CLARITIN-D 24 HOUR: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bayer Healthcare Llc	CLARITIN-D 24 HOUR	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	020470	NDA	Bayer HealthCare LLC.	11523-4332-1	1 BLISTER PACK in 1 CARTON (11523-4332-1) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2009-12-01
Bayer Healthcare Llc	CLARITIN-D 24 HOUR	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	020470	NDA	Bayer HealthCare LLC.	11523-4332-2	1 BLISTER PACK in 1 CARTON (11523-4332-2) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2009-12-01
Bayer Healthcare Llc	CLARITIN-D 24 HOUR	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	020470	NDA	Bayer HealthCare LLC.	11523-4332-3	3 BLISTER PACK in 1 CARTON (11523-4332-3) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2009-12-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

CLARITIN-D 24 HOUR, a combination prescription drug for nasal allergy symptoms and sinus congestion, relies on a specific set of suppliers for its active pharmaceutical ingredients (APIs) and critical excipients. The primary API, loratadine, is a second-generation antihistamine. The second API, pseudoephedrine sulfate, is a nasal decongestant. Key excipients include cellulose, povidone, and magnesium stearate. Understanding the supplier landscape for these components is critical for supply chain resilience, cost management, and regulatory compliance in the pharmaceutical industry.

Who Supplies Loratadine for CLARITIN-D 24 HOUR?

Loratadine, the antihistamine component of CLARITIN-D 24 HOUR, is a widely manufactured API. Multiple global suppliers produce loratadine, with varying levels of regulatory compliance and production capacity. The selection of a loratadine supplier by the drug manufacturer involves rigorous qualification processes assessing Good Manufacturing Practices (GMP) adherence, impurity profiles, and supply chain security.

Key manufacturers and distributors of loratadine include:

Bayer AG: As the original innovator and current marketer of CLARITIN-D 24 HOUR (through its consumer health division), Bayer likely maintains internal production or has established long-term, qualified supplier relationships for its loratadine API. Specific supplier details are often proprietary.
Indian API Manufacturers: A significant portion of global loratadine production originates from India. Companies like Sun Pharmaceutical Industries Ltd., Dr. Reddy's Laboratories, and Aurobindo Pharma are major producers of generic APIs, including loratadine. These companies frequently supply to finished dosage form manufacturers worldwide.
Chinese API Manufacturers: China is another substantial source of pharmaceutical APIs. Manufacturers such as Zhejiang Huahai Pharmaceutical Co., Ltd. and Zhejiang NHU Co., Ltd. are known for their large-scale API production, including loratadine.

The qualification of a loratadine supplier by a pharmaceutical company involves a multi-stage process:

Initial Qualification: Assessment of the supplier's regulatory history, GMP certification (e.g., FDA, EMA), and financial stability.
Technical Evaluation: Review of the supplier's manufacturing process, impurity control strategy, and analytical methods.
On-site Audit: A thorough inspection of the manufacturing facility to ensure compliance with GMP standards and assess operational capabilities.
Drug Master File (DMF) Review: Examination of the supplier's submitted DMF to the regulatory authorities, detailing the API’s manufacturing process and controls.
Sample Testing: Independent testing of API batches from the prospective supplier to verify quality and consistency.

Who Supplies Pseudoephedrine Sulfate for CLARITIN-D 24 HOUR?

Pseudoephedrine sulfate is a controlled substance in many jurisdictions due to its use in the illicit manufacture of methamphetamine. Consequently, its sourcing and supply chain are subject to stringent regulations and oversight. Manufacturers of CLARITIN-D 24 HOUR must work with suppliers who are licensed to handle and distribute controlled substances and adhere to strict quotas and security protocols.

Major suppliers and potential sources for pseudoephedrine sulfate include:

Controlled Substance Manufacturers: Companies specializing in the production of controlled APIs are the primary sources. These are typically large, established pharmaceutical chemical manufacturers with robust compliance departments.
Specific Producers: While proprietary information often shields exact supplier relationships, companies like Cardinal Health, Inc. (through its Alachua, Florida facility, a significant producer of pseudoephedrine) and Mallinckrodt Pharmaceuticals (historically a major producer of pseudoephedrine and its salts) have been prominent in the pseudoephedrine market. However, regulatory pressures and market shifts can impact these roles.
International Producers with US/EU Distribution: Some international manufacturers may produce pseudoephedrine sulfate and distribute it through licensed importers and distributors within target markets.

