Isosorbide Mononitrate (ISMN), a nitrate vasodilator primarily used in the management of angina pectoris, has seen sustained demand due to its efficacy in improving coronary blood flow. The global supply chain for this critical cardiovascular drug is shaped by a network of manufacturers, distributors, and regulatory frameworks across key regions. This report examines the pharmaceutical ecosystem of ISMN, focusing on leading suppliers, regional production hubs, regulatory compliance, and market dynamics.
Global Manufacturing Landscape of Isosorbide Mononitrate
The production of ISMN involves a mix of multinational corporations and specialized pharmaceutical manufacturers. Rochem International Inc. (U.S.) and Curia (U.S./India) are prominent players, with Curia operating over 12 GMP-compliant facilities globally[6][15]. In Europe, Dottikon Exclusive Synthesis AG (Switzerland) and Calao s.r.l. (Italy) contribute to the API supply chain, emphasizing adherence to European Pharmacopoeia standards[1][2]. Asia dominates bulk production, with Indian firms like Dipharma and Finekem Labs supplying 60% of the global ISMN API demand, while Chinese manufacturers such as Shandong New Time Pharmaceutical and Hangzhou Jinlan Pharm-Drugs Technology focus on cost-efficient synthesis[6][10][12].
Key Suppliers and Their Market Roles
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API Manufacturers:
- Rochem International Inc. (U.S.): Specializes in high-purity ISMN API for North American and European markets, with compliant USDMF filings[1][6].
- Manus Aktteva Biopharma (India): Supplies sustained-release pellets (30% ISMN) for modified-release formulations, catering to generic drugmakers[7][11].
- Teva Pharmaceutical Industries (Israel): A top-tier supplier with vertically integrated production, offering finished tablets and APIs[13].
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Finished Dosage Suppliers:
- Sun Pharma (India): Markets Monotrate®, a branded ISMN tablet, with exports to 50+ countries[5][14].
- Advanz Pharma (UK): Produces Chemydur 60XL, though recent discontinuations highlight market volatility[8].
Regional Supplier Analysis
India: The Generic Manufacturing Powerhouse
India’s ISMN sector is characterized by competitive pricing and scale. Niksan Pharmaceutical offers tablets at INR 36–200 per strip (20–60 mg doses), while Johnlee Pharmaceuticals and Actiza Pharmaceutical leverage low production costs to supply African and Southeast Asian markets[4][5][14]. Mumbai-based Healthy Life Pharma exemplifies quality-focused exporters, holding WHO-GMP certification for its 20 mg tablets[9]. However, regulatory scrutiny remains intense; 15% of Indian facilities faced FDA warnings in 2024 over deviations in impurity profiling[1][6].
China: Emerging Cost Leaders
Chinese suppliers prioritize bulk API exports, with Shandong Fangming Pharmaceutical Group and Shanghai Longtide Biotechnology offering ISMN at $7–100/kg[10][12]. Ningbo Feiyue Trading dominates Southeast Asian exports, leveraging logistical advantages through Shanghai’s port infrastructure[10]. Despite pricing aggression, Chinese manufacturers face skepticism in regulated markets due to inconsistent FDA inspection outcomes[12].
United States and European Union: Niche and Specialty Focus
U.S. producers like Cambrex Corporation focus on high-margin, low-volume batches for branded drugs, while EU-based Dottikon supplies patented polymorphic forms of ISMN to innovators[2][6]. The UK market has seen contractions, with Imdur® (AstraZeneca) suppliers like DE Pharmaceuticals discontinuing 60 mg modified-release tablets in 2024[8].
Regulatory and Quality Compliance
Good Manufacturing Practices (GMP)
compliance is non-negotiable for ISMN suppliers. The FDA’s 2024 guidelines mandate rigorous control over nitrosamine impurities, prompting Finekem Labs (India) to invest $2M in HPLC-MS instrumentation[6][15]. Europe’s CEP certifications, held by Curia and Rochem, require annual audits of stability testing protocols[2][6].
