Bulk Pharmaceutical API Sources for oxytetracycline calcium

Bulk Pharmaceutical API Sources for oxytetracycline calcium

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		YhRTI@@Mg`AC@djfcklbbbbbbbvfdSbLRTTxtT|\JFfZAhJhjjZZfjJXxmFq\bhZ@@
NovoSeek		5280972
MolPort		MolPort-002-524-946
Hangzhou APIChem Technology		AC-12777
ABI Chem		AC1L1MWD
ABI Chem		AC1NQXTY

Bulk Active Pharmaceutical Ingredient (API) Sources for: Oxytetracycline Calcium

Last updated: July 27, 2025

Introduction

Oxytetracycline calcium, a broad-spectrum antibiotic belonging to the tetracycline class, is extensively employed in veterinary medicine and livestock industries. Due to its widespread usage, sourcing high-quality bulk API is critical for pharmaceutical manufacturers, veterinary drug developers, and related supply chain stakeholders. This article explores global API manufacturers, geopolitical considerations, quality standards, regulatory environments, and market dynamics influencing the procurement of oxytetracycline calcium.

Global API Manufacturers of Oxytetracycline Calcium

Major API Producers

The primary API manufacturing landscape for oxytetracycline calcium features a handful of well-established companies predominantly based in India, China, and Europe. These regions have developed robust pharmaceutical chemical sectors capable of producing high-quality APIs at scale, aligned with international standards such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and other relevant certifications.

1. India-Based Manufacturers

India remains a dominant source of oxytetracycline calcium due to its expansive bulk chemical manufacturing capacity and cost-competitiveness. Notable players include:

• Strides Pharma Science Ltd.: Known for its integrated pharmaceutical manufacturing, Strides produces various tetracycline antibiotics, including oxytetracycline calcium, adhering to cGMP standards.

• Macleods Pharmaceuticals: Offers bulk API supply for a range of antibiotics, including oxytetracycline calcium, catering to global markets.

• Aurobindo Pharma: Recognized for its extensive API portfolio, including tetracycline derivatives, with multiple manufacturing units compliant with GMP standards.

2. China-Based Manufacturers

China remains a significant API supplier, leveraging its large-scale chemical manufacturing infrastructure:

• North China Pharmaceutical Group Corporation (NCPC): Supplies various tetracycline APIs, including oxytetracycline calcium, with a focus on export markets.

• Zhejiang Hisun Pharmaceutical: An integrated pharmaceutical company with capabilities to produce multiple tetracycline antibiotics, maintaining compliance with international standards.

• Huabo Chemical: Offers bulk APIs, including oxytetracycline calcium, with a focus on affordability and volume.

3. European Manufacturers

European firms tend to focus on higher-quality, cGMP-compliant APIs, often serving the US and European markets through stringent quality controls:

• VWR International: Distributes laboratory-grade APIs, including oxytetracycline calcium, sourced globally from qualified manufacturers.

• Pharmaceutical grade API suppliers from Germany and France: Some boutique producers and contract manufacturers provide high purity APIs adhering to strict regulatory requirements.

Market Dynamics and Sourcing Considerations

Supply Chain Complexity

The supply chain for oxytetracycline calcium involves raw material procurement, synthesis, purification, and strict quality control measures. The complexity increases with the need for API stability, bioavailability, and compliance with pharmacopeial standards.

Quality Assurance and Regulatory Compliance

When sourcing oxytetracycline calcium APIs, companies prioritize suppliers with demonstrated adherence to cGMP, ISO standards, and relevant pharmacopeias. The risks associated with substandard APIs include product recalls, patent infringements, and regulatory sanctions.

Third-party testing, certifications, and audit reports form the backbone of due diligence processes. Notably, some jurisdictions require batch-specific certificates of analysis (CoA) and stability data to ensure batch-to-batch consistency.

Regulatory Environment and Market Access

The regulatory landscape significantly influences API sourcing strategies:

• United States: The FDA enforces strict cGMP standards; APIs must be sourced from approved facilities or undergo rigorous validation.

• European Union: EFSA and EMA regulations specify strict quality requirements, often favoring European or approved third-party suppliers.

• India and China: Several companies have achieved WHO-GMP and USFDA approval, enabling exports to regulated markets. However, variability exists, necessitating thorough quality vetting.

Emerging Trends & Market Shifts

• Manufacturing Consolidation: Larger firms acquiring smaller API producers aim to streamline quality control and reduce costs.

• Regulatory Tightening: Enhanced scrutiny leads to increased validation requirements, influencing sourcing from certified facilities.

• Supply Chain Resilience: COVID-19 exposed vulnerabilities in supply chains; diversified sourcing strategies are increasingly adopted.

• Environmental & Sustainability Standards: Growing emphasis on green chemistry prompts API manufacturers to upgrade technologies, influencing sourcing preferences.

Strategic Sourcing Recommendations

• Prioritize FDA- and EMA-Approved Suppliers: Ensures compliance with the most rigorous standards.

• Evaluate Manufacturing Track Record: Consider supplier audit reports, batch consistency records, and certification status.

• Diversify Suppliers: Reduce risk associated with geopolitical issues, pandemics, and regulatory changes.

• Engage in Early Dialogue: Maintain ongoing communication with suppliers regarding quality, lead times, and regulatory updates.

Conclusion

The bulk sourcing landscape for oxytetracycline calcium API is characterized by a few dominant regions and an evolving regulatory environment. Indian and Chinese manufacturers continue to be the primary suppliers due to their large-scale production capacity and cost advantages, with European suppliers positioning as high-quality alternatives aligned with stringent standards. A strategic approach to procurement involves rigorous supplier qualification, adherence to regulatory standards, and diversification to mitigate supply chain risks.

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Key Takeaways

• India and China are primary sources for bulk oxytetracycline calcium, offering cost-effective solutions with varying regulatory compliance levels.

• European suppliers predominantly serve high-regulatory markets, emphasizing quality and traceability.

• Due diligence—including certifications such as cGMP and ISO—is critical to ensure API quality and regulatory compliance.

• Supply chain resilience is increasingly prioritized, leading to diversification of sources and supplier relationships.

• Environmental standards and regulatory tightening influence manufacturing practices and supplier selection.

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FAQs

1. What are the main factors influencing API quality for oxytetracycline calcium?
Quality factors include adherence to cGMP standards, purity certifications, batch-to-batch consistency, stability data, and compliance with pharmacopeial specifications.

2. Which countries are the most reliable sources of oxytetracycline calcium API?
The United States (through approved suppliers), European Union, India, and China are prominent sources, with India and China leading in raw volume and cost efficiency.

3. How can companies mitigate risks in sourcing oxytetracycline calcium APIs?
By diversifying suppliers, conducting thorough audits, verifying certifications, establishing long-term relationships, and maintaining contingency stockpiles.

4. Are regulatory approvals necessary for importing oxytetracycline calcium APIs?
Yes. For markets like the US and EU, APIs must originate from approved, validated suppliers compliant with relevant regulations (e.g., FDA approval, EMA certification).

5. What future trends could impact the oxytetracycline calcium API market?
Enhanced regulatory scrutiny, environmental sustainability practices, technological innovations in manufacturing, and geopolitical factors could reshape sourcing strategies.

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Sources

[1] U.S. Food and Drug Administration (FDA). "API Product Approval and Compliance."
[2] World Health Organization (WHO). "Prequalification of Medicines Program."
[3] European Medicines Agency (EMA). "Guidelines on Good Manufacturing Practice."
[4] Market intelligence reports on API manufacturing (e.g., IQVIA, PharmSource).
[5] Industry publications and company press releases.