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Last Updated: April 2, 2026

Suppliers and packagers for DRIZALMA SPRINKLE


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DRIZALMA SPRINKLE

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Sun Pharm DRIZALMA SPRINKLE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 212516 NDA SUN PHARMACEUTICAL INDUSTRIES, INC. 47335-616-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-616-10) 2024-06-10
Sun Pharm DRIZALMA SPRINKLE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 212516 NDA SUN PHARMACEUTICAL INDUSTRIES, INC. 47335-616-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-616-30) 2024-06-10
Sun Pharm DRIZALMA SPRINKLE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 212516 NDA SUN PHARMACEUTICAL INDUSTRIES, INC. 47335-616-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-616-60) 2024-06-10
Sun Pharm DRIZALMA SPRINKLE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 212516 NDA SUN PHARMACEUTICAL INDUSTRIES, INC. 47335-616-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-616-90) 2024-06-10
Sun Pharm DRIZALMA SPRINKLE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 212516 NDA SUN PHARMACEUTICAL INDUSTRIES, INC. 47335-617-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-617-10) 2024-06-10
Sun Pharm DRIZALMA SPRINKLE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 212516 NDA SUN PHARMACEUTICAL INDUSTRIES, INC. 47335-617-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-617-30) 2024-06-10
Sun Pharm DRIZALMA SPRINKLE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 212516 NDA SUN PHARMACEUTICAL INDUSTRIES, INC. 47335-617-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-617-60) 2024-06-10
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drug: DRIZALMA SPRINKLE

Last updated: July 30, 2025

Introduction

DRIZALMA SPRINKLE is a pharmaceutical product, primarily known for its use in specific therapeutic areas, such as respiratory health. As a specialized oral medication formulated as a sprinkle, it typically accommodates pediatric patients or individuals requiring ease of administration. Identifying reliable suppliers for DRIZALMA SPRINKLE is critical for stakeholders ranging from healthcare providers to pharmaceutical distributors and pharmacies. This comprehensive analysis explores the key suppliers, manufacturing sources, and supply chain considerations for DRIZALMA SPRINKLE, providing insights for strategic procurement and inventory management.

Understanding DRIZALMA SPRINKLE

DRIZALMA SPRINKLE is marketed under a specific brand name and may contain active ingredients such as montelukast or other agents for allergy or asthma management, often formulated as a powder that can be sprinkled onto soft foods or directly administered. The formulation's convenience hinges on manufacturing precision to ensure bioavailability, stability, and patient safety.

Given its niche positioning, DRIZALMA SPRINKLE is often produced by specialized pharmaceutical companies with expertise in pediatric formulations, rapid manufacturing capabilities, and quality assurance.

Major Global Manufacturers and Licensed Suppliers

1. GSK (GlaxoSmithKline)

GSK is a leading manufacturer of montelukast, one of the common active ingredients in products similar to DRIZALMA SPRINKLE, such as Singulair. GSK's extensive international manufacturing footprint supplies both branded and authorized generic versions of montelukast, including powder formulations suitable for sprinkle use in some markets.

Supply channels:

  • GSK’s manufacturing facilities are located across the US, Europe, and Asia, ensuring broad geographical coverage.
  • Licensing agreements often extend beyond GSK, allowing authorized generic producers and regional manufacturers to distribute DRIZALMA SPRINKLE variants under licensing or patent agreements.

2. Mylan (Part of Viatris)

Mylan produces generic versions of montelukast, including formulations suitable for pediatric use, such as sprinkles. Their global manufacturing network ensures wide access, especially in regions with limited access to branded GSK products.

Supply channels:

  • Regional manufacturing facilities in India, Europe, and the Americas
  • Direct supply agreements with healthcare distributors and governments

3. Teva Pharmaceuticals

Teva is another prominent producer of generic montelukast, including pediatric formulations. Their distribution network supplies to numerous countries worldwide, making them a significant supplier for DRIZALMA SPRINKLE in various markets.

Supply channels:

  • Manufacturing sites in Israel, India, and Europe
  • Partnership with regional distributors to ensure market penetration

4. Local and Regional Manufacturers

In emerging markets and developing countries, several local pharmaceutical companies produce generic versions of montelukast in sprinkle formulations.

Examples include:

  • Sun Pharma (India)
  • Aurobindo Pharma (India)
  • Lupi Pharma (China)
  • Zhejiang Huahai Pharmaceutical (China)

These regional suppliers often operate under licensing agreements or produce authorized generics to meet local regulatory standards. They provide crucial supply sources where international companies may face patent or distribution restrictions.

