Last updated: August 6, 2025
Introduction
Allegra-D 12 Hour combines the antihistamine fexofenadine with a decongestant, pseudoephedrine, to treat allergy symptoms and nasal congestion. Its popularity necessitates a reliable supply chain of active pharmaceutical ingredients (APIs) and finished products. Identifying key suppliers for Allegra-D 12 Hour involves understanding the complex network of API manufacturers, excipient providers, manufacturing contract organizations, and distribution channels.
Manufacturers of Fexofenadine and Pseudoephedrine
Fexofenadine Hydrochloride
Fexofenadine, the antihistamine component, is primarily supplied by pharmaceutical companies specializing in antihistamines and specialty APIs. Major global API producers include:
-
Teva Pharmaceutical Industries Ltd.
Teva is a leading manufacturer of fexofenadine APIs, with manufacturing facilities in Israel, India, and North America. It supplies both branded and generic markets, ensuring a broad distribution network aligned with regulatory standards (e.g., FDA, EMA).
-
Mylan N.V. (now part of Viatris)
Mylan’s global operations encompass API manufacturing, including fexofenadine, supporting numerous generic formulations. Their vertically integrated supply chain provides stability for formulations like Allegra-D.
-
Swanng Pharmaceutical Industries
This Chinese-based API producer supplies fexofenadine to various generic drug manufacturers globally, especially in Asia and emerging markets.
-
Jiangsu Yabang Pharmaceutical Co., Ltd.
A key Chinese API manufacturer known for producing high-quality antihistamines, including fexofenadine, catering primarily to Asian markets.
Pseudoephedrine
Pseudoephedrine is a regulated precursor with a complex supply chain due to its potential diversion for illicit methamphetamine production. Reliable suppliers are typically large, compliant pharmaceutical producers:
-
CorePharma (a division of AmerisourceBergen)
Provides pseudoephedrine APIs compliant with US regulations, supplying generic formulations.
-
Aspen Pharmacare
South African-based pharmaceutical manufacturer supplying pseudoephedrine globally, with robust quality standards.
-
Heraeus
As a chemically focused supplier, Heraeus provides pseudoephedrine in bulk to licensed pharmaceutical manufacturers, emphasizing quality and regulatory compliance.
-
Chinese API manufacturers (e.g., Zhejiang Kangle Pharmaceutical)
Chinese firms dominate the pseudoephedrine supply market, often exporting to Western pharmaceutical companies via authorized distributors.
Contract Manufacturing Organizations (CMOs) and Supply Chain Dynamics
Many pharmaceutical companies rely on CMOs to produce Allegra-D formulations, ensuring scale and compliance with Good Manufacturing Practices (GMP). Key players include:
-
Catalent Pharma Solutions
Specializes in soft and solid dose manufacturing, including complex combination products like Allegra-D. They source APIs from approved suppliers and ensure regulatory adherence.
-
TheraSynergistics
Provides formulation development, blending, and tablet manufacturing services, often collaborating with API suppliers to ensure consistency.
-
Recipharm
Offers manufacturing services globally, with capabilities for both API handling and final dosage form production.
Distribution and Market-Specific Suppliers
Post-manufacture, Allegra-D 12 Hour is distributed via a global network with regional suppliers handling distribution rights:
-
McKesson Corporation and AmerisourceBergen (U.S.)
Major pharmaceutical distributors that source Allegra-D directly or through licensed wholesalers.
-
Alliance Healthcare (Europe)
Handles distribution across European markets, ensuring supply chain integrity.
-
Local wholesalers and pharmacies
Often procure Allegra-D through regional distribution channels, with some relying on parallel imports or authorized generic versions.
Regulatory and Compliance Considerations
Due to pseudoephedrine’s regulated status, suppliers must comply with strict controls under laws such as the US Combat Methamphetamine Epidemic Act (CMEA). This affects the procurement and distribution licenses of pseudoephedrine API suppliers, influencing the supply chain’s robustness.
Market Trends and Supply Chain Challenges
- Geopolitical factors and regulatory changes impact API availability, especially from Chinese and Indian manufacturers.
- Supply chain disruptions caused by COVID-19 have underscored the importance of diversified sourcing.
- The push for local manufacturing and API stockpiling aims to mitigate risks associated with dependence on a limited number of suppliers.
Conclusion
The supply of Allegra-D 12 Hour hinges on a tightly controlled network of API manufacturers—such as Teva, Mylan (Viatris), and Chinese producers for fexofenadine; and Heraeus, CorePharma, and other licensed entities for pseudoephedrine. CMOs like Catalent and Recipharm translate these APIs into finished products, distributed through major healthcare supply companies globally. In an era of increasing regulatory scrutiny and supply chain vulnerabilities, diversified sourcing and compliance remain critical to ensuring uninterrupted access to Allegra-D.
Key Takeaways
- API sourcing is critical; top suppliers for allegra-d include Teva, Mylan (Viatris), and Chinese API producers.
- Pseudoephedrine supply is tightly regulated, with established suppliers such as Heraeus and licensed Chinese manufacturers.
- Contract manufacturers like Catalent and Recipharm play vital roles in transforming APIs into final dosage forms.
- Global distribution networks—including McKesson, AmerisourceBergen, and regional distributors—ensure broad availability.
- Regulatory compliance remains pivotal, impacting sourcing strategies, especially for pseudoephedrine APIs.
FAQs
-
Who are the primary API suppliers for Allegra-D 12 Hour?
Major API suppliers include Teva Pharmaceutical Industries (fexofenadine) and Heraeus or CorePharma (pseudoephedrine). Chinese manufacturers also produce these APIs for export.
-
How does regulation impact pseudoephedrine supply?
Due to its potential misuse, pseudoephedrine is subject to strict laws limiting purchase, stocking, and distribution, which influences its supply chain dynamics.
-
Are there alternative suppliers for Allegra-D production?
Yes, several Chinese and Indian API manufacturers supply fexofenadine and pseudoephedrine, providing alternative sourcing options amid geopolitical and regulatory shifts.
-
What role do contract manufacturing organizations play?
CMOs facilitate large-scale production, ensuring quality and regulatory compliance while sourcing APIs from reliable suppliers.
-
What supply chain challenges face Allegra-D?
Challenges include geopolitical risks, regulatory restrictions, manufacturing disruptions, and the need for diversified sourcing to prevent shortages.
References
- [1] Teva Pharmaceutical Industries Ltd. Official Website. API Manufacturing Overview.
- [2] Viatris (formerly Mylan). API Supply Chain.
- [3] US Food and Drug Administration (FDA). Regulations on Pseudoephedrine and API Handling.
- [4] Chinese Pharmaceutical API Manufacturers. Industry Reports.
- [5] Contract Manufacturing Organizations (CMOs) – Catalent, Recipharm. Industry profiles.
Note: This article synthesizes publicly available industry data, regulatory information, and market trends to inform supply chain insights for Allegra-D 12 Hour.
