Suppliers and packagers for generic pharmaceutical drug: azilsartan kamedoxomil; chlorthalidone

azilsartan kamedoxomil; 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
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331	NDA	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	60631-412-30	30 TABLET in 1 BOTTLE (60631-412-30)	2013-02-01
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331	NDA	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	60631-425-30	30 TABLET in 1 BOTTLE (60631-425-30)	2013-02-01
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331	NDA	Pharma Packaging Solutions, LLC dba Tjoapack LLC	75929-230-03	30 TABLET in 1 BOTTLE (75929-230-03)	2013-02-01

Suppliers for Azilsartan Kamedoxomil and Chlorthalidone: A Comprehensive Market Analysis

Azilsartan kamedoxomil combined with chlorthalidone, marketed under the brand name Edarbyclor, represents a critical therapeutic option for hypertension management. This report examines the global supplier landscape for both the active pharmaceutical ingredients (APIs) and finished formulations of this combination drug. With patents expiring between 2025 and 2031, the market is poised for significant shifts as generic manufacturers like Alkem Laboratories and Zydus Lifesciences enter the fray. Key API suppliers include CTX Lifesciences for azilsartan medoxomil and multinational firms like AXXO GmbH for chlorthalidone, while distribution networks span specialized pharmacies and cold-chain logistics providers.

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Pharmacological Profile of Azilsartan Kamedoxomil and Chlorthalidone

Azilsartan kamedoxomil, a prodrug hydrolyzed to azilsartan in the gastrointestinal tract, selectively inhibits angiotensin II receptors, promoting vasodilation. Chlorthalidone enhances renal sodium excretion through its thiazide-like diuretic action. Together, they synergistically reduce blood pressure by targeting both the renin-angiotensin system and fluid volume[5][6]. The combination’s efficacy in hypertension management has driven demand, with annual U.S. sales reaching $77.9 million as of March 2024[11].

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Global API Suppliers for Azilsartan Medoxomil

CTX Lifesciences: Leader in GMP-Compliant Manufacturing

CTX Lifesciences, headquartered in Surat, India, stands out as a primary supplier of azilsartan medoxomil potassium (CAS 863031-24-7). The company operates US-FDA- and EMA-approved facilities, ensuring compliance with international quality standards. CTX’s drug master file (DMF) support and exports to 87 countries position it as a strategic partner for generic drug developers[1]. Their portfolio includes other angiotensin II receptor blockers, enabling bundled sourcing for combination therapies[1].

Manus Aktteva Biopharma: Specialized Intermediates

Manus Aktteva Biopharma, an ISO 9001:2015-certified Indian firm, provides azilsartan medoxomil intermediates alongside technical documentation for regulatory submissions. This flexibility makes them a preferred partner for manufacturers requiring tailored API solutions[3].

Emerging Competitors in Asia

Pharmacompass lists 50 suppliers, including Metrochem API Private Limited and Ami Lifesciences, which offer azilsartan medoxomil with certifications such as CEP and JDMF. Indian manufacturers dominate this space due to cost efficiencies, though European and U.S. firms like LGM Pharma cater to niche markets requiring strict monograph compliance[2][7].

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Chlorthalidone API Supply Chain Dynamics

AXXO GmbH and Curia: Diversified Sourcing Options

German-based AXXO GmbH supplies chlorthalidone (CAS 77-36-1) globally, while Curia (U.S.) sources its API from Italy. These suppliers emphasize adherence to EP, USP, and JP monographs, critical for markets with rigorous pharmacopeial standards[4][8].

Indian Manufacturing Hub

Unichem Labs, Ipca Labs, and Mylan leverage India’s chemical infrastructure to produce chlorthalidone at competitive prices. Maithri Drugs, for instance, exports to Latin America and the Middle East, highlighting the region’s role in cost-sensitive markets[8].

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Finished Dosage Form Manufacturers

Branded Product: Takeda and Arbor Pharmaceuticals

Takeda Pharmaceutical originally developed Edarbyclor, licensing U.S. commercialization rights to Arbor Pharmaceuticals in 2013. Arbor’s 40 mg/12.5 mg and 40 mg/25 mg tablets account for 94% of branded sales, distributed through McKesson and other wholesalers[12][10].

Generic Entrants Post-Patent Expiry

Alkem Laboratories received FDA approval in January 2025 for azilsartan medoxomil/chlorthalidone tablets, marking the first generic entry. Zydus Lifesciences followed with tentative approval in June 2024, planning production at its Ahmedabad facility[9][11]. These generics are projected to reduce drug costs by 30–50% upon launch.

