Bulk Pharmaceutical API Sources for OMIDENEPAG ISOPROPYL

Bulk Pharmaceutical API Sources for OMIDENEPAG ISOPROPYL

Vendor	Vendor Homepage	Vendor Sku	API Url
BioChemPartner		BCP26206
Hairui Chemical		OMJL031
DC Chemicals		DC11044
Synblock Inc		SB18739
MedChemexpress MCE		HY-111406
AbaChemScene		CS-0040499
ChemShuttle		TQR1222

Bulk Active Pharmaceutical Ingredient (API) Sources for: Omidenepag Isopropyl

Last updated: August 2, 2025

Introduction

Omidenepag isopropyl, a selective prostaglandin receptor agonist developed for ophthalmologic applications—primarily to lower intraocular pressure (IOP) in glaucoma and ocular hypertension. As a pivotal active pharmaceutical ingredient (API), its reliable procurement from reputable bulk suppliers is critical for pharmaceutical manufacturers involved in clinical research, formulations, and commercial production. This report provides an in-depth analysis of API sourcing options for omidenepag isopropyl, emphasizing supplier reliability, regulatory considerations, manufacturing scales, and quality assurance practices.

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Overview of Omidenepag Isopropyl API

Omidenepag isopropyl (chemical name: (1S,2S,4R)-4-[(3,4,5-trimethoxyphenyl)amino]-2-[(Z)-4-hydroxy-4-methylpent-2-en-1-yl]cyclopentane-1,2-dicarboxylic acid isopropyl ester) functions as a selective prostaglandin FP receptor agonist, demonstrating significant efficacy in reducing IOP. Its synthesis involves complex organic reactions, high purity standards, and stringent quality control, aligning with regulatory standards such as the USP, EP, or JP monographs, where applicable.

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Key Criteria for Selecting API Suppliers

• Regulatory Compliance: Suppliers must meet cGMP standards compliant with FDA, EMA, or other pertinent regulatory bodies.
• Quality Assurance: Consistent batch-to-batch purity, stability, and absence of impurities.
• Manufacturing Capacity & Lead Time: Adequate production scales aligned with demand cycles.
• Supply Chain Reliability: Proven track record of uninterrupted supply and logistical robustness.
• Transparency & Traceability: Clear documentation, batch records, and quality certificates.

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Major API Suppliers for Omidenepag Isopropyl

1. Traditional Chemical & Custom Synthesis Contract Manufacturers

While omidenepag isopropyl is a novel API, several high-end contract manufacturing organizations (CMOs) are capable of synthesizing complex prostaglandin derivatives. These entities often provide custom synthesis services based on proprietary or collaborative development agreements.

• Lonza (Switzerland): Known for high-purity pharmaceutical ingredients, Lonza’s API manufacturing capabilities encompass complex organic molecules. While not explicitly listed for omidenepag isopropyl, their broader portfolio and advanced cGMP facilities suggest they can scale production upon customer specifications.

• WuXi AppTec (China): Offers comprehensive API synthesis services, including custom complex organic compounds, adhering strictly to international regulatory standards. They have extensive experience with prostaglandin derivatives and similar molecules.

• Boehringer Ingelheim (Germany): A global pharma CDMO with extensive API manufacturing capacity for complex molecules, including high-purity active compounds, potentially capable of producing omidenepag isopropyl at scale.

2. Specialty API Manufacturers & Proprietary Producers

Certain biotech firms focusing on innovative ophthalmic API supply chains might produce omidenepag isopropyl, especially under licensing or partnership agreements.

• Otsuka Pharmaceutical Co., Ltd.: The developer behind omidenepag isopropyl, potentially retains or licenses manufacturing rights to select API producers or has in-house manufacturing capabilities, often partnering with strategic CDMOs.

• Shandong Luoxin Pharmaceutical Group (China): A Chinese API producer with focus on ophthalmic APIs. While specific details are proprietary, their capabilities suggest they could be a source for such complex molecules.

3. Emerging & Contract Manufacturing Sources

The nascent market for omidenepag isopropyl API is evolving, with several emerging contract manufacturers offering customized synthesis services, especially in regions with growing pharmaceutical manufacturing infrastructure.

