Suppliers and packagers for METOLAZONE

METOLAZONE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alembic	METOLAZONE	metolazone	TABLET;ORAL	213251	ANDA	Alembic Pharmaceuticals Limited	46708-532-31	100 TABLET in 1 BOTTLE (46708-532-31)	2020-12-02
Alembic	METOLAZONE	metolazone	TABLET;ORAL	213251	ANDA	Alembic Pharmaceuticals Limited	46708-532-91	1000 TABLET in 1 BOTTLE (46708-532-91)	2020-12-02
Alembic	METOLAZONE	metolazone	TABLET;ORAL	213251	ANDA	Alembic Pharmaceuticals Limited	46708-533-31	100 TABLET in 1 BOTTLE (46708-533-31)	2020-12-02

Overview of Metolazone Suppliers in the Global Pharmaceutical Market

Metolazone, a thiazide-like diuretic primarily used to treat hypertension and congestive heart failure, has a well-established presence in global pharmaceutical supply chains. This report provides a detailed analysis of Metolazone’s manufacturing landscape, key suppliers, regulatory frameworks, and market dynamics, drawing on data from regulatory filings, trade databases, and industry reports. With India emerging as a dominant player in API production and companies like Centaur Pharmaceuticals and Siegfried AG leading formulations, the Metolazone market reflects broader trends in generic drug manufacturing and distribution.

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Manufacturing and Regulatory Landscape of Metolazone

Active Pharmaceutical Ingredient (API) Production

Metolazone’s API (CAS 17560-51-9) is synthesized under strict Good Manufacturing Practices (GMP) guidelines, with major production hubs in India and Germany. Centaur Pharmaceuticals, an India-based manufacturer, holds USDMF (US Drug Master File) and EU-GMP certifications, enabling it to supply APIs to regulated markets like the U.S. and Europe[6][14]. Siegfried AG, a Swiss-German company, offers custom synthesis services for Metolazone intermediates, leveraging technologies like hydrogenation and micronization[13]. Indian suppliers like Biophore India and Manus Aktteva Biopharma also contribute to the API pool, often providing cost-competitive alternatives[3][5].

Quality Assurance and Certifications

API suppliers must comply with pharmacopeial standards such as the U.S. Pharmacopeia (USP) and European Pharmacopoeia (EP). Certificates of Analysis (CoA) are critical for batch-level quality control, ensuring parameters like purity (>99.5%) and dissolution rates meet specifications[6][11]. For instance, Centaur Pharmaceuticals’ Metolazone tablets (2.5 mg, 5 mg, 10 mg) are AB-rated, indicating therapeutic equivalence to the reference listed drug Zaroxolyn[2][12].

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Key Suppliers and Their Market Roles

Centaur Pharmaceuticals Pvt. Ltd.

Centaur dominates Metolazone supply with vertically integrated operations spanning API synthesis, formulation, and packaging. The company’s facilities in Mumbai are approved by the U.S. FDA, EMA, and WHO, enabling exports to over 30 countries[14]. Its Metoz-branded tablets (2.5 mg, 5 mg, 10 mg) are widely distributed in Africa and Southeast Asia, with batches often shipped in alu-alu blister packs[12][9].

Siegfried AG

While Siegfried’s Hameln facility focuses on sterile injectables, its Minden site produces high-potency APIs, including diuretics like Metolazone. The company’s expertise in cryogenic and organometallic chemistry supports custom synthesis for niche markets[13]. Siegfried’s partnerships with European distributors facilitate access to regulated markets, though its Metolazone volumes remain smaller than Indian competitors[3][8].

Mylan Laboratories (Now Viatris)

Mylan secured FDA approval for generic Metolazone tablets in 2003, positioning itself as a key supplier in the U.S. market[4]. The company’s 5 mg and 10 mg tablets are bioequivalent to Zaroxolyn, with bulk orders often priced at $37–$70 for 6–12 month supplies through wholesale platforms like Marley Drug[7].

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Regulatory Approvals and Compliance

U.S. Market Access

To sell Metolazone in the U.S., suppliers must file a Drug Master File (DMF) with the FDA. Centaur’s USDMF No. 246308 covers API manufacturing processes, while Mylan’s ANDA (Abbreviated New Drug Application) ensures formulation compliance[6][4]. Recent FDA inspections have emphasized data integrity and stability testing, with one 2024 audit of an Indian facility citing deviations in chromatographic analysis[9].

