Last updated: July 29, 2025
ppliers for the Pharmaceutical Drug: ZYRTEC-D 12 HOUR
Introduction
ZYRTEC-D 12 HOUR is a combination medication primarily prescribed for allergy relief, featuring cetirizine hydrochloride (an antihistamine) and pseudoephedrine sulfate (a nasal decongestant). Marketed by Johnson & Johnson, ZYRTEC-D 12 HOUR is widely distributed across diverse markets, primarily in North America. Its manufacturing supply chain comprises authorized pharmaceutical manufacturers, licensed contract manufacturers, and authorized distributors. Ensuring an understanding of key suppliers enhances the capacity for strategic sourcing, risk management, and regulatory compliance.
Manufacturers of Active Pharmaceutical Ingredients (APIs)
Cetirizine Hydrochloride API Suppliers
The active antihistamine component, cetirizine hydrochloride, has a well-established global supply chain. Major API suppliers include:
- Mitsubishi Chemical (Japan): Mitsubishi supplies cetirizine APIs to various pharmaceutical companies, leveraging advanced synthesis technology and stringent quality control.
- Synthesis & Chemical Companies in India: Several Indian generic API manufacturers, such as Hetero Drugs, Mylan (now part of Viatris), and Dr. Reddy’s Laboratories, produce cetirizine hydrochloride at scale, catering to both domestic and international markets.
- U.S. and European Suppliers: Companies such as Teva Pharmaceuticals and Synthesis & Chemical Ltd., supply high-quality cetirizine APIs primarily for markets in North America and Europe.
Pseudoephedrine Sulfate API Suppliers
Pseudoephedrine remains a controlled precursor in some jurisdictions due to its potential for misuse. Authorized suppliers include:
- Chinese Manufacturers (e.g., Shandong Xinhua Pharmaceutical): A significant source of pseudoephedrine, often exported globally, subject to strict regulations.
- Indian API Producers: Companies like Aarti Drugs and Gujarat State Fertilizers & Chemicals Ltd. produce pseudoephedrine under license, complying with local and international regulations.
- European and U.S. API Suppliers: Sandoz and Sanofi supply pseudoephedrine APIs for regulated markets, adhering to Good Manufacturing Practices (GMP).
Contract Manufacturing Organizations (CMOs)
Given the complexity of formulation and regulatory compliance, many pharmaceutical companies engage contract manufacturing organizations (CMOs) for ZYRTEREC-D 12 HOUR production. Key players include:
- Famar (Greece): Known for aseptic filling and formulation of combination drugs, adhering to strict GMP guidelines.
- Recipharm (Sweden): A leading CMO with extensive experience in solid oral dose manufacturing, including controlled-release formulations like ZYRTEC-D 12 HOUR.
- Patheon (Thermo Fisher Scientific): Provides end-to-end manufacturing solutions, from API sourcing to finished product packaging.
Distribution and Logistics
Distribution channels for ZYRTEC-D 12 HOUR involve authorized wholesalers, pharmacy chains, and direct-to-pharmacy delivery systems. Large pharmaceutical distributors such as McKesson, Cardinal Health, and AmerisourceBergen serve as primary channels for supply chain distribution throughout North America. These companies maintain extensive networks of licensed suppliers, ensuring product integrity and regulatory compliance.
Regulatory and Legal Considerations
The pseudoephedrine component's legal status enforces strict supply control, with suppliers needing licensing and compliance with the Combat Methamphetamine Epidemic Act (CMEA) in the United States. Internationally, suppliers operate under the International Narcotics Control Board (INCB) regulations, imposing traceability and documentation standards.
Key manufacturers of the finished ZYRTEC-D 12 HOUR product are Johnson & Johnson's Janssen division, which sources APIs from authorized suppliers and partners with GMP-compliant contract manufacturers to ensure consistent quality and supply security.
Future Supply Chain Dynamics
The ongoing global sourcing shifts, regulatory changes, and supply chain disruptions—exacerbated by COVID-19—highlight the importance of diversified supplier bases. Emerging markets continue to expand their role, with increased oversight to prevent counterfeit products and ensure traceability.
Conclusion
The supply landscape for ZYRTEC-D 12 HOUR hinges on a globally interconnected network of API manufacturers, contract manufacturing partners, and authorized distributors. While Johnson & Johnson maintains oversight of sourcing and manufacturing integrity, supply chain resilience depends on diversified sourcing, compliance adherence, and robust logistics management.
Key Takeaways
- The APIs for ZYRTEC-D 12 HOUR predominantly originate from Japan, India, China, and Europe, each subject to stringent quality standards.
- Contract manufacturing organizations play pivotal roles in ensuring scalable, compliant production.
- Regulatory compliance, especially regarding pseudoephedrine, is central to supply chain management.
- Market volatility and geopolitical factors necessitate diversified supplier portfolios.
- Understanding these supply chains offers strategic advantage for procurement, risk mitigation, and ensuring continuous drug availability.
FAQs
1. Who are the primary API suppliers for ZYRTEC-D 12 HOUR?
API suppliers include Mitsubishi Chemical (Japan) for cetirizine hydrochloride and Chinese, Indian, and European manufacturers for pseudoephedrine sulfate, all operating under strict quality and regulatory standards.
2. Are there any global concerns affecting ZYRTEC-D 12 HOUR supply?
Yes. Supply chain disruptions from geopolitical issues, regulatory changes concerning pseudoephedrine, and COVID-19-induced manufacturing delays have temporarily impacted availability in certain regions.
3. How does Johnson & Johnson ensure the quality of APIs used in ZYRTEC-D 12 HOUR?
Johnson & Johnson sources APIs only from GMP-certified manufacturers, with rigorous quality assessments and audits aligned with international standards.
4. What role do contract manufacturing organizations play in ZYRTEC-D 12 HOUR supply?
CMOs are responsible for formulation, finished product manufacturing, and packaging, ensuring scalability, compliance, and consistent product quality.
5. How can companies mitigate risks in the ZYRTEC-D 12 HOUR supply chain?
Diversifying suppliers, establishing strong regulatory compliance protocols, maintaining safety stock, and building transparent logistics networks are essential strategies.
Sources
- Johnson & Johnson Corporate Website. (2023). "Product Information and Supply Chain."
- International Narcotics Control Board. (2022). "Guidelines on pseudoephedrine handling and control."
- Pharmaceutical Technology. (2023). "Global API Trends and Supply Chain Dynamics."
- U.S. Food & Drug Administration. (2022). "GMP Compliance and API Certification."
- industry reports on contract manufacturing and global pharmaceutical supply chain management.
