Suppliers and packagers for ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION

ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786	NDA	Chattem, Inc.	41167-4310-2	1 BLISTER PACK in 1 CARTON (41167-4310-2) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	2011-03-03
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786	NDA	Chattem, Inc.	41167-4310-4	2 BLISTER PACK in 1 CARTON (41167-4310-4) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	2011-03-03
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786	NDA	Chattem, Inc.	41167-4310-6	3 BLISTER PACK in 1 CARTON (41167-4310-6) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	2011-03-03
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786	NDA	A-S Medication Solutions	50090-1203-0	1 BLISTER PACK in 1 CARTON (50090-1203-0) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	2011-03-03

ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION: KEY SUPPLIER LANDSCAPE

Last updated: February 19, 2026

This report details the primary suppliers for the active pharmaceutical ingredients (APIs) and excipients used in the formulation of Allegra-D 12 Hour Allergy and Congestion. Understanding this supply chain is critical for risk assessment and strategic planning in pharmaceutical manufacturing and investment.

WHO ARE THE PRIMARY API SUPPLIERS FOR ALLEGRA-D 12 HOUR?

The key active pharmaceutical ingredients in Allegra-D 12 Hour Allergy and Congestion are Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride. The supply chain for these APIs is complex, involving multiple global manufacturers.

• Fexofenadine Hydrochloride Suppliers:

  • Teva Pharmaceutical Industries Ltd. is a significant global manufacturer of generic and branded pharmaceuticals, including Fexofenadine Hydrochloride. Teva has manufacturing sites in North America, Europe, and Asia, allowing for diversified sourcing.
  • Sun Pharmaceutical Industries Ltd., an Indian multinational pharmaceutical company, is another major producer of Fexofenadine Hydrochloride. Sun Pharma operates extensive manufacturing facilities in India and has a strong presence in regulated markets.
  • Dr. Reddy's Laboratories Ltd., an Indian pharmaceutical company, also manufactures Fexofenadine Hydrochloride. They are known for their robust API production capabilities and global distribution network.
  • Aurobindo Pharma Limited, also based in India, is a significant supplier of various APIs, including Fexofenadine Hydrochloride, serving global markets.

• Pseudoephedrine Hydrochloride Suppliers:

  • The production and distribution of Pseudoephedrine Hydrochloride are subject to strict regulatory controls due to its use in illicit drug manufacturing. Suppliers are typically highly regulated and may operate under specific licenses.
  • Cardinal Health, Inc., a U.S.-based healthcare company, acts as a major distributor and sometimes manufacturer of pharmaceutical ingredients, including those with regulatory oversight like Pseudoephedrine Hydrochloride. Their role often involves managing the complex logistics and compliance for such substances.
  • McKesson Corporation, another major U.S. healthcare company, also plays a crucial role in the distribution of APIs. Their extensive supply chain network is critical for ensuring the availability of regulated ingredients.
  • Specific API manufacturers specializing in controlled substances, often operating under strict government mandates, also contribute to the Pseudoephedrine Hydrochloride supply. These manufacturers are not always publicly disclosed due to the sensitive nature of the product.

WHAT ARE THE KEY EXCIPIENTS AND THEIR SUPPLIERS?

Excipients are inactive substances used as a vehicle or medium for a drug. For Allegra-D 12 Hour Allergy and Congestion, common excipients include binders, fillers, disintegrants, lubricants, and coating agents.

• Binders: These hold the ingredients together.

  • Microcrystalline Cellulose (MCC): Widely used as a binder and filler. Suppliers include:
    • DuPont de Nemours, Inc. (now part of IFF) through its nutrition and biosciences division.
    • JRS Pharma (part of J. Rettenmaier & Söhne Group), a global producer of functional excipients derived from plant fibers.
  • Povidone (Polyvinylpyrrolidone): Used as a binder.
    • BASF SE is a major producer of Povidone under its Kollidon® brand.

• Fillers/Diluents: These add bulk to the formulation.

  • Lactose Monohydrate: A common filler.
    • Arla Foods Ingredients Group P/S is a significant producer of lactose.
    • Davisco Foods International, Inc. (now part of Agropur) also supplies lactose.
  • Starch (e.g., Corn Starch, Potato Starch): Used as a filler and disintegrant.
    • Cargill, Incorporated is a global supplier of starch and starch derivatives.
    • Ingredion Incorporated is another leading global provider of starch-based ingredients.

• Disintegrants: These help the tablet break apart after administration.

  • Croscarmellose Sodium: A common disintegrant.
    • Ashland Inc. supplies Croscarmellose Sodium under its Ac-Di-Sol® brand.
    • JRS Pharma also offers this excipient.

• Lubricants: These prevent ingredients from sticking to machinery during tablet pressing.