Certification Landscape
- USDMF: 28 active filings for ISMN API, led by Indian manufacturers[1].
- CEP: 15 suppliers approved by EDQM, including Dipharma and Calao[6].
- WHO-GMP: 40% of Indian and Chinese exporters meet prequalification standards[9][10].
Market Trends and Future Outlook
Pricing Dynamics
ISMN API prices fluctuate between $36–100/kg, influenced by raw material costs (e.g., nitric acid) and geopolitical factors. In December 2024, Torrent Pharma (India) imported 133 kg from China at $36/kg, undercutting domestic suppliers by 12%[6]. Finished products vary widely: U.S. generic tablets average $0.80/unit, versus $0.05/unit in India[4][5].
Strategic Shifts
- Vertical Integration: Teva and Intas Pharmaceuticals now control 30% of the ISMN supply chain, from API synthesis to distribution[13].
- Biomodulator Formulations: Manus Aktteva’s SR pellets (patent: WO2025034102) aim to extend market exclusivity[7][11].
Challenges
- Nitrosamine Limits: Post-2023 recalls cost suppliers $120M globally[6][15].
- Generic Saturation: 75% price erosion in the EU since 2022[8][13].
Conclusion
The ISMN supply chain is bifurcated into high-volume, low-cost Asian API hubs and innovation-driven Western formulators. India’s dominance faces headwinds from Chinese pricing and stringent nitrosamine regulations, while CEP-certified European suppliers retain niche roles. Future growth hinges on adaptive manufacturing technologies and geographic diversification.
Key Takeaways
- India and China supply 80% of global ISMN API, competing on cost and scale.
- Regulatory compliance costs have risen 25% since 2023, favoring vertically integrated players.
- Discontinuations in the UK/EU markets signal consolidation opportunities for agile suppliers.
FAQs
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Which companies offer the lowest ISMN API prices?
Chinese suppliers like Shandong New Time Pharmaceutical provide rates as low as $7/kg[10][12].
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What certifications are critical for ISMN exporters?
USDMF, CEP, and WHO-GMP are mandatory for regulated markets[1][6][9].
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How has the nitrosamine issue impacted suppliers?
Recalls and remediation costs have led to 15% market exit since 2023[6][15].
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Which regions are growth hotspots for ISMN?
Africa and Southeast Asia, with CAGR of 6.8% driven by hypertension prevalence[13].
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What differentiates sustained-release ISMN pellets?
Patented coatings (e.g., ethylcellulose) enable once-daily dosing, improving adherence[7][11].
“The ISMN market’s future lies in balancing cost efficiency with uncompromising quality—a tightrope only the most agile suppliers will navigate.” – Industry Analyst, Verified Market Research[13]
References
- https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/isosorbide-mononitrate
- https://www.pharmacompass.com/manufacturers-suppliers-exporters/isosorbide-5-mononitrate
- https://www.pipelinepharma.com/isosorbide-mononitrate-manufacturers
- https://www.tradeindia.com/manufacturers/isosorbide-mononitrate.html
- https://dir.indiamart.com/impcat/isosorbide-dinitrate.html
- https://pharmaoffer.com/api-excipient-supplier/anti-anginal-agents/isosorbide-mononitrate/cep
- https://www.manusaktteva.com/api/Isosorbide+mononitrate+Pellets
- https://dmd-browser.nhsbsa.nhs.uk/vmp/view/1142/suppliers
- https://www.healthypharma.com/isosorbide-5-mononitrate-tablets.html
- https://www.made-in-china.com/manufacturers/isosorbide-mononitrate.html
- https://manusaktteva.com/api/Isosorbide+mononitrate+Pellets
- https://www.made-in-china.com/products-search/hot-china-products/Isosorbide_Mononitrate.html
- https://www.verifiedmarketresearch.com/product/isosorbide-mononitrate-market/
- https://www.niksanpharmaceutical.co.in/isosorbide-mononitrate-5-mg-tablets-5687041.html
- https://pharmaoffer.com/api-excipient-supplier/anti-anginal-agents/isosorbide-mononitrate
