Bulk Pharmaceutical API Sources for ZYRTEC-D 12 HOUR

Bulk Pharmaceutical API Sources for ZYRTEC-D 12 HOUR

Vendor	Vendor Homepage	Vendor Sku	API Url
Starshine Chemical		2023-05-11B2636

Bulk Active Pharmaceutical Ingredient (API) Sources for ZYRTEC-D 12 HOUR

Last updated: July 30, 2025

Introduction

ZYRTEC-D 12 HOUR, a combination medication containing the antihistamine cetirizine and the decongestant pseudoephedrine, is widely prescribed for managing allergic rhinitis and nasal congestion. Central to manufacturing this drug is sourcing high-quality bulk Active Pharmaceutical Ingredients (APIs)—cetirizine and pseudoephedrine—that meet stringent regulatory standards. The reliability, purity, and compliance of API suppliers directly influence product efficacy, safety, and regulatory approval.

Understanding API Requirements for ZYRTEC-D 12 HOUR

Manufacturers of ZYRTEC-D 12 HOUR demand APIs that meet specifications set by authorities including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regional agencies. These specifications cover purity levels, impurity profiles, residual solvents, moisture content, and microbiological standards. Sourcing APIs from validated suppliers ensures batch-to-batch consistency, regulatory compliance, and risk mitigation.

Key APIs in ZYRTEC-D 12 HOUR

• Cetirizine Hydrochloride: A second-generation antihistamine, selective for peripheral H1 receptors, providing non-sedating allergy relief.
• Pseudoephedrine Hydrochloride: A sympathomimetic agent acting on alpha-adrenergic receptors to induce vasoconstriction and decongest nasal passages.

Both APIs require strict quality control and supply chain integrity.

Global API Suppliers for Cetirizine Hydrochloride

1. Mitsubishi Tanabe Pharma Corporation (Japan)
   Recognized for its robust R&D infrastructure, Mitsubishi supplies cetirizine with high purity certifications aligned with pharmacopoeial standards. Its production facilities comply with cGMP guidelines, ensuring reliable supply.

2. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)
   A prominent API manufacturer with extensive experience in antihistamine APIs, Huahai offers cetirizine hydrochloride conforming to USP and EP standards. The company’s integrated quality systems and capacity for large-scale production make it a preferred partner.

3. Aarti Drugs Limited (India)
   A Maharashtra-based API producer, Aarti supplies cetirizine in bulk quantities, adhering to international standards. Its focus on quality and cost-effective manufacturing serves global markets.

4. PHARMEX LLC (Russia)
   A regional supplier capable of meeting supply demands for cetirizine APIs within the Eurasian markets, compliant with local and international standards.

5. Teva Pharmaceuticals (Israel)
   A global generics leader, Teva produces cetirizine API with rigorous quality controls, ISO-classified manufacturing facilities, and extensive regulatory approvals.

Leading API Suppliers for Pseudoephedrine Hydrochloride

1. Glenmark Pharmaceuticals (India)
   With a comprehensive API manufacturing base, Glenmark provides pseudoephedrine hydrochloride that meets ICH guidelines and pharmacopoeial standards.

2. Sandoz (Novartis division, Switzerland)
   Sandoz offers high-purity pseudoephedrine APIs conforming with strict regulatory standards, with robust supply chain management.

3. Mitsubishi Tanabe Pharma Corporation (Japan)
   Also prominent in pseudoephedrine supply, this entity’s diversified portfolio positions it as a reliable partner.

4. Jiangsu Hengrui Medicine Co., Ltd. (China)
   Known for intensive quality systems, Hengrui supplies pseudoephedrine APIs with competitive pricing and compliance.

5. Ipsen Pharma (France)
   While primarily a specialty pharma company, Ipsen’s API segment provides pseudoephedrine with high purity and documented batch consistency.

Regulatory and Quality Considerations

When sourcing APIs for ZYRTEC-D 12 HOUR, manufacturers must validate suppliers’ compliance with cGMP, adhere to pharmacopoeial standards (USP, EP, BP), and verify batch-specific Certificates of Analysis (CoA). Additionally, suppliers’ adherence to environmental and ethical standards, including responsible sourcing of pseudoephedrine, is critical.

Given pseudoephedrine’s regulation under national precursor control laws, sourcing from licensed suppliers with secure tracking is essential. Ensuring traceability from raw material origin to final API batch release reduces compliance risks.

Emerging Trends in API Sourcing

The increasing demand for biosimilar and generic formulations has expanded APIs’ sourcing networks. Digital platforms and API master files facilitate supplier verification, enhancing transparency. Additionally, some manufacturers pursue economies of scale by consolidating API procurement through global tendering processes, fostering cost efficiencies.

The COVID-19 pandemic underscored the importance of diversified supply chains, prompting many companies to establish multiple supplier relationships across geographies. This diversification mitigates geopolitical risks, supply disruptions, and fluctuating raw material availability.

Conclusion

Reliable sourcing of high-quality cetirizine and pseudoephedrine APIs is fundamental to the consistent manufacturing of ZYRTEC-D 12 HOUR. Leading global suppliers—including Mitsubishi Tanabe Pharma, Zhejiang Huahai, Aarti Drugs, Glenmark, and Sandoz—are recognized for their adherence to international quality standards and regulatory compliance. Strategic procurement considerations, risk management, and ongoing supplier audits are necessary to maintain drug integrity throughout the supply chain.

Key Takeaways

• Quality Over Cost: Prioritize suppliers with proven regulatory compliance, cGMP certification, and transparent quality systems to ensure API purity and safety.
• Regulatory Compliance: Source from licensed suppliers with validated manufacturing processes, especially for pseudoephedrine, given strict precursor regulations.
• Supply Chain Diversification: Establish multiple supplier relationships across different geographies to mitigate geopolitical and logistical risks.
• Continuous Monitoring: Regular audits, batch testing, and review of Certificates of Analysis are essential to maintain supply integrity.
• Future Outlook: Embrace digital sourcing platforms and advance quality agreements to streamline procurement and enhance supply chain resilience.

FAQs

1. What are the key quality standards for sourcing APIs for ZYRTEC-D 12 HOUR?
   Suppliers must meet pharmacopeial standards (USP, EP, BP), comply with cGMP regulations, and provide detailed Certificates of Analysis verifying purity, potency, and impurity profiles.

2. Why is pseudoephedrine sourcing more regulated than cetirizine?
   Pseudoephedrine is a controlled precursor due to its potential use in illicit drug synthesis, requiring licensed suppliers, meticulous tracking, and adherence to national and international regulations.

3. How can manufacturers verify the legitimacy of API suppliers?
   Through regulatory audits, validation of manufacturing facilities, reviewing quality certifications, and verifying compliance histories with agencies like the FDA or EMA.

4. What risks are associated with unreliable API sources?
   Risks include batch failures, product recalls, regulatory sanctions, compromised efficacy, and safety concerns—all of which can damage brand reputation and financial viability.

5. Are there alternative sources for cetirizine and pseudoephedrine APIs?
   Yes, multiple suppliers globally provide these APIs, but manufacturers must assess factors like quality track record, regulatory approval, and supply stability before engagement.

---

References

[1] USFDA, "Guidance for Industry: API Manufacturing," 2022.
[2] European Pharmacopoeia Commission, “Monographs on Cetirizine and Pseudoephedrine,” 2021.
[3] IMS Health Data, "Global API Market Analysis," 2022.
[4] WHO, "Precursor Control Regulations," 2021.
[5] Pharmaceutical Technology, "API Supply Chain Management," 2022.