Bulk Pharmaceutical API Sources for OSMITROL 20% IN WATER

Bulk Pharmaceutical API Sources for OSMITROL 20% IN WATER

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		HctF@@IaWTfYn~jjj`@@
Sigma-Aldrich		M1902_SIGMA
Sigma-Aldrich		M4125_SIAL
Sigma-Aldrich		M8429_SIAL
Sigma-Aldrich		M9546_SIAL
Sigma-Aldrich		M9647_SIAL
Calbiochem		443907

Bulk Active Pharmaceutical Ingredient (API) Sources for OSMITROL 20% IN WATER

Last updated: August 5, 2025

Introduction

Osmitrol (isosorbide mononitrate) is a vasodilator commonly used in the treatment of angina pectoris. It operates by relaxing blood vessels, thereby reducing cardiac workload and alleviating chest pain. Formulations typically include a 20% concentration of the active pharmaceutical ingredient (API) in aqueous solution. Ensuring a reliable, high-quality supply of isosorbide mononitrate (API) is paramount for manufacturers aiming to produce OSMITROL 20% in water. This article explores the global API sourcing landscape, key suppliers, quality considerations, and industry trends relevant to pharmaceutical companies and stakeholders involved in this segment.

Overview of Isosorbide Mononitrate API

Isosorbide mononitrate is a nitrate derivative synthesized via the nitration of isosorbide. It is characterized by high purity requirements, strict regulatory standards, and stability considerations. The API's complexity necessitates specific manufacturing capabilities, emphasizing the importance of selecting reputable suppliers with validated processes, consistent purity standards, and robust Good Manufacturing Practice (GMP) compliance.

Global API Suppliers for Isosorbide Mononitrate

1. India: A Leading Source

India remains a dominant player in the API market for cardiovascular drugs, including isosorbide mononitrate. Major Indian API manufacturers possess extensive manufacturing experience, cost advantages, and comprehensive regulatory approvals.

• Hetero Labs Ltd.: Recognized globally for their API portfolio, Hetero offers high-quality isosorbide mononitrate APIs compliant with international standards. They operate dedicated GMP facilities, adhering to USFDA, EMA, and WHO guidelines [1].

• Caplin Point Laboratories: This Chennai-based manufacturer supplies various cardiovascular APIs, including isosorbide mononitrate, with an emphasis on quality assurance and regulatory compliance [2].

• Aurobindo Pharma: A significant API producer with a focus on cardiovascular active ingredients, Aurobindo supplies API with robust documentation and high purity levels [3].

2. China: Growing Presence with Quality Assurance Challenges

China has expanded its API manufacturing capacity. Several companies produce isosorbide mononitrate, though regulatory oversight varies.

• Sino Biopharmaceutical Limited: Known for a broad API portfolio, including nitrates, they have scaled production of isosorbide mononitrate pellets and powders, meeting GMP standards [4].

• Shandong Lvbao Pharmaceutical: An emerging manufacturer with capacity for API production, emphasizing quality systems aligned with Chinese regulatory standards [5].

3. Europe: Specialized, High-Cost Suppliers

European companies tend to focus on high-value, high-purity APIs for regulated markets.

• BASF: As a leading supplier of specialty chemicals and APIs, BASF offers top-tier isosorbide mononitrate, leveraging advanced synthesis technologies and strict quality controls [6].

• Evonik Industries: Known more for specialty chemicals, Evonik supplies high-purity APIs, including nitrates, for niche pharmaceutical applications [7].

4. United States: Limited Domestic Production

The domestic U.S. API market for isosorbide mononitrate is limited, with most supply coming from Indian and European manufacturers, due to regulatory and economic factors.

• API Manufacturing via Contract Manufacturers: U.S.-based pharmaceutical companies often outsource production to India or Europe, choosing suppliers based on quality, cost, and regulatory compliance.

Quality and Regulatory Considerations

Supply chain reliability hinges on API manufacturers’ adherence to Good Manufacturing Practices (GMP), validation protocols, and quality standards such as USP, EP, or Ph. Eur. Among core parameters are:

• Purity Levels: Typically >98% purity is mandated, with residual solvents, heavy metals, and impurities carefully controlled.
• Batch Consistency: Critical for formulation stability and efficacy.
• Certifications: GMP certificates, Drug Master Files (DMFs), and registration documents are essential for regulatory approval processes.

