Bulk Pharmaceutical API Sources for CALMURID HC

Bulk Pharmaceutical API Sources for CALMURID HC

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		174093
ABI Chem		AC1L5AU4
ChemTik		CTK2F3888
J&H Chemical Co.,ltd		JH419704

Bulk Active Pharmaceutical Ingredient (API) Sources for: CALMURID HC

Last updated: August 5, 2025

Introduction

The pharmaceutical industry relies on a resilient and reliable supply chain for active pharmaceutical ingredients (APIs) to ensure consistent drug manufacturing and compliance with regulatory standards. CALMURID HC, a prominent combination medication used primarily for treating inflammatory and allergic conditions, contains two key APIs: Hydroxyzine Hydrochloride (Hydroxyzine HCl) and Hydrocortisone. This article examines existing bulk API sources for CALMURID HC, evaluating manufacturer credibility, geographic distribution, regulatory status, and supply stability, providing business professionals with critical insights into sourcing strategies for these APIs.

Overview of CALMURID HC and its APIs

CALMURID HC combines Hydroxyzine Hydrochloride, an antihistamine with sedative properties, and Hydrocortisone, a corticosteroid. Its therapeutic application hinges on the synergistic effects of these APIs, necessitating high-quality, compliant bulk API sources to maintain product efficacy and safety standards.

Hydroxyzine Hydrochloride API Sources

Manufacturers and Suppliers

Hydroxyzine HCl synthesis predominantly involves complex complexation processes derived from phenothiazine derivatives. Leading API suppliers include:

• Amneal Pharmaceuticals: A reputable U.S.-based manufacturer providing high-grade Hydroxyzine HCl, known for its GMP compliance and robust supply chain.
• Sandoz (Novartis): A global generic pharmaceutical giant offering Hydroxyzine HCl, with production facilities certified under Good Manufacturing Practice (GMP) standards.
• Meyer Organics: An Indian API manufacturer producing Hydroxyzine HCl that adheres to domestic and international regulatory standards, including WHO GMP certifications.
• Zhejiang WH Biotech: Based in China, this company supplies Hydroxyzine HCl with increasing export volume, supported by robust quality systems compliant with ISO standards.

Regulatory and Quality Considerations

Suppliers such as Sandoz and Amneal are routinely inspected by regulatory agencies including the FDA and EMA, ensuring product quality and compliance. Indian and Chinese manufacturers, including Meyer Organics and Zhejiang WH Biotech, frequently seek cGMP and ISO certifications, enhancing their eligibility for global supply.

Supply Chain Dynamics

The global demand for Hydroxyzine HCl is influenced by the prevalence of allergic and inflammatory conditions. Manufacturers with diversified production facilities mitigate risks of supply disruptions. Recently, expanded capacity in Indian and Chinese API plants has improved API availability and cost competitiveness.

Hydrocortisone API Sources

Global Manufacturers

Hydrocortisone, a corticosteroid used for its anti-inflammatory properties, is widely produced by:

• Sandoz: A key supplier offering high-purity Hydrocortisone injections and APIs, with GMP-certified facilities.
• Capot Chemical: Based in China, supplying bulk Hydrocortisone API targeted at both domestic and international markets, with certifications including ISO and GMP.
• Jubilant Life Sciences: An Indian pharmaceutical manufacturer manufacturing Hydrocortisone API, meeting global regulatory standards.
• Novartis: Through longstanding manufacturing operations, sources Hydrocortisone with consistent quality assurances.

Regulatory and Quality Attributes

Suppliers with comprehensive GMP facilities, such as Sandoz and Jubilant, maintain robust documentation and stability data, critical for regulatory approval in target markets. Chinese manufacturers, while economically advantageous, must possess verified certifications to ensure quality and compliance.

Supply Chain Stability

Hydrocortisone’s extensive global manufacturing base enhances supply security. Capacity expansion in India and China has mitigated previous shortages, aligning with increased demand driven by corticosteroid therapy applications.

