Bulk Pharmaceutical API Sources for DOXYCYCLINE CALCIUM

Bulk Pharmaceutical API Sources for DOXYCYCLINE CALCIUM

Vendor	Vendor Homepage	Vendor Sku	API Url
AK Scientific, Inc. (AKSCI)		Y1767
Alfa Chemistry		94088-85-4
001Chemical		DY581428
Alfa Chemistry		ACM94088854

Bulk Active Pharmaceutical Ingredient (API) Sources for Doxycycline Calcium

Last updated: August 2, 2025

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Introduction

Doxycycline calcium is a broad-spectrum tetracycline antibiotic widely utilized for treating bacterial infections such as respiratory tract infections, urinary tract infections, and sexually transmitted diseases. As a pivotal component of numerous pharmaceutical formulations, the quality, consistency, and regulatory compliance of its Active Pharmaceutical Ingredient (API) are critical for manufacturer success and patient safety. This article provides a detailed overview of the global sources for bulk doxycycline calcium API, emphasizing the key suppliers, geographical distribution, regulatory considerations, and market dynamics vital for stakeholders in the pharmaceutical supply chain.

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Understanding Doxycycline Calcium API

Doxycycline calcium is the calcium salt form of doxycycline, which enhances stability and solubility characteristics advantageous for pharmaceutical formulation [1]. The API's synthesis involves complex chemical steps requiring stringent quality controls, and the API's source directly influences the drug's efficacy and safety profile.

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Major Global API Suppliers for Doxycycline Calcium

1. China: The Leading Source

China dominates the doxycycline calcium API market, accounting for a substantial share of global production. Major Chinese pharmaceutical active ingredient manufacturers include:

• Shenzhen Sonyee Biotechnology Co., Ltd.
  Recognized for high-volume production compliant with regulatory standards, the company supplies doxycycline calcium API to global markets, emphasizing high purity and consistent batch quality.

• Hanghai Zhiyuan Pharmaceutical Co., Ltd.
  Specializing in antibiotic APIs, this manufacturer offers doxycycline calcium with rigorous quality assurance aligned with GMP standards and export certifications.

• Jiangxi Haisi Pharmaceutical Co., Ltd.
  Known for a comprehensive portfolio of tetracycline derivatives, the firm exports doxycycline calcium primarily to Asian, African, and Latin American markets.

Chinese manufacturers benefit from cost advantages and rapid scalability; however, regulatory compliance and quality control remain critical for international customers seeking to meet strict pharmacopeial standards.

2. India: Growing Market and Reliable Quality

India has established itself as a significant API manufacturer with increasing compliance to international standards such as WHO cGMP and USFDA approvals. Notable Indian API producers include:

• Chemcon Speciality Chemicals Ltd.
  Known for stringent quality management, Chemcon supplies doxycycline calcium API globally, emphasizing USP and EP standards.

• Gujarat Leucon Technologies Pvt. Ltd.
  Offers doxycycline calcium API with certifications suitable for export to regulated markets, backed by impeccable quality controls.

Indian API companies benefit from a well-developed infrastructure, cost-competitiveness, and regulatory acumen, especially for markets with stringent quality and GMP requirements.

3. European and North American Sources

While Europe and North America traditionally import doxycycline calcium API, some manufacturers produce high-quality APIs compliant with USFDA, EMA, and other global standards.

• Hellenic Pharmacopoeia-approved producers (e.g., Teva Pharmaceuticals, Mylan)
  These companies may produce doxycycline calcium APIs domestically or through strategic partnerships, although their production volume tends to be lower than Asian suppliers.

The focus in these regions is on high-quality APIs with rigorous validation and documentation, primarily supporting formulations for highly regulated markets within Europe and North America.

4. Other Asian Markets

Countries like Vietnam, South Korea, and Sri Lanka host emerging API manufacturing capacities, offering competitive alternatives with increasing regulatory acceptance.

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Regulatory Landscape and Quality Certifications

API suppliers must adhere to stringent standards such as:

• GMP compliance: Mandatory for API manufacturing destined for international markets.
• Certifications: USFDA, EMA, WHO PQ, and ISO certifications verify manufacturing quality.
• Analytical validation: Suppliers must demonstrate API purity, potency, residual solvents, heavy metals, and microbiological standards aligning with pharmacopeial monographs (USP, EP, JP).

Manufacturers with recognized quality credentials are more likely to secure long-term supply contracts, especially in highly regulated markets.

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Market Dynamics and Sourcing Considerations

• Cost vs. Quality Trade-offs: Chinese manufacturers often offer competitive pricing but may present challenges related to meeting strict regulatory standards; Indian producers tend to strike a workable balance.
• Supply Chain Reliability: Diversification of sources mitigates risks, ensuring consistent supply amid geopolitical or regulatory disruptions.
• Lead Times and MOQ: Larger suppliers typically offer shorter lead times and scalable MOQ, critical for large production volumes.
• Regulatory Compliance: Buyers must ensure the API's documentation aligns with pharmacopoeial standards and regulatory authority requirements of their target markets.
• Sustainability and Ethical Manufacturing: Emerging expectations emphasize environmentally sustainable practices and fair labor standards.

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Strategic Implications for Pharmaceutical Companies

Manufacturers sourcing doxycycline calcium API should prioritize suppliers with proven regulatory compliance, consistent quality, and reliable supply chains. Developing relationships with multiple qualified suppliers mitigates regional risks and sustains manufacturing continuity. Additionally, ongoing due diligence, including supplier audits and analytical validation, is essential in maintaining product quality and regulatory compliance.

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Conclusion

The global landscape for doxycycline calcium API sourcing is characterized by dominant suppliers from China and India, with increasing quality standards and regulatory certifications shaping the competitive environment. Strategic sourcing requires balancing cost, quality, regulatory compliance, and supply chain reliability. A meticulous supplier assessment process and diversification strategy are vital to ensuring uninterrupted supply for pharmaceutical formulations, ultimately safeguarding patient health and maintaining market competitiveness.

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Key Takeaways

• China remains the largest producer of doxycycline calcium API, offering cost-effective options but requiring careful regulatory validation.
• India is gaining prominence as a reliable source, with suppliers meeting international quality standards suitable for regulated markets.
• Regulatory compliance and certifications—such as GMP, USFDA, and WHO PQ—are fundamental for API supplier credibility and market acceptance.
• Diversification of sources minimizes supply disruptions, especially amid geopolitical or trade-related uncertainties.
• Due diligence and continuous supplier evaluation are crucial for maintaining quality standards and compliance in global API sourcing.

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FAQs

1. What are the key factors to consider when sourcing doxycycline calcium API?
Quality certifications, regulatory compliance, supplier reputation, supply chain stability, cost, and adherence to pharmacopeial standards.

2. Which countries dominate the doxycycline calcium API market?
China and India are the primary producers, with emerging capacities in Southeast Asia and regulated markets in Europe and North America.

3. How does regulatory compliance affect API sourcing choices?
Regulatory compliance ensures API acceptability for regulated markets, prevents delays, and reduces compliance risks, necessitating suppliers with GMP certification and recognized quality standards.

4. Are there risks associated with sourcing from China?
Potential risks include variability in quality, regulatory barriers, and intellectual property concerns. These can be mitigated through quality audits and selecting suppliers with international certifications.

5. How can pharmaceutical companies diversify their doxycycline calcium API supply chain?
By establishing relationships with multiple qualified suppliers across different regions, conducting ongoing quality assessments, and maintaining strategic inventories to buffer against disruptions.