Bulk Pharmaceutical API Sources for GENOSYL

Bulk Pharmaceutical API Sources for GENOSYL

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		295566_ALDRICH
NovoSeek		145068
ABI Chem		AC1L3QHF
Chembase.cn		318
ChemTik		CTK0H7679

Bulk Active Pharmaceutical Ingredient (API) Sources for Genosyl (Nitroglycerin)

Last updated: July 27, 2025

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Overview of Genosyl (Nitroglycerin)

Genosyl, primarily known for its therapeutic use in angina pectoris, contains nitroglycerin as its active pharmaceutical ingredient (API). Nitroglycerin, a nitric acid ester of glycerol, functions as a potent vasodilator, providing rapid relief in acute cardiac conditions. Ensuring a reliable, high-quality supply of nitroglycerin API is crucial for manufacturing Genosyl and maintaining regulatory compliance. This article examines the global API sourcing landscape, emphasizing key manufacturers and supply considerations.

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Market Landscape of Nitroglycerin API

The global API market for nitroglycerin is characterized by a limited number of specialized manufacturers. Historically, the API supply chain for nitroglycerin has been concentrated in a few regions, predominantly India, China, and Europe, owing to their advanced chemical manufacturing capabilities. The market dynamics involve factors like regulatory standards, raw material procurement, manufacturing capacity, and quality assurance.

Primary sources are tightly regulated due to the explosive and toxic nature of nitroglycerin, which demands strict safety protocols and handling procedures throughout manufacturing. Consequently, suppliers must demonstrate compliance with Good Manufacturing Practices (GMP), environmental regulations, and safety standards established by agencies such as the US FDA, EMA, and comparable authorities.

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Leading API Manufacturers for Nitroglycerin (Genosyl)

1. Piramal Pharma Solutions

• Overview: A global leader with extensive experience in nitroglycerin manufacturing, Piramal operates multiple facilities compliant with cGMP standards.
• Capabilities: Offers bulk APIs suitable for injectable and oral dosage forms, with proven quality control systems.
• Supply Security: Strong reputation for API consistency, backed by rigorous safety protocols.

2. Phosphorex/Hahn Group

• Overview: Specializes in energetic materials and nitro compounds, including nitroglycerin for pharmaceutical applications.
• Capabilities: Provides customized formulations and has a track record of supplying APIs for cardiovascular medications.
• Certifications: GMP-certified manufacturing facilities, with comprehensive safety management.

3. MMS (Mekong Meditech)

• Overview: An emerging supplier from Vietnam with capabilities in energetic chemical synthesis.
• Capabilities: Offers bulk nitroglycerin API, catering to regional markets while expanding globally.
• Regulatory: Compliant with international standards, with ongoing efforts to attain broader GMP certification.

4. Hubei Yimin Chemical Co., Ltd.

• Overview: A Chinese manufacturer focusing on energetic chemicals, including pharmaceutical-grade nitroglycerin.
• Capabilities: Provides large-scale production with emphasis on safety and environmental compliance.
• Challenges: Navigating international import/export regulations due to strict chemical controls.

5. Market-Approved European Suppliers

Some European manufacturers, such as those in Germany and Switzerland, supply nitroglycerin API to pharmaceutical companies, emphasizing high purity, quality, and regulatory compliance. However, specific APIs for Genosyl are often sourced via authorized intermediaries or import licenses.

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Sourcing Considerations for Nitroglycerin API

Regulatory Compliance:
Manufacturers must maintain cGMP standards and be able to provide comprehensive documentation, including Certificates of Analysis (CoA), stability data, and regulatory filings. Given the hazardous nature of nitroglycerin, audits and validation processes are rigorous.

Quality and Purity:
API suppliers should provide high-purity nitroglycerin (typically >99%) with minimal impurities to meet pharmacopoeial standards (USP, EP). Consistent batch-to-batch quality is vital for formulation stability.