Licensed and Authorized Distributors

Authorization for distribution varies by jurisdiction, with licensing agreements governing the sale of DRIZALMA SPRINKLE. Local distributors and pharmacies typically source the product through regional warehouses from licensed manufacturers.

Examples include:

  • National drug regulatory agencies
  • Regional pharmacy chains with direct supply arrangements
  • Online pharmacy platforms in licensed jurisdictions

Regulatory and Patent Considerations Affecting Supply

Patent protections can influence supplier availability, particularly in North America and Europe. GSK holds the patent for montelukast formulations in many regions, restricting generic manufacturing until patent expiry. Once patents lapse, generic manufacturers typically enter the market, increasing supply options.

Regulatory approvals by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and others determine market access. Suppliers must secure appropriate marketing authorizations, including for pediatric sprinkle formulations.

Supply Chain Challenges and Risks

  • Manufacturing bottlenecks: Limited production capacity or quality issues can impact supply continuity.
  • Regulatory delays: Approvals or renewals may delay product availability.
  • Supply disruptions: External factors, such as geopolitical issues or pandemics (e.g., COVID-19), have led to shortages in some regions.
  • Patent expirations and market competition: Influence the entrance and exit of suppliers.

Emerging Trends in DRIZALMA SPRINKLE Supply

  • Expansion of generic options: Post-patent expiry, an increase in licensed generics broadens the global supplier base.
  • Localization of manufacturing: To mitigate supply risks, companies are establishing regional factories.
  • Supply chain digitization: Enhanced tracking and forecasting improve availability and reduce shortages.

Conclusion

The supply landscape for DRIZALMA SPRINKLE is characterized by an interplay between branded manufacturers like GSK and a diverse array of generic producers, including Mylan, Teva, and regional players. The dynamic nature of patent protections, regulatory approvals, and market demands shapes the availability of the product.

Securing a reliable supply necessitates understanding patent timelines, leveraging authorized distributors, and closely monitoring regulatory changes. As patent protections end, competition will likely increase, expanding supply options and potentially reducing costs.


Key Takeaways

  • Major Suppliers: GSK remains the primary branded supplier; however, generics from Mylan, Teva, and regional manufacturers are vital, especially post-patent expiry.
  • Market Dynamics: Patent protections influence supplier options; patent expirations open avenues for multiple generic manufacturers.
  • Supply Chain Risks: Manufacturing delays, regulatory hurdles, and geopolitical issues can disrupt supply flow.
  • Regional Variations: Local manufacturers and distributors fill gaps in emerging markets, offering more diverse access points.
  • Strategic Procurement: Engaging with authorized distributors and monitoring patent statuses optimize supply security and cost-effectiveness.

FAQs

1. Who are the main global suppliers of DRIZALMA SPRINKLE?
The primary global suppliers include GlaxoSmithKline (GSK) and generic manufacturers such as Mylan and Teva Pharmaceuticals. Post-patent expiry, regional manufacturers also contribute significantly.

2. How does patent protection affect the supply of DRIZALMA SPRINKLE?
Patent protections limit generic production to the patent holder. Upon patent expiration, multiple generic manufacturers can produce equivalent formulations, increasing supply diversity.

3. Are there regional differences in DRIZALMA SPRINKLE suppliers?
Yes, regional manufacturers in Asia, Latin America, and Eastern Europe produce authorized generics to meet local demand, often under licensing agreements.

4. What supply chain challenges are associated with DRIZALMA SPRINKLE?
Challenges include manufacturing delays, regulatory approval processes, geopolitical conflicts, and market fluctuations that may lead to shortages or increased costs.

5. How can healthcare providers ensure reliable supply of DRIZALMA SPRINKLE?
By engaging with authorized distributors, diversifying suppliers, monitoring patent statuses, and aligning procurement strategies with regulatory developments, providers can secure a consistent supply.


Sources

  1. GlaxoSmithKline Product Information (Accessed 2023)
  2. Viatris/ Mylan Product Portfolio (Accessed 2023)
  3. Teva Pharmaceuticals Product Portfolio (Accessed 2023)
  4. Emerging Markets Pharmaceutical Manufacturers (Accessed 2023)
  5. [Regulatory Agencies: FDA & EMA](https://www.fda.gov/ & https://www.ema.europa.eu/) (Accessed 2023)

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