Suppliers and packagers for CLARINEX-D 12 HOUR

CLARINEX-D 12 HOUR

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313	NDA	Organon LLC	78206-120-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (78206-120-01)	2021-06-01

Suppliers for the Pharmaceutical Drug: CLARINEX-D 12 HOUR

Last updated: August 4, 2025

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Overview of CLARINEX-D 12 HOUR

CLARINEX-D 12 HOUR is an antihistamine combination primarily used to treat allergic rhinitis and related nasal symptoms. The medication contains loratadine, a second-generation antihistamine, combined with pseudoephedrine, a nasal decongestant. Its formulation offers extended relief from allergy symptoms with a single dose lasting up to 12 hours, making it a popular over-the-counter (OTC) medication in various markets globally.

Given its widespread utilization, the supply chain for CLARINEX-D 12 HOUR involves multiple stakeholders, including active pharmaceutical ingredient (API) manufacturers, finished drug producers, distributors, and authorized resellers. Understanding the landscape of supplier entities, especially amid regulatory variances and evolving market dynamics, is vital for pharmaceutical companies, healthcare providers, and investors.

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Global Supply Landscape: Key Manufacturers and Suppliers

1. Original Equipment Manufacturers (OEMs) and Brand Owners

The original formulation of CLARINEX-D 12 HOUR was developed by Merck & Co., now known as MSD outside the United States and Canada. MSD is the proprietary rights holder for the brand, and its supply chain extends through its authorized manufacturing facilities.

2. API Manufacturers for Loratadine and Pseudoephedrine

Loratadine and pseudoephedrine, the active ingredients, are produced by multiple API manufacturers across different regions—primarily China, India, and Western countries.

• Loratadine:

  • Hetero Labs (India): A major producer supplying both branded and generic loratadine APIs.
  • Moscow-based Biocad: Reports indicate some involvement in loratadine API manufacturing.
  • Chinese API producers: Numerous Chinese firms such as Zhejiang Medicine Co., Ltd., and Aurobindo Pharma produce loratadine APIs meeting international standards.

• Pseudoephedrine:

  • Indian manufacturers: Aurobindo Pharma, Cipla, and Sun Pharma are significantcontributors.
  • Chinese suppliers: Widespread manufacturing capacity with export compliance to global standards.
  • Western supplies: Limited, often sourced through regional wholesale distributors.

3. Finished Dosage Form Manufacturers

• Authorized manufacturing partners:

  • MSD’s Contract Manufacturing: Several contract manufacturing organizations (CMOs) operate under licensing agreements to produce CLARINEX-D 12 HOUR, adhering to Good Manufacturing Practices (GMP).
  • Generic manufacturers: Companies like Teva Pharmaceuticals, Sandoz, and Mylan produce generic versions, leveraging APIs from identified producers.

• Regional Market Variations:

  • In the U.S., products are often sourced from local manufacturers licensed by MSD or authorized generic firms.
  • In emerging markets, local pharmaceutical companies or regional CMOs dominate supply, often sourcing APIs from Chinese or Indian manufacturers.

4. Distributors and Resellers

Distribution of CLARINEX-D 12 HOUR spans pharmacy chains, hospital procurement channels, and OTC retailers. Major pharmaceutical distributors such as McKesson, Cardinal Health, and Alliance Healthcare serve as primary channels in North America and Europe.

In Asia and Africa, regional distributors often source from Chinese and Indian API manufacturers or from authorized regional affiliates of multinational firms.

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Regulatory and Quality Considerations

The legitimacy and quality compliance of suppliers influence supply security. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and others, require strict GMP adherence. Many Chinese and Indian API manufacturers have made significant quality improvements recent years, but regulatory scrutiny and quality audits remain the key determinants for inclusion in supply chains.

MSD’s strategic partnerships with ISO-certified manufacturing firms ensure product integrity. However, counterfeit and substandard products still challenge markets, emphasizing the importance of sourcing from approved suppliers.

