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Last Updated: December 12, 2025

Suppliers and packagers for generic pharmaceutical drug: ATENOLOL; CHLORTHALIDONE


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ATENOLOL; CHLORTHALIDONE

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Novitium Pharma ATENOLOL AND CHLORTHALIDONE atenolol; chlorthalidone TABLET;ORAL 215560 ANDA MARLEX PHARMACEUTICALS, INC 10135-733-01 100 TABLET in 1 BOTTLE (10135-733-01) 2022-03-01
Novitium Pharma ATENOLOL AND CHLORTHALIDONE atenolol; chlorthalidone TABLET;ORAL 215560 ANDA MARLEX PHARMACEUTICALS, INC 10135-734-01 100 TABLET in 1 BOTTLE (10135-734-01) 2022-03-01
Novitium Pharma ATENOLOL AND CHLORTHALIDONE atenolol; chlorthalidone TABLET;ORAL 215560 ANDA ANI Pharmaceuticals, Inc. 70954-390-10 100 TABLET in 1 BOTTLE (70954-390-10) 2021-10-25
Novitium Pharma ATENOLOL AND CHLORTHALIDONE atenolol; chlorthalidone TABLET;ORAL 215560 ANDA ANI Pharmaceuticals, Inc. 70954-391-10 100 TABLET in 1 BOTTLE (70954-391-10) 2021-10-25
Unichem ATENOLOL AND CHLORTHALIDONE atenolol; chlorthalidone TABLET;ORAL 213302 ANDA Unichem Pharmaceuticals (USA), Inc. 29300-400-01 100 TABLET in 1 BOTTLE (29300-400-01) 2020-11-25
Unichem ATENOLOL AND CHLORTHALIDONE atenolol; chlorthalidone TABLET;ORAL 213302 ANDA Unichem Pharmaceuticals (USA), Inc. 29300-400-05 500 TABLET in 1 BOTTLE (29300-400-05) 2020-11-25
Unichem ATENOLOL AND CHLORTHALIDONE atenolol; chlorthalidone TABLET;ORAL 213302 ANDA Unichem Pharmaceuticals (USA), Inc. 29300-401-01 100 TABLET in 1 BOTTLE (29300-401-01) 2020-11-25
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drugs: Atenolol and Chlorthalidone

Last updated: July 27, 2025

Introduction

The pharmaceutical landscape for cardiovascular and antihypertensive medications continues to evolve amid increasing demand for quality, reliable supply, and cost-effective procurement. Two prominent drugs in this sector are Atenolol, a beta-blocker, and Chlorthalidone, a thiazide-like diuretic. Accurate identification of key suppliers for these medications helps pharmaceutical companies, healthcare providers, and procurement specialists optimize sourcing strategies, ensure regulatory compliance, and mitigate supply chain risks.

Overview of Atenolol and Chlorthalidone

Atenolol is a selective beta-1 adrenergic receptor blocker primarily used to treat hypertension, angina pectoris, and to prevent recurrent myocardial infarctions. Its global demand stems from its proven efficacy and favorable safety profile.

Chlorthalidone is a long-acting diuretic utilized in managing hypertension and edema, often prescribed alone or in combination therapy. Its pharmacokinetic profile offers advantages over similar diuretics, leading to its preference in certain treatment protocols.

Global Suppliers and Manufacturers

Major Producers of Atenolol

  1. Gulam Rasool & Brothers Limited (Pakistan)
    A prominent manufacturer offering bulk APIs (Active Pharmaceutical Ingredients). Their facilities are G.M.P. compliant, and they serve clients across North America, Europe, and Asia.

  2. Shandong Xinhua Pharmaceutical Co., Ltd. (China)
    Recognized for extensive API production, Xinhua Pharma supplies Atenolol to several multinational pharmaceutical firms. They boast ISO and G.M.P. certifications, ensuring product quality.

  3. Hetero Labs Limited (India)
    With a significant API manufacturing capacity, Hetero supplies Atenolol globally, leveraging their ISO-certified manufacturing plants and robust R&D.

  4. Jubilant Life Sciences (India)
    Producing both APIs and formulations, Jubilant supplies Atenolol to several pharmaceutical companies worldwide. Their manufacturing facilities adhere to international quality standards.

  5. Mundipharma (Germany/Global)
    Besides their proprietary formulations, Mundipharma sources Atenolol from reliable APIs for their branded and generic products.

Key Suppliers of Chlorthalidone

  1. Sun Pharmaceutical Industries Ltd. (India)
    One of the largest generic manufacturers globally, Sun Pharma produces Chlorthalidone in bulk, serving markets across several continents.