The regulatory environment significantly impacts the supply of pseudoephedrine sulfate. In the United States, the Drug Enforcement Administration (DEA) regulates the manufacturing, distribution, and dispensing of List I chemicals, including pseudoephedrine. This involves:

Quotas: Annual manufacturing quotas are set by the DEA to limit the total amount of pseudoephedrine that can be produced.
Licensing and Registration: All entities involved in handling pseudoephedrine must be registered with the DEA.
Record Keeping and Reporting: Strict requirements for tracking and reporting all transactions.
Security Measures: Suppliers must implement robust security protocols to prevent diversion.

These regulations can lead to supply chain complexities and higher costs compared to non-controlled APIs. Pharmaceutical companies must maintain strong relationships with DEA-registered suppliers and ensure their own internal processes for handling controlled substances meet all federal and state requirements.

Who Supplies Key Excipients for CLARITIN-D 24 HOUR?

CLARITIN-D 24 HOUR utilizes several common pharmaceutical excipients that are essential for tablet formulation, stability, and release characteristics. These excipients are generally widely available from multiple suppliers, but the specific grades and quality required for pharmaceutical use are paramount.

Microcrystalline Cellulose

Microcrystalline cellulose (MCC) is a widely used binder and diluent in solid oral dosage forms. It provides compressibility and aids in tablet disintegration.

Key Suppliers:
- DuPont (formerly FMC Corporation): A leading global supplier of MCC, with brands like EMD Millipore offering various grades.
- Asahi Kasei Corporation: Another significant producer of MCC.
- Roquette Frères: Offers a range of cellulose-based excipients.

The selection criteria for MCC include:

Particle Size Distribution: Affects flowability and compressibility.
Moisture Content: Impacts stability and processing.
Bulk Density: Influences tablet size.
Impurities: Must meet pharmacopeial standards (e.g., USP, EP).

Povidone

Povidone (polyvinylpyrrolidone, PVP) is a versatile polymer used as a binder, disintegrant, and solubilizer. It helps to hold the tablet ingredients together and can influence drug release.

Key Suppliers:
- BASF SE: A major global producer of povidone under brands like Kollidon.
- Ashland Global Holdings Inc.: Offers povidone and related polymers for pharmaceutical applications.
- National Company for Petrochemicals (NCP): A producer of PVP in certain regions.

Povidone grades are differentiated by their K-value, which indicates molecular weight and viscosity, influencing binding strength and solubility.

Magnesium Stearate

Magnesium stearate is a common lubricant used in tablet manufacturing. It prevents the tablet formulation from sticking to the punches and dies of tablet presses, ensuring smooth ejection and preventing damage.

Key Suppliers:
- J.T. Baker Chemical Company (Avantor Performance Materials): A well-known supplier of high-purity magnesium stearate.
- Norwegian Talc AS: A producer of various mineral-based excipients, including magnesium stearate.
- Sigma-Aldrich (Merck KGaA): Offers a broad range of laboratory chemicals and pharmaceutical excipients.

The critical attributes for magnesium stearate include:

Purity: Free from heavy metals and other contaminants.
Fatty Acid Composition: Primarily stearic and palmitic acids.
Particle Size and Morphology: Affects its distribution within the blend and lubricating efficiency.
Lubricity: Its effectiveness in reducing friction.

The use of magnesium stearate as a lubricant is carefully controlled, as excessive amounts can negatively impact tablet disintegration and dissolution rates.

Supply Chain Considerations and Regulatory Landscape

The supply chain for CLARITIN-D 24 HOUR is complex, involving global sourcing of APIs and excipients. Pharmaceutical manufacturers must navigate several critical considerations:

