Suppliers and packagers for METOPROLOL TARTRATE

METOPROLOL TARTRATE

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

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
Fresenius Kabi Usa	METOPROLOL TARTRATE	metoprolol tartrate	INJECTABLE;INJECTION	091045	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1365-1	5 mL in 1 VIAL (51662-1365-1)	2019-12-08
Fresenius Kabi Usa	METOPROLOL TARTRATE	metoprolol tartrate	INJECTABLE;INJECTION	091045	ANDA	Fresenius Kabi USA, LLC	63323-660-05	10 VIAL in 1 TRAY (63323-660-05) / 5 mL in 1 VIAL (63323-660-01)	2010-10-28
Fresenius Kabi Usa	METOPROLOL TARTRATE	metoprolol tartrate	INJECTABLE;INJECTION	091045	ANDA	Fresenius Kabi USA, LLC	65219-665-05	10 VIAL in 1 TRAY (65219-665-05) / 5 mL in 1 VIAL (65219-665-01)	2024-12-13
Gland	METOPROLOL TARTRATE	metoprolol tartrate	INJECTABLE;INJECTION	204205	ANDA	Sagent Pharmaceuticals	25021-303-05	10 VIAL in 1 CARTON (25021-303-05) / 5 mL in 1 VIAL	2010-05-10

Metoprolol Tartrate Suppliers and Market Dynamics

Last updated: February 19, 2026

Metoprolol tartrate, a selective beta-1 adrenergic receptor blocker, is a widely prescribed medication for hypertension, angina pectoris, and myocardial infarction. The global market for metoprolol tartrate is characterized by a diverse supplier base, with manufacturing concentrated in regions with established pharmaceutical production capabilities. Key suppliers operate under stringent regulatory oversight, ensuring product quality and compliance. Market trends are influenced by generic competition, supply chain resilience, and evolving global health demands.

Who are the Primary Suppliers of Metoprolol Tartrate?

The primary suppliers of metoprolol tartrate active pharmaceutical ingredient (API) and finished dosage forms are located across North America, Europe, and Asia. These manufacturers adhere to Good Manufacturing Practices (GMP) as mandated by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

• API Manufacturers:

  • Teva Pharmaceuticals Industries Ltd. (Israel) - A significant player in the global generics market, Teva manufactures APIs for a wide range of pharmaceuticals, including metoprolol tartrate.
  • Mylan N.V. (Netherlands/USA, now part of Viatris) - Historically a major supplier of generic APIs and finished products, Mylan’s portfolio included metoprolol tartrate. Viatris continues this presence.
  • Aurobindo Pharma Limited (India) - A leading vertically integrated pharmaceutical company, Aurobindo has a substantial API manufacturing capacity and supplies metoprolol tartrate.
  • Dr. Reddy's Laboratories (India) - Another prominent Indian pharmaceutical company with a global footprint, Dr. Reddy’s manufactures and markets metoprolol tartrate API.
  • Sun Pharmaceutical Industries Ltd. (India) - Sun Pharma is one of the world's largest generic pharmaceutical companies, with metoprolol tartrate among its API offerings.
  • Hetero Drugs Limited (India) - A large Indian pharmaceutical company focusing on APIs and finished dosages, Hetero is a notable supplier of metoprolol tartrate.
  • Zydus Lifesciences Limited (India) - Formerly Cadila Healthcare, Zydus Lifesciences produces a broad spectrum of APIs, including metoprolol tartrate.
  • Amneal Pharmaceuticals (USA) - Amneal is a US-based pharmaceutical company that manufactures and markets a variety of generic drug products, including metoprolol tartrate.
  • Catalent Pharma Solutions (USA) - While primarily a contract development and manufacturing organization (CDMO), Catalent offers manufacturing services that can include metoprolol tartrate formulations.
  • Novartis AG (Switzerland) - Through its generics division, Sandoz, Novartis has historically been involved in the supply of metoprolol tartrate, though focus may shift to higher-value products.

• Finished Dosage Form Manufacturers and Marketers:

  • Companies listed above often market finished dosage forms (tablets, injections) in addition to APIs.
  • Major Generic Marketers: Numerous companies worldwide market generic metoprolol tartrate, sourcing APIs from the above and other manufacturers. These include brands found in major pharmacies globally.