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Patent Landscape and Market Exclusivity

Core Patents Shaping Supplier Strategies

• US7157584: Covering benzimidazole derivatives, this patent expires in May 2025, removing barriers to azilsartan production[6][9].
• US9387249: Protects the hypertension treatment method using azilsartan and chlorthalidone until July 2031, delaying full generic competition[6][9].

Regulatory Pathways for Generic Suppliers

The FDA’s “abbreviated new drug application” (ANDA) process requires bioequivalence testing against Edarbyclor. Alkem’s AB-rated generic meets these criteria, ensuring therapeutic equivalence[9].

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Distribution Networks and Cold-Chain Logistics

Specialty Pharmacies

Marley Drug offers direct-to-consumer delivery in the U.S., leveraging USPS Priority Mail for 48-hour turnaround. Their wholesale pricing model reduces costs for uninsured patients[13].

Global Access via GNH India

GNH India facilitates international shipments of Edarbyclor through validated cold-chain packaging, ensuring stability for temperature-sensitive APIs. The company provides a 5% discount on inquiries, targeting markets in Africa and Southeast Asia[14].

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Regional Market Analysis

North America: Transition to Generics

With Alkem’s generic launch in 2025, U.S. payers are expected to prioritize cost-saving substitutions. Arbor Pharmaceuticals may counter with patient assistance programs to retain brand loyalty[10][12].

Europe: Stringent Quality Preferences

Suppliers like AXXO GmbH and Menadiona S.L. emphasize GMP compliance to meet EMA standards. The pending expiration of formulation patents (e.g., US9169238 in 2030) will gradually open the market to EU-based generics[4][6].

Asia-Pacific: Manufacturing Dominance

India’s API suppliers, including CTX Lifesciences and Zydus, control 65% of global azilsartan production. China’s emerging manufacturers, however, face regulatory hurdles due to stricter FDA scrutiny[1][11].

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Challenges in Supplier Compliance

Patent Avoidance Strategies

CTX Lifesciences and Manus Aktteva disclaim responsibility for patent infringements, shifting liability to buyers. This poses risks in markets like the U.S., where method-of-use patents remain enforceable until 2031[1][3][6].

Quality Assurance in Generic Supply Chains

Variability in chlorthalidone purity (e.g., anhydric vs. micronized forms) requires rigorous supplier audits. Pharmacompass’s certification filters help identify ISO- and FDA-compliant manufacturers[8][2].

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Future Outlook and Recommendations

Strategic Partnerships for API Security

Generic manufacturers should secure long-term contracts with CTX Lifesciences and AXXO GmbH to mitigate raw material shortages. Vertical integration, as seen with Zydus’s in-house API production, offers additional resilience[11][1].

Investment in Fixed-Dose Combination Technologies

Innovation in tablet stabilization (e.g., pH control agents per US9066936) will differentiate suppliers as generics commoditize[6].

Expansion into Emerging Markets

GNH India’s success highlights demand in regions lacking local manufacturing. Partnerships with African distributors could yield 20% annual growth for suppliers[14].

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Conclusion

The supplier ecosystem for azilsartan kamedoxomil and chlorthalidone is transitioning from a branded monopoly to a competitive generic market. API manufacturers in India and Europe will play pivotal roles, while distributors must navigate patent complexities and quality assurance demands. For healthcare providers, the incoming wave of generics promises improved accessibility, but diligence in supplier selection remains critical to ensuring patient safety.

References

1. https://www.ctxls.com/product/azilsartan-api-manufacturer/
2. https://www.pharmacompass.com/manufacturers-suppliers-exporters/azilsartan-medoxomil
3. https://www.manusaktteva.com/api/Azilsartan+medoxomil
4. https://pharmaoffer.com/api-excipient-supplier/diuretics/chlorthalidone/united-states
5. https://pharmacy.hsc.wvu.edu/media/1137/edarbyclor-azilsartan-chlorthalidone.pdf
6. https://pharsight.greyb.com/ingredient/azilsartan-kamedoxomil;-chlorthalidone-patent-expiration
7. https://www.tradeindia.com/manufacturers/azilsartan.html
8. https://pharmaoffer.com/api-excipient-supplier/diuretics/chlorthalidone
9. https://www.drugs.com/availability/generic-edarbyclor.html
10. https://mms.mckesson.com/product/1223296/Arbor-Pharmaceuticals-60631042530
11. https://www.angelone.in/news/zydus-lifesciences-scores-fda-nod-hypertension-treatment-medication
12. https://www.takeda.com/en-us/newsroom/news-releases/2013/takeda-and-arbor-announce-a-licensing-agreement-for-edarbi-and-edarbyclor/
13. https://www.marleydrug.com/drug-edarbyclor-azilsartanchlorthalidone
14. https://www.gnhindia.com/products/us-ndc/azilsartan-kamedoxomil-and-chlorthalidone-edarbyclor-60631-412/