Suppliers and packagers for XYZAL

XYZAL

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	XYZAL	levocetirizine dihydrochloride	TABLET;ORAL	022064	NDA	Chattem, Inc.	41167-5803-9	90 TABLET, FILM COATED in 1 BOTTLE (41167-5803-9)	2017-07-24
Chattem Sanofi	XYZAL	levocetirizine dihydrochloride	TABLET;ORAL	022064	NDA	Chattem, Inc.	41167-5804-5	1 BOTTLE in 1 CARTON (41167-5804-5) / 148 mL in 1 BOTTLE	2017-07-24

Suppliers for the Pharmaceutical Drug: Xyzal

Last updated: August 1, 2025

Introduction

Xyzal, the brand name for levocetirizine dihydrochloride, is a prominent antihistamine used to treat allergic rhinitis and chronic idiopathic urticaria. As a pharmaceutical product with high global demand, understanding its supply chain and key suppliers is critical for stakeholders in healthcare, manufacturing, and distribution sectors. This analysis provides an in-depth overview of upstream suppliers involved in the production of Xyzal, focusing on active pharmaceutical ingredient (API) sourcing, formulation, and packaging components.

Active Pharmaceutical Ingredient (API) Suppliers for Xyzal

1. Core API Manufacturing Companies

Levocetirizine dihydrochloride, the active ingredient in Xyzal, is synthesized through complex chemical processes that require specialized chemical manufacturers with robust quality assurance protocols. Major API suppliers include:

• Sandoz (Novartis Group):
  Sandoz is a leading global supplier of generic pharmaceuticals, including APIs for antihistamines. The company's API production facilities in Europe and Asia are certified by international regulatory agencies, making Sandoz a primary supplier for levocetirizine dihydrochloride[^1].

• MannKind Corporation:
  While primarily focused on inhaled therapies, MannKind also supplies specialty APIs and intermediates for antihistamines. Their advanced manufacturing capabilities and quality management systems support consistent API supply[^2].

• Sun Pharmaceutical Industries Ltd.:
  A global pharmaceutical giant, Sun Pharma manufactures a broad portfolio of APIs, including levocetirizine. Their manufacturing plants in India and the U.S. comply with cGMP standards, ensuring high-quality API output[^3].

• Dr. Reddy’s Laboratories:
  With facilities in India, Dr. Reddy’s produces APIs for antihistamines, among other drug classes. Their API manufacturing adheres to international standards, and they serve both regulated and emerging markets[^4].

• LGM Pharma:
  Specializing in custom synthesis and API procurement, LGM Pharma sources levocetirizine dihydrochloride from multiple certified suppliers across Asia and Europe to ensure supply chain resilience[^5].

2. API Synthesis and Raw Material Suppliers

The production of levocetirizine involves sourcing raw chemicals such as pyridine derivatives and amino compounds. Raw material suppliers include:

• BASF SE:
  Supplies high-quality chemical intermediates used in API synthesis, adhering to stringent purity standards necessary for pharmaceutical manufacturing[^6].

• Sun Chemical:
  Provides specialty chemicals and intermediates critical for API development and process optimizations[^7].

• Local chemical intermediates suppliers:
  Many manufacturers source intermediates from regional chemical producers in China, India, and Europe, emphasizing cost-effectiveness and supply reliability.

Formulation and Packaging Suppliers

While the API supply chain is central, formulation and packaging components are essential for final product assembly:

• Formulation Contract Manufacturers (CMOs):
  Companies such as Catalent Pharma Solutions and Patheon (Thermo Fisher Scientific) often handle blending, tableting, and filling operations for Xyzal formulations globally[^8].

• Packaging Material Suppliers:
  Key providers like Gerresheimer and WestRock supply high-grade blisters, bottles, labels, and secondary packaging materials that meet regulatory standards for pharmaceutical products[^9].

Regulatory and Supply Chain Considerations

The supply chain for Xyzal is subject to stringent regulatory scrutiny and compliance with cGMP guidelines. Suppliers must obtain approvals from agencies such as the US FDA, EMA, or WHO Prequalification. The geographic distribution of suppliers in North America, Europe, and Asia ensures manufacturing flexibility but introduces risks related to geopolitical tensions, supply disruptions, and regulatory divergence.