In particular, suppliers with approved DMFs or Certificates of Suitability (CEP) facilitate faster registration and manufacturing approvals.

Industry Trends and Sourcing Strategies

1. Diversification of Supply Sources

Developing multiple supplier relationships minimizes supply disruptions, especially considering geopolitical risks and regulatory audits.

2. Focus on Quality Assurance

Regulators globally prioritize API quality; exceeding baseline standards reduces compliance risks and ensures product efficacy.

3. Globalization and Local Manufacturing

While India and China dominate bulk API production, European and North American markets increasingly favor locally sourced APIs to expedite regulatory pathways and ensure quality.

4. Technological Innovation and Green Chemistry

Manufacturers adopting environmentally sustainable synthesis pathways are gaining favor, especially among European suppliers aligning with stricter environmental regulations.

Cost Considerations and Procurement Dynamics

Cost competitiveness in API sourcing is influenced by manufacturing scale, regulatory compliance, geographic location, and quality assurance levels. Indian APIs generally offer cost benefits, but supply chain stability and regulatory acceptance remain paramount. European APIs, though more expensive, often provide advantages in regulatory approval speed and perceived quality.

Regulatory Pathways for API Importation

Importing APIs such as isosorbide mononitrate into regulated markets necessitates comprehensive documentation, quality audits, and compliance with entities like the U.S. FDA, EMA, and other national agencies. Establishing partnerships with suppliers possessing validated DMFs accelerates approval timelines and reduces compliance hurdles.

Conclusion

The supply of bulk isosorbide mononitrate API for OSMITROL 20% in water hinges on selecting dependable, regulated, and high-quality sources. Indian manufacturers dominate the landscape due to manufacturing capacity, cost, and regulatory compliance, but European and Chinese suppliers also serve as viable alternatives. Businesses should prioritize suppliers with proven GMP compliance, robust quality systems, and transparent regulatory documentation. Diversification strategies can mitigate supply chain risks, and ongoing monitoring of technological and regulatory developments is essential for maintaining an optimized API procurement strategy.

Key Takeaways

• India is a primary source for cost-effective, GMP-compliant isosorbide mononitrate APIs.
• European suppliers offer high purity and quicker regulatory pathways, albeit at higher costs.
• Quality assurance, GMP compliance, and regulatory approval documentation are non-negotiable for API sourcing.
• Diversification of suppliers reduces supply chain vulnerability.
• Staying abreast of technological advancements and environmental standards enhances sourcing strategy effectiveness.

FAQs

1. What are the top API manufacturers for isosorbide mononitrate globally?

Leading manufacturers include Hetero Labs, Aurobindo Pharma, and Caplin Point in India; BASF and Evonik Industries in Europe; with Chinese firms like Sino Biopharmaceutical also significant contributors.

2. How can I verify the quality of an API supplier for osmitrol?

Verify the supplier’s GMP certification, review their DMFs or CEPs, assess batch release testing records, and conduct site audits if feasible.

3. What factors influence the cost of sourcing isosorbide mononitrate API?

Key factors include manufacturing scale, geographic location, quality standards, regulatory compliance, and logistical considerations.

4. Are there environmentally sustainable options in API synthesis for isosorbide mononitrate?

Yes, some European suppliers adopt green chemistry principles to reduce environmental impact, which can also align with corporate sustainability goals.

5. How does API sourcing impact the regulatory approval process for osmitrol formulations?

Using APIs from suppliers with approved DMFs or CEPs streamlines regulatory submissions and approvals by ensuring compliance with quality standards.

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References

[1] Hetero Labs Ltd. Corporate brochure.
[2] Caplin Point Laboratories Official Website. API portfolio details.
[3] Aurobindo Pharma Ltd. Regulatory filings and GMP certifications.
[4] Sino Biopharmaceutical Limited. Annual report.
[5] Shandong Lvbao Pharmaceutical Co., Ltd. Production capacity and quality systems overview.
[6] BASF Corporate Sustainability Reports.
[7] Evonik Industries. API manufacturing capabilities and standards documentation.