Supply Chain Considerations for CALMURID HC

Quality Assurance and Regulatory Compliance

An API source’s capacity to meet regulatory expectations in different markets is vital. Suppliers with established certifications (GMP, ISO, WHO GMP) facilitate faster registration and reduce compliance risks.

Cost and Lead Time

Cost considerations are influenced by geographic location, manufacturing scale, and certification status. Indian and Chinese suppliers often offer competitive pricing and flexible lead times but require thorough audits and quality verification.

Supply Security and Diversification

Relying solely on one API supplier exposes manufacturers to risks of shortages. Diversifying sources across approved vendors globally enhances resilience, especially amid geopolitical disruptions or pandemic-related manufacturing scale-up constraints.

Environmental and Ethical Standards

Manufacturers committed to sustainable practices and ethical sourcing, including reduction of environmental impact and fair labor practices, align with corporate social responsibility (CSR) goals and regulatory expectations.

Emerging Trends in API Sourcing

• Regulatory Harmonization: Increasing adoption of cGMP standards across emerging markets improves API quality globally.
• Supply Chain Digitization: Blockchain and advanced logistics tracking improve transparency and traceability.
• Biopharmaceutical Alternatives: Research into biosimilar APIs may influence traditional source strategies over the next decade.

Conclusion

The bulk API sourcing landscape for CALMURID HC involves a blend of established global manufacturers and emerging regional suppliers. Ensuring consistent quality, regulatory compliance, and supply security requires strategic diversification, rigorous supplier assessments, and ongoing monitoring of manufacturing capacities. Collaborating with certified suppliers such as Sandoz, Amneal, and Jubilant guarantees high-quality APIs, while leveraging capacity expansions in China and India optimizes cost and availability. This approach fortifies production stability amid fluctuating global supply dynamics, enabling pharmaceutical companies to meet steady demand with confidence.

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Key Takeaways

• Prioritize API suppliers with recognized certifications (GMP, ISO, WHO GMP) to ensure compliance.
• Diversify sourcing channels across different geographic regions to mitigate supply disruptions.
• Regularly monitor supply chain developments, especially capacity expansions in India and China.
• Incorporate comprehensive quality audits and certifications in vendor qualification processes.
• Leverage emerging technological trends to bolster transparency and supply chain resilience.

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FAQs

1. What are the primary global regions supplying Hydroxyzine Hydrochloride and Hydrocortisone APIs?
   North America, Europe, and India mainly supply Hydroxyzine HCl, with China and India leading Hydrocortisone production. Key suppliers include Sandoz, Amneal, Jubilant, and Zhejiang WH Biotech.

2. How do certifications impact API sourcing decisions?
   Certifications like GMP and ISO ensure manufacturing quality, regulatory compliance, and market acceptance, making certified suppliers preferred partners.

3. Are Chinese and Indian API manufacturers reliable sources for CALMURID HC?
   Yes, many Chinese and Indian suppliers have made significant advances in quality and regulatory compliance, especially those with verified GMP certifications, although due diligence remains essential.

4. What emerging trends could influence future API sourcing?
   Increased digitization, regulatory harmonization, environmental standards, and biotech innovations could reshape sourcing strategies, emphasizing transparency and sustainability.

5. What should companies consider beyond cost when selecting API suppliers?
   Companies should evaluate supplier certifications, production capacity, quality consistency, lead times, environmental and ethical standards, and supply chain flexibility.

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References

[1] US Food and Drug Administration (FDA). Guidance for Industry: Good Manufacturing Practice Regulations.
[2] European Medicines Agency (EMA). Good Manufacturing Practice (GMP).
[3] World Health Organization (WHO). WHO GMP Certification Standards.
[4] Pharmaceutical Technology. Trends in API manufacturing and sourcing.
[5] Industry reports on API capacity expansions in China and India (2022–2023).