Quality and Compliance: All suppliers must adhere to stringent Good Manufacturing Practices (GMP) as required by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This includes rigorous quality control, documentation, and validation of manufacturing processes.
Regulatory Filings: Manufacturers must maintain detailed Drug Master Files (DMFs) or equivalent documentation for all APIs and critical excipients. These filings detail the manufacturing process, controls, and impurity profiles. Any changes in supplier or manufacturing process require regulatory notification and potentially re-approval.
Controlled Substance Regulation: The sourcing of pseudoephedrine sulfate is governed by strict international and national regulations (e.g., DEA in the U.S.). Manufacturers must comply with quotas, licensing, security, and reporting requirements. Diversion of pseudoephedrine is a significant concern, leading to intense scrutiny of the supply chain.
Supply Chain Security and Resilience: Pharmaceutical companies invest in robust supply chain management to mitigate risks such as natural disasters, geopolitical instability, and supplier-specific issues. This often involves qualifying multiple suppliers for critical components, maintaining adequate inventory levels, and conducting risk assessments.
Cost Management: While quality and compliance are paramount, pharmaceutical companies also seek cost-effective sourcing. This involves competitive bidding, long-term supplier agreements, and optimization of manufacturing processes. However, the cost of controlled substances like pseudoephedrine sulfate is often higher due to regulatory burdens.
Intellectual Property: While loratadine is off-patent and widely available as a generic, the specific formulation and manufacturing processes for CLARITIN-D 24 HOUR are proprietary. This influences the selection of suppliers who can meet formulation-specific requirements and maintain confidentiality.

The pharmaceutical industry's reliance on a global network of suppliers necessitates a proactive approach to supply chain management. For a product like CLARITIN-D 24 HOUR, which combines a widely available API with a tightly regulated one, understanding the specific dynamics of each component's supplier landscape is essential for maintaining market presence and ensuring patient access.

Key Takeaways

Loratadine, a primary API for CLARITIN-D 24 HOUR, is sourced globally, with significant production in India and China, alongside potential internal Bayer production.
Pseudoephedrine sulfate, a controlled substance, faces highly regulated sourcing from licensed manufacturers and distributors, with entities like Cardinal Health and Mallinckrodt historically significant.
Excipients such as microcrystalline cellulose, povidone, and magnesium stearate are supplied by major global chemical and pharmaceutical ingredient manufacturers like DuPont, BASF, and Avantor.
Regulatory compliance (GMP, controlled substance regulations), quality assurance, and supply chain security are paramount for all suppliers.
The stringent controls on pseudoephedrine sulfate contribute significantly to its supply chain complexity and cost.

FAQs

What is the primary driver for selecting a loratadine supplier for CLARITIN-D 24 HOUR? The primary drivers are consistent quality meeting pharmacopeial standards, robust GMP compliance demonstrated through audits and regulatory filings (e.g., DMF), and reliable supply capacity.
How do DEA quotas for pseudoephedrine sulfate impact the CLARITIN-D 24 HOUR supply chain? DEA quotas limit the total amount of pseudoephedrine sulfate that can be manufactured annually, directly influencing its availability and potentially increasing lead times and costs for manufacturers of products like CLARITIN-D 24 HOUR.
Are there specific grades of microcrystalline cellulose required for CLARITIN-D 24 HOUR? Yes, specific grades of microcrystalline cellulose are selected based on particle size distribution, moisture content, and bulk density to ensure optimal tablet compressibility, flowability, and disintegration.
What are the potential risks associated with sourcing magnesium stearate? Potential risks include contamination with heavy metals or other impurities, inconsistent lubrication efficiency due to variations in particle size or fatty acid composition, and supplier reliability impacting production schedules.
Can a manufacturer of CLARITIN-D 24 HOUR switch suppliers for its APIs or excipients without regulatory notification? No, any change in a qualified supplier for an API or a critical excipient requires notification to regulatory authorities (e.g., FDA) and may necessitate submission of updated Drug Master Files (DMFs) or other supporting documentation, potentially leading to re-approval processes.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from [FDA Website - Specific page on DMFs would be cited here if available and relevant to general DMF understanding] [2] U.S. Drug Enforcement Administration. (n.d.). Controlled Substances Act. Retrieved from [DEA Website - Specific page on List I chemicals or CSA would be cited here] [3] Bayer AG. (Annual Reports/Investor Relations). [Information on manufacturing and supply chain is typically found in annual reports or dedicated sections on their corporate website] [4] DuPont. (Product Literature/Technical Data Sheets). [Information on microcrystalline cellulose offerings and specifications is available through their commercial and technical documentation] [5] BASF SE. (Product Literature/Technical Data Sheets). [Information on povidone grades and applications is detailed in their product catalogs and technical guides] [6] Avantor Performance Materials (J.T. Baker). (Product Catalogs/Technical Data Sheets). [Details on magnesium stearate and other excipients can be found in their product listings]

Suppliers and packagers for CLARITIN-D 24 HOUR