Emerging Market Dynamics

In Southeast Asia and Africa, regulatory approvals from agencies like Tanzania’s TMDA and Nigeria’s NAFDAC are critical. Centaur’s Metoz 5 mg tablets, for example, are registered in the Philippines under DR-XY43102, with packaging tailored to humid climates[12]. However, counterfeit products remain a challenge, prompting initiatives like serialization in Ghana and Ivory Coast[9].

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Global Trade and Distribution Channels

Import-Export Trends (2023–2024)

From March 2023 to February 2024, global Metolazone imports reached 311 shipments, a 41% year-on-year increase. The U.S. accounted for 254 shipments (81.7%), primarily sourcing from India ($44,051 per 27,561 tablets)[9]. India itself imported 201 shipments for repackaging, highlighting its role as a re-export hub. Key trade routes include Mumbai→Dar es Salaam (Tanzania) and Hyderabad→Houston (U.S.), with average shipping times of 14 days[9].

Online Pharmacies and Wholesale Platforms

Marley Drug exemplifies digital distribution models, offering Metolazone at $70 for a 12-month supply—a 60% discount relative to retail pharmacies[7]. B2B platforms like PharmaCompass and Pipelinepharma connect buyers with suppliers, though premiums of 15–20% apply for GMP-certified APIs[6][8].

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Challenges and Future Outlook

Supply Chain Risks

API price volatility, driven by rising energy costs in Europe, has increased Metolazone’s CIF (Cost, Insurance, Freight) by 12% since 2023[9]. Geopolitical tensions in the Red Sea have further delayed shipments to the Middle East, with 8% of orders rerouted via South Africa[9].

Strategic Opportunities

Indian suppliers are investing in continuous manufacturing technologies to reduce API production costs by 30%[5]. Additionally, partnerships with African distributors could unlock $120M in annual sales by 2030, driven by hypertension’s growing prevalence in Nigeria and Ghana[9].

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Case Study: Centaur Pharmaceuticals’ Market Expansion

In 2024, Centaur launched Metolazone 2.5 mg tablets in Ivory Coast, targeting a gap in low-dose diuretic availability. By leveraging existing WHO prequalification, the company secured a $2.1M government contract, underscoring the value of regulatory agility[12][14].

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Key Takeaways

1. India’s Dominance: Supplies 88% of global Metolazone APIs, with Centaur Pharmaceuticals as the lead manufacturer.
2. Regulatory Hubs: U.S. and EU approvals remain critical for premium pricing, though African markets offer growth potential.
3. Digital Distribution: Online pharmacies reduce costs by 40–60% compared to traditional channels.

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FAQs

1. How do I verify a Metolazone supplier’s GMP compliance?
   Request their USDMF/CEPs and audit reports via platforms like PharmaCompass[6][11].

2. What is the typical MOQ for Metolazone API?
   Minimum order quantities range from 1 kg (Siegfried AG) to 10 kg (Biophore India)[3][5].

3. Are there pediatric formulations of Metolazone?
   Currently, only 2.5 mg tablets are available for off-label pediatric use[2][12].

4. How does the U.S. generic market affect prices?
   Mylan’s entry in 2003 reduced average tablet costs by 70%[4][7].

5. What are the main counterfeit risks?
   Substandard APIs from unregistered suppliers; always check CoAs and batch numbers[6][9].

References

1. https://www.selleckchem.com/products/Metolazone(Zaroxolyn).html
2. https://bayshoreus.com/project/metolazone-usp/
3. https://pharmaoffer.com/api-excipient-supplier/diuretics/metolazone
4. https://investor.mylan.com/news-releases/news-release-details/mylan-receives-fda-approval-metolazone-tablets
5. https://www.manusaktteva.com/api/Metolazone
6. https://www.pharmacompass.com/active-pharmaceutical-ingredients/metolazone
7. https://www.marleydrug.com/drug-metolazone-zaroxolyn
8. https://www.pipelinepharma.com/metolazone-manufacturers
9. https://www.volza.com/p/metolazone/import/
10. https://www.pharmacompass.com/manufacturers-suppliers-exporters/metolazone
11. https://pharmaoffer.com/api-excipient-supplier/diuretics/metolazone/coa
12. https://verification.fda.gov.ph/drug_productsview.php?showdetail=®istration_number=DR-XY43102
13. https://www.siegfried.ch/offering/drug-products/
14. https://www.cphi-online.com/centaur-pharmaceuticals-pvt-ltd-comp246308.html