What are the Regulatory and Quality Standards for Metoprolol Tartrate Production?

The production of metoprolol tartrate is governed by stringent regulatory frameworks to ensure patient safety and product efficacy. Key standards include:

• Good Manufacturing Practices (GMP): Compliance with cGMP (current Good Manufacturing Practices) is mandatory. This encompasses facility design, equipment, personnel training, process validation, quality control, and documentation. Regulatory bodies like the FDA (21 CFR Parts 210 and 211) and EMA (EudraLex Volume 4) set forth these requirements [1].
• Drug Master Files (DMFs): API manufacturers submit DMFs to regulatory agencies (e.g., FDA DMFs) containing confidential detailed information about facilities, processes, or articles used in manufacturing, processing, packaging, and storing the drug substance. This allows drug product manufacturers to reference the DMF in their applications without accessing the proprietary data [2].
• Pharmacopeial Standards: Metoprolol tartrate must meet the specifications outlined in major pharmacopeias, including the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.). These standards define identity, purity, strength, and quality attributes [3].
• Impurity Profiling: Strict controls are placed on impurities, including process-related impurities and degradation products. Regulatory agencies require manufacturers to identify, quantify, and control these impurities within acceptable limits (e.g., ICH Q3A and Q3B guidelines) [4].
• Environmental Monitoring: Manufacturing facilities are subject to environmental monitoring to prevent microbial contamination and ensure a controlled production environment, especially for sterile dosage forms.

What are the Market Trends and Competitive Landscape for Metoprolol Tartrate?

The metoprolol tartrate market is largely dominated by generic competition, leading to price sensitivity and a focus on efficient manufacturing.

• Generic Market Dominance: Metoprolol tartrate has long been off-patent. The market is characterized by a large number of generic manufacturers, both of API and finished dosage forms. This leads to intense price competition and lower profit margins compared to branded or newer drugs.
• API Sourcing and Supply Chain: Indian and Chinese manufacturers hold a significant share of the global API market for metoprolol tartrate due to cost advantages. However, recent global events have highlighted the importance of supply chain resilience. Pharmaceutical companies are increasingly diversifying their supplier base to mitigate risks associated with single-source dependency or geopolitical instability.
• Regulatory Scrutiny: While the market is mature, regulatory bodies continue to enforce quality standards. Manufacturers with a history of compliance and strong regulatory track records are favored. Periodic inspections and stringent quality audits by customers are common.
• Demand Stability: Metoprolol tartrate remains a first-line treatment for several cardiovascular conditions. This ensures a stable and consistent demand for the drug, even in a competitive generic landscape. The aging global population contributes to sustained demand for cardiovascular medications.
• Manufacturing Efficiency: Companies that can achieve high yields, optimize production processes, and manage raw material costs effectively are best positioned to compete. Backward integration into key starting materials can also provide a competitive edge.
• Geographic Distribution: While manufacturing is concentrated, finished dosage forms are distributed globally. Major markets include the United States, Europe, and emerging economies. Local regulatory approvals and distribution networks are critical for market access.

What are the Key Factors Influencing Metoprolol Tartrate Pricing?

Pricing for metoprolol tartrate is primarily driven by supply-demand dynamics within the generic pharmaceutical sector, alongside manufacturing costs and regulatory compliance.

• Volume of Production: Larger production volumes typically lead to lower per-unit costs due to economies of scale, enabling more competitive pricing.
• Raw Material Costs: The cost of key starting materials and chemical reagents used in metoprolol tartrate synthesis directly impacts the final API price. Fluctuations in commodity markets or the availability of specific precursors can influence this.
• Manufacturing Location and Labor Costs: API and finished product manufacturing costs vary significantly by region. Countries with lower labor and operational expenses often have a pricing advantage, assuming comparable quality standards.
• Regulatory Compliance Costs: Maintaining GMP compliance, conducting rigorous quality control, and managing regulatory filings involve substantial ongoing costs that are factored into pricing.
• Competition Intensity: The number of active suppliers in a specific market segment directly influences pricing. A highly fragmented market with numerous competitors typically results in lower prices.
• Supply Chain Efficiency: Streamlined logistics, inventory management, and reliable delivery networks contribute to cost reduction and can translate into more competitive pricing.
• Customer Volume Commitments: Large-volume purchase agreements with pharmaceutical companies can result in negotiated lower prices for metoprolol tartrate API or finished products.