• Sino Biopharmaceutical Limited (Hong Kong): Potential partner for Asian markets, capable of stable API manufacturing within cGMP environments.

• Korea Good Manufacturing Practice (KGMP) Certified Suppliers: Korea’s pharmaceutical sector develops APIs with high regulatory compliance, including ophthalmic active ingredients.

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Regional Considerations & Regulatory Implications

• United States & Europe: Suppliers must adhere to FDA/EMA cGMP standards, with the ability to provide International Council for Harmonisation (ICH) stability data and comprehensive regulatory documentation.

• Asia-Pacific: Rapidly growing manufacturing hubs with increasing cGMP compliance; suppliers here often offer cost advantages but require careful validation.

• India: Several API manufacturers that have achieved WHO-GMP certification and can produce complex molecules, though due diligence on quality standards remains necessary.

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Supplier Qualification and Due Diligence

• Verify current cGMP certification and audit reports.
• Review Quality Agreement and batch release documents.
• Request stability and impurity profiles.
• Confirm supplier’s capacity for continuous supply and contingency plans.
• Evaluate past regulatory inspections and compliance history.

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Supply Chain Challenges and Solutions

• Intellectual Property & Licensing: Given the proprietary nature of omidenepag isopropyl, ensure licensing agreements are in place before engaging API sources.
• Complex Synthesis & Cost: Its complex synthesis demands high-quality raw materials and catalysts, potentially impacting cost and lead times.
• Quality Variability: Establish rigorous testing protocols and supplier audits to mitigate batch inconsistency risks.

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Future Outlook

As omidenepag isopropyl advances toward broader clinical and commercial applications, API sourcing is expected to evolve:

• Emergence of dedicated API manufacturing facilities close to end-markets to reduce logistical risks.
• Increased partnerships with CMOs specializing in prostaglandin derivatives.
• Adoption of predictive analytics and real-time quality monitoring for supply chain optimization.
• Potential for synthesis process innovations to streamline production and reduce costs.

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Conclusion

Reliable sourcing of omidenepag isopropyl API encompasses a mix of established pharmaceutical manufacturers, contract synthesis specialists, and regional API providers. Enterprises must prioritize quality assurance, regulatory compliance, and supply chain robustness. Strategic partnerships and rigorous supplier qualification are essential for continuous, high-quality API procurement.

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Key Takeaways

• Regulatory compliance and quality assurance are critical when selecting API suppliers for omidenepag isopropyl.
• Leading CMOs like Lonza, WuXi, and Boehringer Ingelheim have the capabilities for complex organic API synthesis, including prostaglandin derivatives.
• Emerging regional manufacturers in Asia-Pacific may offer cost advantages but require thorough validation.
• Licensing arrangements and intellectual property protections must be clarified to ensure legal and uninterrupted supply.
• Supply chain resilience involves multi-source qualification, contingency planning, and ongoing quality audits.

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FAQs

1. Is there a single supplier for omidenepag isopropyl API?
No. Due to the complexity and proprietary nature, multiple suppliers across regions are involved, with licensing agreements often dictating specific sources.

2. What are the primary quality standards for sourcing omidenepag isopropyl?
Suppliers must comply with cGMP regulations, provide regulatory documentation (e.g., batch records, stability data), and meet pharmacopeial standards where applicable.

3. How does regional regulation impact API sourcing for omidenepag isopropyl?
Regulatory standards like FDA, EMA, and WHO influence supplier qualification, documentation, and batch certification requirements, affecting supply chain decisions.

4. What are common challenges in sourcing omidenepag isopropyl API?
Challenges include complex synthesis, intellectual property restrictions, ensuring consistent high purity, and managing supply chain disruptions.

5. Are there any upcoming innovations that will influence API sourcing?
Process innovations like scalable synthesis improvements and regional manufacturing hubs are anticipated to enhance availability and reduce costs.

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Sources

[1] U.S. Patent No. 10521947B2, illustrating synthetic routes for prostaglandin analogs.
[2] Pharmaceutical supplier affidavits and cGMP compliance reports, as obtained from vendor disclosures.
[3] Industry reports on ophthalmic API manufacturing trends, published by IQVIA and other market research firms.