Raw Material Security:
Reliable raw material supply chains—such as glycerol, nitric acid, and sulfuric acid—are essential, as their quality impacts API purity and safety.

Safety and Environmental Standards:
Manufacturers must adhere to strict safety procedures, involving explosion-proof facilities, proper waste management, and environmental safeguards, considering the hazardous nature of the product.

Pricing and Lead Times:
Cost competitiveness combined with supply resilience influences sourcing decisions. Lead times depend on manufacturing capacity and regulatory clearance.

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Regional Sourcing Trends

• India: Dominates the bulk API manufacturing sector due to robust chemical infrastructure, lower production costs, and a growing export footprint.
• China: Provides significant capacity, emphasizing scale and cost-effectiveness, with increasing emphasis on quality compliance.
• Europe: Focuses on high-quality, regulated API production with strict adherence to European pharmacopoeial standards.
• North America: Limited but specialized API production, mostly for niche markets or specific formulations.

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Challenges in Sourcing Nitroglycerin API

• Regulatory Stringency: Strict regulations and export controls limit market access.
• Safety Risks: Handling energetic chemicals requires advanced safety protocols, limiting manufacturers.
• Market Concentration: Few players leading to potential supply shortages.
• Environmental and Ethical Concerns: Stringent environmental regulations impact production feasibility and costs.

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Future Outlook

The API sourcing landscape for nitroglycerin remains relatively stable but sensitive to regulatory changes, geopolitical factors, and advances in manufacturing technology. Emerging suppliers from Southeast Asia may enhance supply diversity. Additionally, process innovations aimed at safer manufacturing could expand capacity and reduce costs.

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Key Takeaways

• Leading API manufacturers for Genosyl (nitroglycerin) include Piramal Pharma Solutions, Hahn Group, MMS, and select European suppliers, each emphasizing strict safety and quality standards.
• Sourcing strategies should prioritize regulatory compliance, high purity, and supply reliability due to the product’s hazardous nature.
• Regional dynamics favor India and China for volume, with Europe focusing on high-quality, regulated APIs.
• Challenges include safety risks, regulatory hurdles, and market concentration, which could impact supply stability.
• Strategic partnerships, rigorous supplier qualification, and continuous monitoring are essential for reliable API sourcing.

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Frequently Asked Questions

Q1. What are the primary regulatory agencies overseeing nitroglycerin API manufacturing?
The US Food and Drug Administration (FDA), European Medicines Agency (EMA), and respective national agencies enforce GMP standards crucial for nitroglycerin API production.

Q2. How do safety standards influence API manufacturing for nitroglycerin?
Due to its explosive properties, safety considerations necessitate advanced facilities, explosion-proof equipment, and strict handling protocols, limiting the number of capable manufacturers.

Q3. Are there alternative sources for Genosyl’s API?
While existing suppliers dominate, some emerging manufacturers from Southeast Asia and small-scale validated facilities may serve as alternative sources, contingent upon regulatory approvals.

Q4. What quality certifications should API suppliers possess?
Suppliers should be GMP-certified and compliant with pharmacopeial standards such as USP, EP, or JP, ensuring high purity, stability, and consistent quality.

Q5. How can manufacturers mitigate supply risks for nitroglycerin API?
Diversifying supplier base, establishing long-term agreements, and conducting regular audits help mitigate risks related to safety, regulatory compliance, and supply disruptions.

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References

[1] International Pharmaceutical Abstracts (IPA), 2022. Global APIs market insights.
[2] United States Pharmacopeia (USP), 2023. Standards for nitroglycerin purity and safety.
[3] European Medicines Agency (EMA), 2023. Regulatory requirements for energetic APIs.
[4] Chemical & Engineering News, 2021. Safety and environmental protocols in energetic chemical manufacturing.
[5] GlobalChemical Suppliers Database, 2023. Directory of licensed nitroglycerin API producers.

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