  2. TEVA Pharmaceuticals (Israel)
    TEVA is a leading supplier of generic drugs, including Chlorthalidone. Their extensive manufacturing footprint ensures supply security.

  3. Aurobindo Pharma (India)
    With a broad API portfolio, Aurobindo supplies Chlorthalidone to pharmaceutical companies worldwide, under stringent quality control.

  4. Mylan (USA/Global)
    Mylan manufactures and markets Chlorthalidone as part of their generic portfolio, adhering to high regulatory standards.

  5. Sanofi (France/Global)
    While primarily known for branded formulations, Sanofi sources high-quality APIs, including Chlorthalidone, for their proprietary drugs.

Regional Market Dynamics

  • India and China dominate the API manufacturing sector for these drugs, leveraging economies of scale and established supply chains. The Indian pharmaceutical industry holds approximately 20-25% of the global API market for hypertension drugs, according to the Indian Pharmaceutical Alliance (IPA) [1].

  • Europe and North America primarily utilize API imports from Asian manufacturers, though some local producers (e.g., Mylan in the U.S.) maintain integrated supply chains.

  • Regulatory compliance (G.M.P., ISO certifications) plays a crucial role in supplier selection, especially for export-sensitive markets.

Emerging Trends and Strategic Considerations

  • Supply chain diversification is increasingly critical in mitigating risks associated with geopolitical tensions or manufacturing disruptions. Companies are expanding supplier networks beyond traditional regions.

  • API manufacturing consolidation enhances quality control but could pose supply risks if dominant suppliers face operational issues. Strategic partnerships and dual sourcing are recommended.

  • Regulatory compliance ensures market access; suppliers with rigorous adherence to G.M.P. and ISO standards are prioritized.

  • Cost considerations remain influential, but quality assurance and supply security often outweigh price reductions.

Regulatory and Quality Standards

Suppliers operating in this space must adhere to international standards:

  • G.M.P. (Good Manufacturing Practice): Ensures consistent quality, safety, and efficacy.

  • ISO Certification: Enhances credibility and compliance with international guidelines.

  • FDA and EMA approvals: Particularly relevant for suppliers aiming to export to the U.S. and European markets.

Conclusion: Strategic Sourcing for Atenolol and Chlorthalidone

Sourcing from reputable, certified API manufacturers remains paramount. Indian and Chinese suppliers are dominant due to cost advantages and capacity, yet North American and European firms are increasingly seeking diversified supply chains to ensure resilience. Establishing reliable partnerships with G.M.P.-compliant suppliers like Hetero Labs, Sun Pharma, and TEVA guarantees product quality and regulatory compliance. The ongoing trend toward supply chain diversification emphasizes the importance of vetting supplier certifications, capacity stability, and geopolitical risks.


Key Takeaways

  • The global supply of Atenolol and Chlorthalidone predominantly originates from India, China, and Israel, with major manufacturers demonstrating high quality standards.

  • Diversifying supplier bases and prioritizing G.M.P. and ISO certifications enhance supply security and compliance.

  • Regulatory landscape and market-specific certifications influence supplier selection, particularly for exports.

  • Cost efficiency remains essential but must be balanced with quality and reliability to prevent interruptions.

  • Long-term planning should incorporate risk assessments, geopolitical considerations, and contingency strategies for API sourcing.


FAQs

1. Which are the top global suppliers for Atenolol?
Top suppliers include Indian firms like Hetero Labs and Jubilant Life Sciences, Chinese producers such as Shandong Xinhua Pharmaceutical, and European companies like Mundipharma, all adhering to international quality standards.

2. Are Chinese API manufacturers trusted for Chlorthalidone?
Yes. Companies like Shandong Xinhua and others have demonstrated consistent quality, ISO, and G.M.P. compliance, making them reliable sources for global markets.

3. How does regulatory compliance impact API sourcing?
Regulatory compliance ensures that APIs meet quality, safety, and efficacy standards, facilitating market approval and reducing legal and safety risks.

4. What role does cost play in selecting API suppliers?
While cost remains a significant factor, quality assurance and supply stability often take precedence, particularly for high-volume, regulated markets.

5. How can companies mitigate supply chain risks for these drugs?
Diversifying suppliers across regions, establishing strategic stockpiles, assessing supplier certifications, and engaging in long-term contracts help reduce dependency risks.


Sources

[1] Indian Pharmaceutical Alliance (IPA). "India’s API Industry Overview," 2022.

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