What are the Potential Risks and Challenges for Metoprolol Tartrate Suppliers?

Suppliers of metoprolol tartrate face several risks and challenges inherent in the generic pharmaceutical market and global supply chains.

• Price Erosion: Continuous price pressure from competitors in the highly commoditized generic market can erode profit margins.
• Regulatory Changes and Non-Compliance: Stricter enforcement of regulatory standards or failure to maintain GMP compliance can lead to product recalls, warning letters, import alerts, or loss of manufacturing licenses, significantly disrupting supply and reputation.
• Supply Chain Disruptions: Dependence on single or limited suppliers for critical raw materials, geopolitical events, natural disasters, or transportation issues can interrupt production and delivery.
• Quality Control Failures: Batch failures or the detection of unexpected impurities can lead to costly recalls and damage customer trust.
• Intellectual Property Issues: While metoprolol tartrate itself is off-patent, suppliers must be vigilant about the intellectual property surrounding novel manufacturing processes or formulations, even in the generic space.
• Environmental, Social, and Governance (ESG) Pressures: Increasing scrutiny on sustainable manufacturing practices, ethical sourcing, and labor conditions can impose new compliance requirements and operational costs.
• Competition from Biosimilars (Not Applicable to Metoprolol Tartrate): While not directly relevant to small molecule generics like metoprolol tartrate, the broader pharmaceutical landscape includes biosimilar competition for biologic drugs, which influences overall market dynamics and investment strategies.

Key Takeaways

• The metoprolol tartrate market is mature and dominated by generic competition, with manufacturing concentrated in India and China for APIs, and globally for finished dosage forms.
• Key suppliers include Teva, Viatris (formerly Mylan), Aurobindo, Dr. Reddy's, Sun Pharma, and Hetero.
• Strict adherence to GMP, pharmacopeial standards, and impurity control is paramount for regulatory approval and market access.
• Market trends are characterized by price competition, a focus on supply chain resilience, and stable demand driven by cardiovascular disease prevalence.
• Pricing is influenced by production volume, raw material costs, manufacturing location, and regulatory compliance expenses.
• Suppliers face risks including price erosion, regulatory non-compliance, supply chain disruptions, and quality control failures.

FAQs

1. Which geographic regions are the largest exporters of Metoprolol Tartrate API? India and China are the largest exporters of Metoprolol Tartrate API due to their established API manufacturing infrastructure and cost advantages.

2. What is the typical shelf life for Metoprolol Tartrate API and finished products? Metoprolol Tartrate API typically has a shelf life of 2 to 5 years when stored under recommended conditions. Finished dosage forms (tablets) generally have a shelf life of 2 to 4 years, as specified by the manufacturer and approved by regulatory bodies.

3. Are there any specific environmental regulations that Metoprolol Tartrate manufacturers must comply with? Yes, manufacturers must comply with local and international environmental regulations regarding chemical waste disposal, emissions control, and wastewater treatment, in addition to pharmaceutical-specific environmental guidelines.

4. How does the FDA typically inspect Metoprolol Tartrate manufacturing facilities? The FDA conducts routine pre-approval inspections (PAI) and routine GMP inspections. Inspections focus on compliance with 21 CFR Parts 210 and 211, assessing data integrity, process validation, quality control systems, and overall adherence to cGMP.

5. What are the implications of a Drug Master File (DMF) submission for a Metoprolol Tartrate supplier? A DMF submission allows a Metoprolol Tartrate API supplier to provide confidential manufacturing details to regulatory agencies like the FDA. This enables drug product manufacturers to reference the DMF in their drug applications (e.g., ANDA), streamlining the approval process without the API supplier disclosing proprietary information to the drug product applicant.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Current Good Manufacturing Practice (CGMP) Regulations. Retrieved from https://www.fda.gov/drugs/guidance-compliance-regulatory-information/current-good-manufacturing-practice-cgmp-regulations

[2] U.S. Food and Drug Administration. (2020, April 15). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/drug-master-files/drug-master-files-dmfs

[3] United States Pharmacopeial Convention. (n.d.). About USP. Retrieved from https://www.usp.org/about-usp

[4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2015). ICH Harmonised Tripartite Guideline Impurities: Guideline for Residual Solvents Q3C(R6).