Suppliers and packagers for ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Anda Repository	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	075909	ANDA	Dr. Reddy's Laboratories Limited	55111-133-01	100 TABLET in 1 BOTTLE (55111-133-01)	2001-10-15
Anda Repository	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	075909	ANDA	Dr. Reddy's Laboratories Limited	55111-133-10	1000 TABLET in 1 BOTTLE (55111-133-10)	2001-10-15
Anda Repository	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	075909	ANDA	Dr. Reddy's Laboratories Limited	55111-134-01	100 TABLET in 1 BOTTLE (55111-134-01)	2001-10-15

Suppliers for the Pharmaceutical Drug: Enalapril Maleate and Hydrochlorothiazide

Last updated: July 29, 2025

Introduction

The combination of enalapril maleate and hydrochlorothiazide (HCTZ) is widely prescribed for managing hypertension and congestive heart failure. As a fixed-dose formulation, this combination offers enhanced therapeutic efficacy through synergistic mechanisms: enalapril is an angiotensin-converting enzyme (ACE) inhibitor that reduces blood pressure by vasodilation, while hydrochlorothiazide, a thiazide diuretic, decreases plasma volume. Effective procurement of this combination requires identifying reliable suppliers capable of meeting quality standards, regulatory compliance, and supply consistency.

Market Overview and Industry Landscape

The global pharmaceutical industry has a robust supply chain network for enalapril maleate and hydrochlorothiazide, driven by high demand in developed and emerging markets. The primary sources include both branded and generic manufacturers, with a significant proportion operating under strict Good Manufacturing Practice (GMP) compliance. Industry giants like Novartis, Teva Pharmaceuticals, and Mylan have historically supplied this combination, alongside numerous regional manufacturers.

Key Suppliers of Enalapril Maleate and Hydrochlorothiazide

1. Major Global Manufacturers

a. Novartis AG
Novartis is one of the pioneering companies in producing enalapril-based medications, including enalapril maleate formulations. Its scale, extensive R&D, and manufacturing capabilities position it as a leading supplier globally. The company adheres to stringent regulatory standards, making its products suitable for markets with high compliance requirements, including US, Europe, and Japan.

b. Teva Pharmaceuticals
Teva ranks among the world's largest generic pharmaceutical manufacturers with broad access to raw materials and a robust quality assurance system. It produces enalapril maleate and hydrochlorothiazide combination tablets, serving both domestic and international markets, often at competitive prices.

c. Mylan (now part of Viatris)
Viatris, successor to Mylan, supplies a wide array of antihypertensive combinations, including enalapril maleate and HCTZ. The company has extensive manufacturing facilities and a global distribution network, emphasizing affordability alongside quality.

d. Sandoz (a Novartis division)
Sandoz specializes in producing high-quality generic formulations, including enalapril maleate and HCTZ combinations, primarily targeting European and North American markets.

e. Lupin Limited
An Indian-based pharmaceutical firm, Lupin manufactures enalapril maleate and hydrochlorothiazide as part of its cardiovascular product portfolio. It meets international standards and supplies to numerous emerging markets.

2. Regional and Contract Manufacturers

Numerous regional manufacturers, especially in India and China, produce enalapril maleate and hydrochlorothiazide. These suppliers often offer cost-effective options but require rigorous quality assessments and certification verification.

a. Hetero Labs
An Indian pharmaceutical company with a significant portfolio of cardiovascular drugs, including enalapril maleate and HCTZ. It operates under GMP and adheres to WHO standards.

b. Cadila Pharmaceuticals
Based in India, Cadila provides generic enalapril and hydrochlorothiazide formulations, with export licenses to numerous countries.

c. Zhejiang Huahai Pharmaceutical
A Chinese producer of active pharmaceutical ingredients (APIs) and finished formulations, including enalapril maleate, with a growing reputation for quality compliance.

d. Aurobindo Pharma
Another Indian manufacturer supplying both APIs and finished products for enalapril maleate and HCTZ, widely distributed across Asia, Africa, and South America.

3. API Suppliers

Since active pharmaceutical ingredients are the core of formulations, sourcing high-quality APIs is critical.

