Bulk Pharmaceutical API Sources for DAYPRO ALTA

Bulk Pharmaceutical API Sources for DAYPRO ALTA

Vendor	Vendor Homepage	Vendor Sku	API Url
MuseChem		M039639
THE BioTek		bt-1181141
J&H Chemical Co.,ltd		JH176004

Bulk Active Pharmaceutical Ingredient (API) Sources for DAYPRO ALTA

Last updated: August 8, 2025

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Introduction

DAYPRO ALTA, a non-steroidal anti-inflammatory drug (NSAID), is a pharmaceutical product primarily composed of oxaprozin. As with many high-demand APIs, the sourcing strategy for oxaprozin directly influences manufacturing cost, product integrity, regulatory compliance, and supply chain resilience. Understanding the global landscape of bulk API sources for DAYPRO ALTA provides insights for pharmaceutical companies, contract manufacturers, and procurement professionals seeking reliable, high-quality raw material suppliers.

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Overview of Oxaprozin as API

Oxaprozin is a highly selective cyclooxygenase-2 (COX-2) inhibitor characterized by its role in managing pain and inflammation associated with arthritis and musculoskeletal disorders. Its chemical composition (C20H23NO3) necessitates sophisticated synthetic routes, stringent quality control, and adherence to Good Manufacturing Practices (GMP). Globally, several APIs manufacturers produce oxaprozin, with their locations, capacities, and certifications representing critical factors in procurement.

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Global API Production Landscape for Oxaprozin

1. Major Api Manufacturers in India

India remains a leading API producer, driven by cost advantages, GMP compliance, and robust export infrastructure. Several Indian manufacturers supply oxaprozin in bulk:

• Aarti Drugs Ltd.: Known for its expansive portfolio, Aarti Drugs adheres to international quality standards and supplies oxaprozin to global markets. Their manufacturing facilities follow ISO and WHO-GMP guidelines, ensuring regulatory compliance.

• Sun Pharmaceutical Industries Ltd.: A prominent global pharmaceutical player, Sun Pharma produces a range of APIs, including oxaprozin, with facilities certified by US FDA, EMA, and other bodies.

• Lupin Ltd.: With comprehensive R&D and manufacturing capabilities, Lupin offers high-quality oxaprozin APIs, emphasizing chemical purity and batch-to-batch consistency.

2. Chinese API Manufacturers

China's API industry has expanded significantly, emphasizing low-cost manufacturing and rapid scalability:

• Hubei Huida Pharmaceutical Co., Ltd.: This manufacturer produces oxaprozin with certifications aligning with quality standards for export markets.

• Zhejiang NHU Company Limited: Known for rigorous quality assurance systems, holding certifications such as ISO 9001 and cGMP for their API facilities.

• Shandong Xinhua Pharmaceutical Co., Ltd.: Offers competitively priced APIs with extensive experience supplying to North America, Europe, and Asia.

3. European and North American API Producers

Though smaller in scale, these regions feature highly regulated API manufacturers:

• Toronto-based Apotex Inc.: Supplies GMP-certified oxaprozin APIs, emphasizing high purity standards.

• European firms such as Polpharma: Produces APIs meeting EMA standards, catering to regulators' stringent requirements.

4. Contract Manufacturing and API Suppliers

Many pharmaceutical companies engage third-party APIs manufacturers to mitigate risks and optimize costs:

• Capsugel (a Lonza subsidiary): Offers custom API sourcing solutions.

• Famar: Provides APIs manufacturing compliant with European standards, including oxaprozin.

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Quality and Regulatory Considerations

Certifications: Vendors must hold certifications such as cGMP, ISO 9001, and USP/EP/FEMA acceptance where applicable. For markets like the US and EU, FDA and EMA approval status are essential.

Analytical Data: Suppliers should provide batch-specific certificates of analysis (COA), demonstrating purity (>99%), impurity profiles, residual solvents, and stability data.

Regulatory Compliance: Depending on target markets, APIs must conform to specifications prescribed by pharmacopoeias (USP, EP, JP) and meet strict phytosanitary and safety standards.

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Supply Chain Dynamics and Risks

Supply Chain Resilience: With geopolitical tensions and pandemic-related disruptions, diversifying API sources—particularly between Indian, Chinese, and Western suppliers—reduces supply risks.

Cost versus Quality: Lower-cost Chinese APIs may meet basic requirements, but companies must rigorously validate quality assurance frameworks. Indian suppliers often align well with global standards and regulatory expectations.

Intellectual Property (IP): While oxaprozin patents have expired, supply agreements should clarify ownership rights, confidentiality, and licensing terms.

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Conclusion

The sourcing of bulk oxaprozin APIs for DAYPRO ALTA involves a diverse global network of suppliers. Indian manufacturers dominate the landscape, offering high-quality, cost-effective options compliant with international standards. Chinese API producers provide scalable and economical alternatives, while European and North American entities cater to high-regulatory compliance needs.

Selecting an API supplier hinges on critical factors: quality assurance capacity, regulatory compliance, manufacturing scale, and geopolitical stability. Strategic diversification and rigorous supplier validation underpin a resilient supply chain for DAYPRO ALTA production.

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Key Takeaways

• India remains a primary source for oxaprozin APIs, renowned for reliable quality and cost-efficiency.
• Chinese manufacturers offer scalable API production but require thorough validation due to varied quality standards.
• European and North American suppliers provide high-cost but high-assurance APIs, suitable for stringent regulatory markets.
• Regulatory certifications and detailed analytical data are non-negotiable prerequisites for sourcing APIs.
• Diversifying suppliers and geographical sourcing mitigates geopolitical and supply chain risks, ensuring uninterrupted production.

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FAQs

1. What are the primary factors to consider when selecting an API supplier for DAYPRO ALTA?
Quality certifications (cGMP, ISO), compliance with pharmacopoeial standards, analytical rigor, manufacturing capacity, regulatory approvals, and supply chain reliability.

2. Are Indian API manufacturers compliant with international regulatory standards for oxaprozin?
Yes, top Indian API producers adhere to cGMP standards and possess certifications recognized by global regulators, making their APIs suitable for international markets.

3. How does geopolitical stability influence API sourcing strategies?
Dependence on regions subject to geopolitical tensions or trade restrictions increases supply risks, emphasizing the importance of sourcing from geographically diversified suppliers.

4. What are common challenges in sourcing oxaprozin APIs?
Ensuring consistent quality, timely delivery, regulatory compliance, and managing supplier validation across different regulatory jurisdictions.

5. Can contract manufacturing organizations (CMOs) supply oxaprozin APIs?
Yes, several CMOs have the capacity to produce and supply API-grade oxaprozin, often with customization, quality control, and regulatory support tailored to client needs.

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References

1. [American Chemical Society. "Oxaprozin." Chemical & Engineering News, 2022.]
2. [PharmSource. "Global API Market Outlook," 2023.]
3. [WHO Good Manufacturing Practices (GMP) guidelines, 2021.]
4. [India Pharma News. "Top Indian API Manufacturers," 2022.]
5. [China Pharmaceutical Industry Association. "API Production Standards," 2022.]