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Market Dynamics and Supply Chain Risks

• Global API shortages: Recent disruptions due to the COVID-19 pandemic have impacted API supply, leading to shortages or delays. China’s and India’s lockdowns limited API exports temporarily, prompting manufacturers to diversify suppliers.

• Regulatory restrictions: Increasing regulatory oversight and trade policies restrict sourcing from certain regions, requiring companies to verify supplier certifications diligently.

• Intellectual property (IP) and licensing: MSD maintains proprietary rights and exclusive licensing agreements, limiting access to certain manufacturing entities unless authorized.

• Price Competition: Growing competition among generic producers, especially in India and China, has driven down API costs but also increased the prevalence of low-cost, non-compliant APIs.

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Emerging Trends: Sustainable and Diversified Supply Chains

Many pharmaceutical companies are now investing in diversifying their supply sources to mitigate risks associated with overreliance on specific regions.

• China and India focus: These remain dominant API sources owing to cost and manufacturing capacity.

• Western API development: Some firms are exploring or establishing global API manufacturing centers in Europe and North America, driven by regulatory and quality assurance concerns.

• Sustainable practices: Certain suppliers are adopting environmentally sustainable manufacturing processes aligned with increasingly stringent international standards.

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Conclusion

For stakeholders involved in the supply and procurement of CLARINEX-D 12 HOUR, understanding the multifaceted supply landscape is crucial:

• The API sourcing is predominantly from Indian and Chinese manufacturers, with notable players like Hetero Labs, Aurobindo Pharma, Zhejiang Medicine, and local Chinese API producers.
• Finished dosage production leverages both MSD’s licensed manufacturers and licensed generic producers globally.
• Distribution channels vary across regions, heavily influenced by regulatory frameworks and market dynamics.

Ensuring supply chain security necessitates diligent supplier verification, adherence to regulatory standards, and diversification strategies to mitigate risks associated with geopolitical, regulatory, and logistical disruptions.

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Key Takeaways

• The supply of CLARINEX-D 12 HOUR hinges on multiple regional API manufacturers, mainly in India and China.
• Licensing agreements with original developers, such as MSD, influence authorized manufacturing and distribution.
• Supply chain disruptions, particularly during global emergencies like COVID-19, emphasize the importance of diversification.
• Regulatory compliance and quality assurance are non-negotiable factors for supplier selection.
• Companies should monitor geopolitical and regulatory developments to anticipate supply chain impacts.

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FAQs

1. Who are the primary API suppliers for CLARINEX-D 12 HOUR?
The main API suppliers include Indian companies such as Hetero Labs and Aurobindo Pharma for loratadine and pseudoephedrine, and Chinese firms like Zhejiang Medicine. These manufacturers meet international quality standards to supply global markets.

2. Can generic versions of CLARINEX-D 12 HOUR be sourced locally?
Yes, multiple generic manufacturers in regions like India and Europe produce CLARINEX-D 12 HOUR, often relying on APIs from prominent Chinese or Indian producers, with licensing and regulatory approval governing market availability.

3. How do regulatory agencies impact supplier selection?
Regulatory agencies enforce GMP compliance. Suppliers must maintain certifications (e.g., ISO, FDA approval) to be deemed reliable, affecting procurement decisions and supply chain stability.

4. Are there risks associated with sourcing from Chinese API manufacturers?
Yes, although many Chinese suppliers adhere to strict standards, risks include regulatory scrutiny, quality variation, and geopolitical restrictions. Due diligence and supplier audits are essential.

5. What strategies can companies use to mitigate supply chain risks?
Diversification of API sources, establishing relationships with multiple suppliers, maintaining inventory buffers, and adhering to stringent quality controls are effective strategies.

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Sources

1. MSD official product information and licensing data.
2. Global API supplier directories and certifications (e.g., U.S. FDA, EMA databases).
3. Industry reports on generic pharmaceutical supply chains (e.g., IQVIA, IMS Health).
4. Regulatory agency publications on API manufacturing standards.
5. Public disclosures from Indian and Chinese API producers.

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