• Novartis (for enalapril maleate API, where produced internally or via licensed suppliers)
• Zhejiang Huahai Pharmaceutical
• Hetero
• Aurobindo Pharma
• Sun Pharma

These API suppliers are typically certified by international regulatory agencies (e.g., US FDA, EMA), ensuring compliance with pharmacopoeial standards.

Certifications and Regulatory Compliance

Choosing suppliers with validated GMP certification, US FDA approval (for North American markets), EMA approval (for Europe), or adhering to WHO prequalification is imperative. Many suppliers possess multiple certifications, signifying their suitability for international markets.

Key certifications include:

• GMP Certification
• FDA Approval or Inspection Reports
• ISO Certifications (ISO 9001, ISO 13485)
• WHO GMP Prequalification

Regulatory compliance ensures the safety, efficacy, and quality of the pharmaceutical products supplied.

Supply Chain Considerations

Quality Assurance: Rigorously evaluate suppliers’ quality control measures, batch consistency, and stability data.

Pricing and Lead Times: Balance cost-effectiveness with delivery reliability. Indian and Chinese suppliers often offer competitive pricing but may have longer lead times or import restrictions in certain territories.

Regulatory Approvals: Confirm that suppliers' formulations and APIs are approved by relevant health authorities in your target markets.

Capacity and Scalability: Assess whether suppliers can meet potential increases in demand, especially amid global health crises such as COVID-19, which has strained supply chains for cardiovascular medications.

Emerging Trends and Challenges

• Supply Chain Disruptions: Raw material shortages, geopolitical tensions, and pandemic impacts may affect supply stability.
• Regulatory Divergences: Variations in country-specific approvals necessitate thorough compliance checks.
• Quality Concerns: Counterfeit or substandard APIs and formulations pose risks; verifying supplier credentials minimizes these issues.
• Sustainability and Ethical Practices: Growing emphasis on environmentally sustainable and ethically sourced manufacturing affects supplier selection.

Concluding Remarks

The pharmaceutical market for enalapril maleate and hydrochlorothiazide encompasses a broad network of reputable global and regional suppliers. Industry leaders like Novartis, Teva, Mylan/Viatris, and Sandoz stand out for their rigorous quality standards and extensive distribution channels. Regional players such as Lupin, Hetero, and Cadila offer cost-effective alternatives suitable for emerging markets. Ultimately, effective sourcing hinges on balancing quality, regulatory compliance, supply reliability, and cost.

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Key Takeaways

• Global leaders such as Novartis and Teva dominate the enalapril maleate and hydrochlorothiazide supply chain, offering high-quality, regulatory-compliant products.
• Regional manufacturers in India and China provide cost-effective options but require careful due diligence regarding quality standards.
• API quality and certifications (GMP, FDA, EMA, WHO prequalification) are critical factors for supplier selection.
• Supply chain resilience must be prioritized through diversified sourcing and capacity assessments.
• Staying aligned with regulatory changes and market trends ensures sustained access to this essential cardiovascular medication.

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Frequently Asked Questions (FAQs)

1. Are generic versions of enalapril maleate and hydrochlorothiazide equally effective as branded ones?
Yes. Generic formulations, when produced by GMP-certified manufacturers, meet the same standards for safety and efficacy as branded counterparts.

2. What should I consider when selecting a supplier for API versus finished formulations?
API quality, regulatory certifications, and manufacturing capacity are crucial for API sourcing. For finished formulations, focus on formulation compliance, stability data, and batch-to-batch consistency.

3. Which regulatory agencies oversee the manufacturing standards for these drugs?
The primary agencies include the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and WHO, which set standards for GMP compliance and prequalification.

4. How do supply chain disruptions impact the availability of enalapril maleate and hydrochlorothiazide?
Disruptions can lead to shortages, delays, or price increases. Diversifying suppliers and maintaining inventory buffers mitigate these risks.

5. Can regional suppliers meet international quality standards?
Yes, many Indian and Chinese suppliers hold international certifications and export to developed markets, but thorough validation and audits are recommended before procurement.

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References

[1] IQVIA, “Global Cardiovascular Drugs Market Report,” 2022.
[2] USFDA Database, “Approved Manufacturer Listings,” 2023.
[3] WHO Prequalification Programme, “List of Qualified API Suppliers,” 2023.
[4] Novartis Annual Report, 2022.
[5] Teva Pharmaceuticals, “Product Portfolio and Quality Certifications,” 2023.