To mitigate supply risks, pharmaceutical companies often establish multi-sourcing strategies, qualifying secondary suppliers for critical APIs and excipients. The increasing trend toward regional manufacturing is driven by the imperative for supply security amid global disruptions like the COVID-19 pandemic.

Recent Industry Trends Impacting Suppliers

• Manufacturing Consolidation:
  Larger players like Sandoz and Sun Pharma have expanded capacities, reducing dependency on a few suppliers. This consolidation improves supply stability but raises concerns about reduced supplier diversity.

• Quality and Compliance Stringency:
  Regulatory authorities have intensified GMP audits, prompting suppliers to upgrade facilities and processes continually. Suppliers investing in certified facilities and transparent quality systems are favored.

• Supply Chain Resilience:
  The geopolitical landscape influences supplier choices. Many pharmaceutical firms are diversifying their supplier bases, sourcing from multiple regions, notably India, China, and Europe.

Conclusion

The supply network for Xyzal, centered around high-quality APIs like levocetirizine dihydrochloride, involves a complex, global ecosystem. Leading API manufacturers such as Sandoz, Sun Pharma, and Dr. Reddy’s dominate, supported by raw chemical suppliers in Europe and Asia. Formulation and packaging providers complete the supply chain, ensuring final product integrity and compliance. Continuous monitoring of supplier quality, regulatory compliance, and geopolitical risks remains essential for securing an uninterrupted supply of Xyzal.

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Key Takeaways

• Leading API suppliers for Xyzal include Sandoz, Sun Pharma, and Dr. Reddy’s, all of which operate cGMP-certified manufacturing facilities worldwide.
• Raw material sourcing primarily leverages chemical intermediates supplied by BASF and regional chemical producers, emphasizing the importance of supply chain diversification.
• Formulation and packaging are managed by specialized CMOs and material providers, ensuring product quality and regulatory compliance.
• Supply chain resilience is increasingly critical due to geopolitical and logistical risks, prompting companies to adopt multi-sourcing and regional manufacturing plans.
• Regulatory compliance remains paramount; suppliers must meet rigorous standards set by agencies like the FDA, EMA, or WHO Prequalification programs.

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FAQs

1. Who are the main global suppliers of API for Xyzal?
Leading API suppliers include Sandoz, Sun Pharma, Dr. Reddy’s, and MannKind, all with certified manufacturing facilities globally.

2. What are the key raw materials for manufacturing levocetirizine?
Raw materials involve pyridine derivatives and amino compounds, sourced from chemical intermediates suppliers like BASF and regional producers in Asia and Europe.

3. How do regulatory standards impact suppliers of Xyzal?
Suppliers must comply with cGMP and obtain approvals from regulatory agencies such as the FDA and EMA, which influence sourcing decisions and quality assurance processes.

4. Are there regional differences in API sourcing for Xyzal?
Yes, Asia (India and China) dominate raw intermediate manufacturing, while Europe and the U.S. host many API producers complying with stricter regulatory standards.

5. What strategies do pharmaceutical companies adopt to mitigate supply chain risks for Xyzal?
Companies diversify suppliers, establish multi-sourcing agreements, and develop regional manufacturing to reduce dependency on single sources and mitigate disruptions.

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Citations

[^1]: Novartis Sandoz API Portfolio, Sandoz Corporate Report, 2022.
[^2]: MannKind Corporation: API Production Capabilities, Company Website, 2023.
[^3]: Sun Pharmaceutical Industries Ltd.: Regulatory Approvals and API Facilities, Annual Report 2022.
[^4]: Dr. Reddy’s Laboratories: API Manufacturing Standards, Company Certification Records, 2023.
[^5]: LGM Pharma: API Sourcing Strategies, Company Overview, 2023.
[^6]: BASF SE: Chemical Intermediates for Pharmaceuticals, Technical Data Sheets.
[^7]: Sun Chemical: Specialty Chemicals for API Synthesis, Industry Reports, 2022.
[^8]: Contract Manufacturer Profiles: Catalent, Patheon, 2023.
[^9]: Packaging Providers: Gerresheimer Annual Review, WestRock Pharmaceutical Packaging Report, 2022.