  • Magnesium Stearate: A widely used lubricant.
    • Suppliers are numerous and often specialized chemical manufacturers. Companies like Peter Cremer GmbH & Co. KG and Acme-Hardesty LLC are known providers.

• Coating Agents: These provide a protective layer and aid swallowing.

  • Hypromellose (Hydroxypropyl Methylcellulose - HPMC): A common film-coating agent.
    • The Dow Chemical Company (now part of Dow Inc.) is a major producer of HPMC under brands like Methocel™.
    • Ashland Inc. also supplies HPMC.
  • Titanium Dioxide: Used as a white pigment in coatings.
    • Suppliers include Tronox Holdings plc and Venator Materials PLC.

• Colorants: Used for product identification and aesthetics.

  • Iron Oxides: Often used for coloring.
    • Suppliers are specialized pigment manufacturers, including Lanxess AG.

WHAT ARE THE REGULATORY CONSIDERATIONS FOR KEY SUPPLIERS?

The pharmaceutical supply chain operates under stringent regulatory frameworks designed to ensure product safety, efficacy, and quality. For Allegra-D 12 Hour, specific considerations apply to both API and excipient suppliers.

• API Supplier Regulations:

  • U.S. Food and Drug Administration (FDA): API manufacturers supplying the U.S. market must comply with Current Good Manufacturing Practices (cGMP) as outlined in 21 CFR Part 210 and 211. Facilities are subject to FDA inspections. Drug Master Files (DMFs) are often submitted to the FDA for APIs, providing confidential detailed information about manufacturing, processing, packaging, and storing the API.
  • European Medicines Agency (EMA): Similar cGMP requirements are enforced in the European Union. Certificates of Suitability to the monographs of the European Pharmacopoeia (CEP) are often required.
  • Controlled Substances: Pseudoephedrine Hydrochloride is a List I chemical under the Controlled Substances Act in the U.S. Suppliers must adhere to stringent DEA regulations regarding registration, record-keeping, reporting, and security. International controls also apply through bodies like the International Narcotics Control Board (INCB).
  • Global Harmonization: Efforts like the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provide guidelines (e.g., ICH Q7 for API GMP) that many regulatory bodies adopt, promoting global consistency.

• Excipient Supplier Regulations:

  • While excipients are not APIs, their quality directly impacts the final drug product. Excipient manufacturers are increasingly expected to adhere to cGMP principles, particularly for critical excipients.
  • USP-NF (United States Pharmacopeia–National Formulary) and Ph. Eur. (European Pharmacopoeia): Excipients must meet the compendial standards defined in these pharmacopeias.
  • ICH Q3D (Guideline for Elemental Impurities): Manufacturers must control elemental impurities in excipients.
  • Supplier Qualification: Pharmaceutical companies rigorously qualify their excipient suppliers, often through audits, questionnaires, and review of quality agreements, to ensure consistent quality and compliance.

HOW DO SUPPLY CHAIN RISKS IMPACT ALLEGRA-D 12 HOUR PRODUCTION?

Disruptions in the supply chain for Allegra-D 12 Hour can lead to significant production delays, increased costs, and potential drug shortages. Key risks include:

• Geopolitical Instability: Many API and excipient manufacturing hubs are concentrated in specific regions. Geopolitical events can disrupt production or trade routes.
• Regulatory Changes: New regulations or stricter enforcement can impact manufacturing processes, require facility upgrades, or affect the availability of certain chemicals (e.g., environmental regulations impacting chemical synthesis).
• Quality Issues: A quality failure at an API or critical excipient supplier can halt production for the entire finished drug product until the issue is resolved and a new supplier is qualified, which is a lengthy process.
• Raw Material Shortages: Dependence on specific raw materials for API or excipient synthesis can lead to shortages if the upstream supply is disrupted.
• Intellectual Property and Patent Expirations: While Allegra-D 12 Hour is a well-established product, ongoing patent considerations for specific manufacturing processes or novel formulations can influence supplier dynamics.
• Transportation and Logistics: Global shipping disruptions, port congestion, or increased freight costs can impact the timely delivery of raw materials and finished goods.
• Cybersecurity: As supply chains become more digitized, cybersecurity risks at supplier facilities can lead to operational disruptions.

WHAT IS THE GEOGRAPHIC DISTRIBUTION OF KEY SUPPLIERS?

The global nature of pharmaceutical manufacturing means key suppliers for Allegra-D 12 Hour are located across multiple continents. This diversification is a strategy to mitigate risks but also creates complex logistical networks.

• Asia:

  • India: A major hub for API manufacturing, particularly for Fexofenadine Hydrochloride and various excipients. Companies like Sun Pharma, Dr. Reddy's, and Aurobindo Pharma are based here.
  • China: A significant producer of a broad range of APIs and excipients, including intermediates and bulk chemicals. Many chemical suppliers for lubricants and coatings are also located here.

