Bulk Pharmaceutical API Sources for suprofen

Bulk Pharmaceutical API Sources for suprofen

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		jdyAb@FAb@HrQQJVIKJJDihuRl@ESP@@
NovoSeek		5359
MolPort		MolPort-001-791-811

Bulk Active Pharmaceutical Ingredient (API) Sources for: Suprofen

Last updated: July 29, 2025

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Introduction

Suprofen, a non-steroidal anti-inflammatory drug (NSAID), was initially synthesized in the 1970s and is primarily employed as an ophthalmic solution to treat inflammation following ocular surgery. Although its systemic applications diminished due to safety concerns, the API remains relevant in certain formulations. Reliable bulk sourcing of Suprofen is essential for pharmaceutical companies aiming to manufacture ophthalmic and other specialized formulations. This article offers a comprehensive overview of synthetic routes, primary API suppliers, and considerations for sourcing Suprofen in bulk.

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Chemical Profile of Suprofen

Suprofen is chemically known as (±)-4'-[(3-Methyl-2-benzofuranyl)carbonyl]phenylacetic acid. Its molecular weight is approximately 274.3 g/mol. Structurally characterized by a benzofuran derivative linked to phenylacetic acid, Suprofen’s synthesis involves complex aromatic substitution and oxidation steps, often demanding high-purity manufacturing processes to meet pharmaceutical standards.

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Synthetic Pathways to Suprofen

The synthesis of Suprofen typically involves multiple steps:

• Furanyl Derivative Preparation: Construction of the benzofuran core through cyclization reactions involving 2-alkynylphenols.

• Acylation and Substitution: Attachment of the phenylacetic acid moiety using acylation techniques.

• Purification & Crystallization: Ensuring high purity via crystallization, critical to meet API specifications.

Manufacturers adhere to stringent cGMP standards, employing advanced synthetic methodologies to optimize yield, purity, and stability ([2]).

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Leading API Suppliers for Suprofen

Given its relatively niche status, the bulk supply of Suprofen is concentrated among specialized chemical and pharmaceutical manufacturers. The following are among the most prominent sources:

1. Chinese Pharmaceutical Manufacturers

China remains a dominant source of various NSAID APIs, including Suprofen. Several GMP-certified factories specialize in aromatic and NSAID molecule synthesis:

• Zhejiang Chemsino Pharmaceutical: Offers high-quality Suprofen APIs complying with international standards, focused on ophthalmic-grade formulations.

• Shandong Xinhua Pharmaceutical: Provides bulk Suprofen with assured bioequivalence, often supplying to global APIs distributors.

2. Indian API Producers

India's pharmaceutical industry, known for cost-effective manufacturing, includes firms with capabilities for NSAID synthesis:

• Sun Pharmaceutical Industries Ltd.: Has capabilities for complex NSAID APIs; specific production of Suprofen reported, ensuring pharmaceutical-grade quality.

• Aarti Drugs Ltd.: Supplies variety of NSAID APIs, including potentially Suprofen, for both domestic and export markets.

3. European Specialists

While European suppliers are more focused on formulations, some niche chemical companies produce and export pharmaceutical-grade API:

• BASF (Germany): Known for custom synthesis services; may produce Suprofen under contract manufacturing arrangements, emphasizing strict quality control.

• Evonik Industries: Provides specialty chemicals, potentially including custom synthesis of NSAID-related APIs.

4. US-Based API Manufacturers

Due to regulatory rigor, US firms producing Suprofen are limited:

• Carbogen-Amcis: Focuses on complex API synthesis; potential supplier for custom Suprofen synthesis following client specifications.

5. Contract manufacturing organizations (CMOs)

Numerous CMOs globally can synthesize Suprofen on a contract basis, often catering to pharmaceutical companies seeking small to large batch production with compliant quality standards.

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Selection Considerations for API Sourcing

When choosing a Suprofen API supplier, several factors merit assessment:

• Regulatory Compliance: Ensure supplier adheres to cGMP standards and possesses relevant certifications (e.g., EDQM Certification, FDA registration).

• Purity & Quality Standards: Verify specifications, including HPLC purity (>99%), residual solvents, heavy metals, and microbial limits.

• Supply Capacity & Lead Time: Confirm manufacturing capacity aligns with demand forecasts and delivery schedules.

• Pricing & Payment Terms: Evaluate cost-effectiveness without compromising quality.

• Traceability & Documentation: Ensure adequate batch documentation, stability data, and supply chain transparency.

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Market Outlook & Challenges

Despite Suprofen's diminished systemic use, ophthalmic formulations continue to sustain demand in specific regions. The complexity of its synthesis and regulatory hurdles pose challenges:

• Limited Supplier Base: The niche API's specialized production limits market competition, potentially affecting pricing.

• Regulatory Barriers: Strict quality control requirements can restrict entry for new suppliers.

• Supply Chain Disruptions: Global logistics issues impact timely procurement, especially from regions with less mature supply chains.

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Regulatory and Quality Assurance

Suppliers must demonstrate adherence to international pharmacopoeias such as USP, EP, or JP. Validation of raw material sourcing, in-process controls, and final product testing are mandatory. Integrating robust quality assurance frameworks ensures API safe and compliant for pharmaceutical manufacturing ([3]).

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Emerging Trends and Alternatives

• Synthetic Innovation: Advances in green chemistry techniques aim to reduce hazardous reagents and improve yields for Suprofen synthesis.

• Alternative NSAIDs: Given safety profiles or patent considerations, some manufacturers pivot to alternatives with similar anti-inflammatory efficacy.

• Regional Sourcing: Localized API sourcing reduces dependency on long supply chains, especially pertinent amid global disruptions.

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Conclusion

Sourcing bulk Suprofen API requires diligence due to its niche status and technical synthesis complexity. Reputable Chinese and Indian manufacturers currently dominate the supply landscape, providing high-quality, cost-effective options. Pharmaceutical companies should prioritize suppliers with robust regulatory compliance, verified purity standards, and reliable delivery records. As demand persists in ophthalmic applications, emerging synthetic innovations and regional sourcing may further influence market dynamics.

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Key Takeaways

• Established suppliers for Suprofen are predominantly based in China and India, offering cost-effective, high-quality APIs.
• Due diligence on regulatory compliance, purity standards, and supply capacity is critical for sourcing Suprofen.
• The synthesis of Suprofen involves complex aromatic chemistry, necessitating experienced manufacturing partners.
• Market demand remains niche but steady, driven by ophthalmic applications rather than systemic NSAID use.
• Emerging synthetic methods and regional sourcing strategies could impact future supply chains for Suprofen.

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FAQs

1. What are the main applications of bulk Suprofen APIs?
Primarily used in ophthalmic solutions to manage postoperative inflammation, with limited systemic applications due to safety concerns.

2. Are there alternative NSAID APIs to Suprofen for ophthalmic use?
Yes, alternatives such as Ketorolac and Diclofenac are also used in ophthalmic formulations, often with a more established safety profile.

3. How can I verify the quality of Suprofen sourced from offshore suppliers?
Require comprehensive certificates of analysis (CoA), batch records, and third-party testing reports confirming compliance with pharmacopeial standards.

4. What are the main challenges in sourcing Suprofen API?
Limited number of suppliers, complex synthesis, regulatory hurdles, and ensuring consistent purity and supply reliability.

5. Is Suprofen still under patent protection?
Suprofen’s original patents have expired; however, formulation patents may still influence its commercial production and availability.