Bulk Pharmaceutical API Sources for TRIBENZOR

Bulk Pharmaceutical API Sources for TRIBENZOR

Vendor	Vendor Homepage	Vendor Sku	API Url
Starshine Chemical		2023-05-10B0613

Bulk Active Pharmaceutical Ingredient (API) Sources for TRIBENZOR

Last updated: February 20, 2026

TRIBENZOR (metoprolol, bisoprolol, and hydrochlorothiazide) is a combination product used for hypertension and heart failure. It contains three APIs: metoprolol, bisoprolol, and hydrochlorothiazide (HCTZ). The origin of each API influences manufacturing strategies, regulatory compliance, and supply chain stability.

API Overview

API	CAS Numbers	Function	Common Dosage Forms	Regulatory Status
Metoprolol	37350-58-6	Beta-1 adrenergic blocker	Tablets, extended-release formulations	FDA, EMA approved
Bisoprolol	66714-22-1	Beta-1 selective adrenergic blocker	Tablets	FDA, EMA approved
Hydrochlorothiazide (HCTZ)	58-93-5	Thiazide diuretic	Tablets	FDA, EMA approved

Sources for APIs

Metoprolol

• Manufacturers:

  • GlaxoSmithKline (GSK)—owns original patent and manufacturing facilities.
  • Contract manufacturers like Mirae Bio, Jiangsu Hengrui Medicine.
  • Horizontal supply chain with Chinese and Indian suppliers.

• China:

  • Major producer. Companies such as Zhejiang Huahai Pharmaceutical and Jiangsu Hengrui Medicine supply bulk APIs.
  • Quality standards: GMP compliant, certified by Chinese authorities and often inspected by the US FDA or EMA.

• India:

  • Significant API producers: Cipla, Aurobindo Pharma, Sun Pharma.
  • API grade: Both pharma-grade and grade suitable for formulations.

• Pricing & Capacity:

  • API prices vary with scale and purity, typically ranging from $150 to $300 per kilogram.
  • Capacity varies; large producers can supply multiple metric tons annually.

Bisoprolol

• Manufacturers:

  • Original patents owned by Merck.
  • Generics from Dr. Reddy's, Hetero, and Aurobindo Pharma.
  • API supply predominantly from India, with Chinese companies also involved.

• China:

  • Zhejiang Hisoar Pharmaceutical and other unnamed manufacturers.
  • Strict GMP standards; exports to Europe and the US.

• India:

  • Leading suppliers include Aurobindo Pharma and Cadila.
  • API costs generally range from $200 to $350 per kilogram.
  • Large capacity for high-volume production.

Hydrochlorothiazide (HCTZ)

• Manufacturers:

  • Dow Chemical (historically).
  • Currently: Teva, Mylan, and other generic companies.

• China & India:

  • Widely produced with numerous small to large scale GMP facilities.
  • API prices generally between $50 and $150 per kilogram, reflecting high competition.

• Supply & Quality:

  • Volatile due to regulatory pressure; high-quality API essential to avoid impurities.

Supply Chain Considerations

• Global Regulatory Inspections:

  • Chinese API manufacturers increasingly inspected by FDA and EMA.
  • Indian manufacturers hold existing approvals but face periodic re-inspection.

• Quality Standards:

  • Suppliers must demonstrate compliance with International Conference on Harmonisation (ICH) standards.
  • Certificates of Analysis (CoA) and batch certification are critical.

• Pricing & Capacity Trends:

  • API prices trending downward due to increased competition.
  • Supply chain disruptions reported during pandemic, prompting diversification.

• Trade Wars & Policies:

  • US-China tensions impact tariffs and sourcing decisions.
  • India has positioned as a major supplier, affecting pricing dynamics.

Strategic Sourcing Approaches

• Vertical integration with Chinese or Indian producers ensures reliable supply.
• Multiple sourcing reduces risk of shortages.
• Quality assurance through audits and third-party testing.

Summary Table

API	Main Production Countries	Key Suppliers	Price Range ($/kg)	Regulatory Status
Metoprolol	China, India	Jiangsu Hengrui, Aurobindo	150-300	GMP, FDA, EMA approved
Bisoprolol	China, India	Zhejiang Hisoar, Aurobindo	200-350	GMP, FDA, EMA approved
HCTZ	China, India	Teva, Mylan	50-150	GMP, FDA, EMA approved

Key Takeaways

• Major sources for TRIBENZOR APIs include Chinese manufacturers (Jiangsu Hengrui, Zhejiang Hisoar) and Indian companies (Aurobindo, Dr. Reddy's).
• API pricing varies, with metoprolol and bisoprolol being more expensive due to complexity and demand.
• Quality standards are critical; FDA and EMA-inspected facilities are preferred for regulatory compliance.
• Supply security involves diversified sourcing, especially considering geopolitical and pandemic-related disruptions.
• Regulatory developments increasingly influence sourcing decisions and supply chain strategies.

FAQs

1. Are Chinese API manufacturers compliant with US and European standards?
Many Chinese manufacturers now achieve GMP compliance and are inspected by the FDA or EMA, but verification remains crucial.

2. How do API prices impact the overall cost of TRIBENZOR?
API costs are a significant portion; fluctuations affect wholesale pricing and profitability.

3. What regulatory hurdles exist for sourcing APIs internationally?
Regulatory approval depends on GMP certification, quality documentation, and inspection history.

4. Can alternative APIs be used in TRIBENZOR formulations?
Alternatives are limited; the proven combination depends on specific pharmacological profiles.

5. How does supply chain disruption influence API sourcing strategies?
Manufacturers diversify suppliers and hold safety stock to mitigate risks.

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References

[1] U.S. Food and Drug Administration. (2022). API Inspection Reports.
[2] European Medicines Agency. (2022). GMP Inspection Reports.
[3] IQVIA. (2022). API Market Report.
[4] GlobalData. (2022). API Production Capacity & Pricing Trends.
[5] Indian Pharmaceutical Alliance. (2022). API Manufacturing and Export Data.