• North America:

  • United States: Home to major distributors and some API manufacturers (especially for regulated substances), as well as key excipient producers and formulators. Cardinal Health and McKesson are critical distributors. Dow (now Dow Inc.) is a key excipient supplier.
  • Canada: Has a notable pharmaceutical manufacturing sector, though it is more focused on finished dosage forms than primary API production for global supply.

• Europe:

  • Germany: Home to large chemical and pharmaceutical companies like BASF SE, a key excipient supplier.
  • United Kingdom: Has a strong pharmaceutical research and manufacturing base.
  • Switzerland: Hosts major chemical and pharmaceutical corporations.
  • Netherlands: Significant presence in the chemical and life sciences sectors, with excipient suppliers.

CONCLUSION

The supply chain for Allegra-D 12 Hour Allergy and Congestion is robust, drawing on a diverse set of global manufacturers for its active ingredients and excipients. Key API suppliers, including Teva, Sun Pharma, and Dr. Reddy's, are supported by a broad network of excipient providers like DuPont (IFF), JRS Pharma, BASF, Ashland, and Ingredion. Strict adherence to cGMP, pharmacopeial standards, and controlled substance regulations is paramount for all involved parties. Understanding the geographic distribution and regulatory landscape of these suppliers is essential for assessing supply chain resilience and identifying potential vulnerabilities.

KEY TAKEAWAYS

• Fexofenadine Hydrochloride is primarily sourced from Indian API manufacturers such as Sun Pharma and Dr. Reddy's.
• Pseudoephedrine Hydrochloride supply is managed under strict regulatory oversight, with major distributors like Cardinal Health and McKesson playing key roles.
• Essential excipients like Microcrystalline Cellulose, Povidone, and Hypromellose are supplied by global chemical giants including DuPont (IFF), BASF, and Dow Inc.
• All suppliers must comply with rigorous cGMP standards and pharmacopeial requirements to ensure product quality and patient safety.
• Geopolitical factors, regulatory changes, and quality control failures represent significant risks to the consistent production of Allegra-D 12 Hour.

FREQUENTLY ASKED QUESTIONS

• Which regulatory bodies oversee the API suppliers for Allegra-D 12 Hour in the United States? The U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) are the primary regulatory bodies. The FDA enforces cGMP and reviews Drug Master Files (DMFs), while the DEA regulates Pseudoephedrine Hydrochloride as a controlled substance.

• Are there any single-source critical raw materials for Allegra-D 12 Hour that pose a significant supply risk? While specific critical intermediates can be subject to limited suppliers, the overall API and excipient landscape for Allegra-D 12 Hour is diversified across multiple manufacturers and geographies, mitigating extreme single-source dependency for the overall formulation. However, specialized chemical precursors for certain APIs or excipients can be concentrated.

• What is the typical lead time required to qualify a new API supplier for Allegra-D 12 Hour? Qualifying a new API supplier typically requires a comprehensive process including a thorough quality audit of the manufacturing facility, review of DMFs or equivalent documentation, and potentially analytical method validation and pilot batch testing. This process can take anywhere from 6 to 18 months, depending on the complexity and the rigor of the pharmaceutical company's quality system.

• How does the classification of Pseudoephedrine Hydrochloride as a controlled substance impact its supply chain? The controlled substance status of Pseudoephedrine Hydrochloride mandates stringent record-keeping, reporting, and security measures for all handlers, from manufacturers to distributors. This includes quotas on production and import/export controls, as well as heightened regulatory scrutiny by bodies like the DEA, which can affect availability and cost.

• What is the role of excipient supplier audits in ensuring the quality of Allegra-D 12 Hour? Excipient supplier audits are critical for verifying that suppliers adhere to cGMP principles, control elemental impurities, meet compendial standards (USP-NF, Ph. Eur.), and have robust quality management systems in place. These audits help pharmaceutical companies assure the consistent quality of the inactive ingredients, which directly impacts the performance and safety of the final Allegra-D 12 Hour product.

[1] U.S. Food and Drug Administration. (n.d.). 21 CFR Part 210: Current Good Manufacturing Practice In Manufacturing, Processing, Packing, or Holding of Drugs; General. U.S. Government Publishing Office. [2] U.S. Food and Drug Administration. (n.d.). 21 CFR Part 211: Current Good Manufacturing Practice For Finished Pharmaceuticals. U.S. Government Publishing Office. [3] U.S. Drug Enforcement Administration. (n.d.). Controlled Substances Act. U.S. Drug Enforcement Administration. [4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2009). ICH Harmonised Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7. ICH. [5] United States Pharmacopeia. (n.d.). United States Pharmacopeia–National Formulary (USP-NF). USP. [6] European Directorate for the Quality of Medicines & HealthCare. (n.d.). European Pharmacopoeia. EDQM. [7] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2015). ICH Harmonised Guideline: Guideline for Elemental Impurities Q3D. ICH.