactures both APIs and finished drugs in compliance with international standards.
Market Reach: Supplies API to various generic drug makers worldwide.

Key Factors in Supplier Selection

Quality and Regulatory Approval: Suppliers must comply with GMP, ISO, and other relevant certifications. Regulatory approvals from agencies like the FDA, EMA, or Health Canada are critical indicators of quality.

Manufacturing Capacity & Reliability: Consistent supply is vital for ongoing clinical needs and commercial demand. Capacity constraints or supply disruptions can impact patient care.

Price Competitiveness: While quality remains a priority, pricing influences procurement decisions, especially for large-volume generic manufacturers.

Geographical Presence: Suppliers with diversified manufacturing sites reduce risks associated with regional disruptions, such as geopolitical instability or natural disasters.

Supply Chain Challenges and Considerations

Regulatory Hurdles: Suppliers must ensure compliance with evolving regulations, including drug listing and approval updates.
Raw Material Sourcing: The quality of precursor materials and APIs directly affects overall product quality; suppliers sourcing from reputable raw material providers are preferred.
Market Demand Fluctuations: The rise in cardiovascular disease prevalence maintains high demand, necessitating scalable supplier operations.
Supply Disruptions: Global events like the COVID-19 pandemic have highlighted vulnerabilities; diversifying suppliers and manufacturing sites is recommended.

Emerging Trends in Supplier Networks

Local API Production: Countries are incentivizing local API manufacturing to reduce dependency on imports, as seen in India and China.
Regulatory Harmonization: Organizations like the International Council for Harmonisation (ICH) promote global standards, simplifying supplier qualification processes.
Sustainability and ESG Compliance: Increasing procurement emphasis on suppliers’ environmental, social, and governance (ESG) practices.

Conclusion

The supply landscape for Metoprolol Tartrate encompasses a mixture of multinational pharmaceutical giants, regional manufacturers, and API producers. Ensuring a reliable, high-quality supply chain necessitates careful vendor assessment based on regulatory compliance, manufacturing capacity, cost, and geopolitical resilience. Strategic partnerships and diversified sourcing are essential to mitigate risks and meet global cardiovascular treatment demands effectively.

Key Takeaways

Leading suppliers include Novartis, Teva, Hikma, and API manufacturers like Zhejiang Hisun Pharmaceutical, with robust global presence and regulatory compliance.
Quality assurance and GMP standards are non-negotiable criteria for selection, ensuring patient safety and product efficacy.
Supply chain disruptions can impact availability; diversification and strategic sourcing reduce such risks.
Emerging trends favor localized API production and sustainability initiatives, shaping future procurement strategies.
Regulatory harmonization facilitates supplier qualification, streamlining the procurement process.

FAQs

1. Who are the largest global producers of Metoprolol Tartrate?
Major producers include Novartis, Teva, Hikma, and API manufacturers like Zhejiang Hisun Pharmaceutical, primarily serving international markets.

2. What regulatory standards should suppliers meet for supplying Metoprolol Tartrate?
Suppliers should comply with GMP, ISO, and hold approvals from agencies such as the FDA, EMA, or equivalent authorities.

3. How can healthcare providers ensure the reliability of their Metoprolol Tartrate supply?
By engaging with diversified suppliers, conducting regular quality audits, and establishing long-term contractual agreements.

4. Are there regional differences in supplier availability?
Yes. North American and European markets predominantly rely on domestic manufacturers, while Asian suppliers play vital roles in global generic supply chains.

5. What future trends could impact the supplier landscape for Metoprolol Tartrate?
Ongoing efforts toward local API manufacturing, regulatory harmonization, and sustainability practices are shaping the evolving supplier network.

Sources

[1] Novartis Annual Report 2022.
[2] Teva Pharmaceuticals Official Website.
[3] Zhejiang Hisun Pharmaceutical Co., Ltd. Certification and Product Portfolio.
[4] ISO and GMP Certification Bodies.
[5] World Health Organization's List of Certified API Manufacturers.

Suppliers and packagers for generic pharmaceutical drug: metoprolol tartrate