Bulk Pharmaceutical API Sources for SEYSARA

Bulk Pharmaceutical API Sources for SEYSARA

Vendor	Vendor Homepage	Vendor Sku	API Url
Acesobio		cc-302
A2Z Chemical		AZM14395
ZINC		ZINC72319783
ChemShuttle		104918

Bulk Active Pharmaceutical Ingredient (API) Sources for SEYSARA

Last updated: July 29, 2025

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Introduction

SEYSARA (tartrazine) is an FDA-approved medication primarily used for the treatment of bacterial infections in animals, including skin infections and pneumonia. As an animal health solution, its manufacturing relies on the sourcing of high-quality Active Pharmaceutical Ingredients (APIs). A robust, reliable API supply chain is crucial to ensure consistency, efficacy, and compliance with regulatory standards. This article examines the global landscape of bulk API suppliers pertinent to SEYSARA’s active compound, highlighting key players, sourcing considerations, and market trends.

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Understanding the API Composition of SEYSARA

SEYSARA contains the active ingredient tulathromycin, a macrolide antibiotic effective against a broad spectrum of bacterial pathogens in veterinary medicine. The therapeutic efficacy of SEYSARA hinges on the consistent quality of tulathromycin APIs procured from reputable suppliers operating under Good Manufacturing Practices (GMP).

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Global API Manufacturing Landscape for Tulathromycin

1. Major API Producers

The supply chain for tulathromycin APIs is concentrated among a handful of specialized manufacturers, primarily located in regions with established pharmaceutical manufacturing capabilities such as North America, Europe, and Asia.

• United States: Several biotech and pharmaceutical firms specializing in veterinary APIs operate within the U.S. market, benefiting from strict regulatory oversight and advanced R&D infrastructure.
• Europe: European-based manufacturers often supply APIs adhering to EU GMP standards, serving both local and international markets.
• Asia (China and India): The region's robust API manufacturing sector is characterized by high-volume, cost-competitive facilities, some of which produce veterinary APIs under stringent quality controls.

2. Leading API Suppliers for Tulathromycin

While specific API manufacturers often operate as confidential entities, publicly available information indicates the following key players:

• North American Biotech Firms: Several pharmaceutical companies specializing in veterinary medicines manufacture or source tulathromycin APIs domestically, including companies like Zoetis, which developed SEYSARA.

• Chinese API Manufacturers: Companies such as Zhejiang Hailir Pharmaceutical Co., Ltd. and Sichuan Yuanda Biotechnology Co., Ltd. are prominent in large-scale API synthesis, including macrolide antibiotics. These firms supply both the domestic Chinese market and international buyers, often under rigorous quality standards.

• Indian API Manufacturers: Enterprises like Grand Pharma and Aarti Drugs produce various antibiotics, including macrolides suitable for veterinary applications. Their APIs often undergo third-party verification to meet global standards.

3. Contract Manufacturing and Sourcing Strategies

Farmaceutical companies frequently partner with Contract Manufacturing Organizations (CMOs) that specialize in API synthesis:

• CMOs in India and China: Offer scalable, cost-effective API production with compliance to international quality standards. Leading CMOs, such as Biocon and Jubilant Life Sciences, are known for producing veterinary APIs.
• Vertical Integration: Some pharmaceutical firms, including Zoetis, integrate API production with finished formulation manufacturing to ensure supply chain integrity.

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Regulatory Considerations

API sourcing for veterinary medicines like SEYSARA necessitates adherence to:

• GMP compliance: Ensures API quality, purity, and safety.
• Regulatory approvals: APIs must meet regulatory standards from agencies such as the FDA (U.S.), EMA (Europe), and comparable bodies in other jurisdictions.

Manufacturers often possess certifications such as ISO 9001, and APIs are subject to rigorous testing processes including HPLC purity analysis, endotoxin testing, and stability assessments.

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Market Trends and Future Outlook

• Rising Demand for Veterinary APIs: The global veterinary pharmaceuticals market is expanding, driven by increased pet ownership and livestock health management, amplifying demand for APIs like tulathromycin.
• Supply Chain Diversification: Manufacturers and pharmaceutical companies are increasingly diversifying API sources to mitigate risks related to geopolitical issues, trade tariffs, and supply disruptions.
• Technological Advancements: Innovations in synthetic pathways and process optimization are improving API yields, reducing costs, and enhancing purity.
• Regulatory Stringency: Stricter international regulations are compelling API suppliers to upgrade manufacturing standards and transparency, fostering a safer supply chain.

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Conclusion

The procurement of high-quality tulathromycin API is critical in the manufacturing of SEYSARA. Major sourcing regions include North America, Europe, and Asia, with China and India emerging prominently due to their extensive, cost-effective production capacities. Ensuring API accreditation under GMP standards and confirming regulatory compliance are paramount for maintaining product integrity. As the veterinary pharmaceutical market evolves, diversification and technological innovation will remain key drivers influencing API sourcing strategies.

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Key Takeaways

• Global sourcing is integral for ensuring a reliable supply chain of tulathromycin APIs for SEYSARA.
• Major API suppliers include North American biotech firms, Chinese and Indian API manufacturers, and CMOs specializing in veterinary antibiotics.
• Regulatory compliance and quality assurance are non-negotiable to meet FDA, EMA, and other international standards.
• Market dynamics, including growing demand and geopolitical factors, influence strategic sourcing decisions.
• Ongoing innovations enhance API efficiency, quality, and cost-effectiveness, benefiting veterinary pharmaceuticals manufacturers.

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FAQs

Q1: What are the primary regions supplying tulathromycin APIs for SEYSARA?
A1: The main regions are North America, Europe, China, and India, with China and India providing the bulk of cost-competitive APIs.

Q2: How do regulatory standards impact API sourcing for veterinary medicines like SEYSARA?
A2: APIs must be produced under GMP conditions and approved by relevant authorities such as the FDA or EMA to ensure safety, efficacy, and quality.

Q3: Are Chinese and Indian API manufacturers reliable sources for tulathromycin?
A3: Yes, many comply with international standards and hold certifications; however, due diligence and third-party audits are recommended before procurement.

Q4: What role do Contract Manufacturing Organizations play in API sourcing?
A4: CMOs facilitate large-scale, compliant API production, enabling pharmaceutical companies to diversify risk and optimize costs.

Q5: How might future market trends influence API sourcing strategies for veterinary drugs like SEYSARA?
A5: Increased regulation, technological advances, and supply chain diversification will shape sourcing strategies toward higher standards and risk mitigation.

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References

1. FDA. (2022). Veterinary Medicine Regulations and Standards. U.S. Food & Drug Administration.
2. European Medicines Agency. (2022). Guidelines on Veterinary Medicine Manufacturing. EMA.
3. Market Research Future. (2023). Global Veterinary Antibiotics Market Analysis.
4. Journals of Veterinary Pharmacology. (2021). Synthesis and Quality Control of Veterinary Macrolides.
5. API Manufacturer Websites. (Accessed 2023). Data on API certifications and manufacturing capacities.

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This comprehensive overview aims to empower stakeholders involved in the sourcing and manufacturing of SEYSARA by elucidating the global API landscape and associated strategic considerations.