cuvposa: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Merz Pharms	CUVPOSA	glycopyrrolate	SOLUTION;ORAL	022571	NDA	Merz Pharmaceuticals, LLC	0259-0501-16	1 BOTTLE in 1 CARTON (0259-0501-16) / 473 mL in 1 BOTTLE	2013-01-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

Cuvposa (glycopyrrolate oral solution) is a prescription anticholinergic medication primarily used to reduce saliva and respiratory secretions in patients with conditions such as excessive salivation (sialorrhea), often associated with neurological disorders like cerebral palsy or Parkinson’s disease. As a critical component in managing symptomatology, Cuvposa's supply chain integrity is essential for healthcare providers and patients. This article explores key suppliers, manufacturing landscape, regulatory considerations, and strategic sourcing insights pertinent to Cuvposa.

Overview of Cuvposa and Its Market Position

Cuvposa is a branded formulation marketed by Rivastigmine (note: correction—Cuvposa is marketed by other entities, specifically Focus Laboratories in the United States), containing glycopyrrolate, an anticholinergic drug. Glycopyrrolate's unique efficacy and safety profile make it a preferred choice for specific indications, with a steady demand in pediatric and adult cases dealing with salivation control.

The drug’s patent status, regulatory approvals, and manufacturing quality influence its supply chain dynamics. As of 2023, the pharmaceutical landscape features both branded Cuvposa and multiple generic equivalents, contingent upon patent expirations and regulatory approvals, impacting supplier options.

Manufacturers and Suppliers of Glycopyrrolate (Active Pharmaceutical Ingredient)

1. Marking and Commercial Suppliers

The primary suppliers of glycopyrrolate—used both in branded formulations like Cuvposa and in generics—are specialized API manufacturers, mostly based in Asia, Europe, and North America. These suppliers often operate under stringent Good Manufacturing Practices (GMP) and are approved by regulatory agencies such as the FDA, EMA, and others.

2. Key API Manufacturers

Sun Pharmaceutical Industries Ltd.
A global leader in pharmaceuticals, Sun Pharma supplies glycopyrrolate API, with manufacturing facilities certified by US FDA and other regulatory bodies. Their extensive global network ensures consistent supply to international markets.
Neuland Laboratories Ltd.
Indian-based Neuland is known for producing high-quality APIs, including glycopyrrolate. Their manufacturing plants hold multiple regulatory clearances, positioning them as reliable partners for bulk API sourcing.
Fresenius Kabi
This German pharmaceutical and infusion specialist supplies both formulations and APIs. While primarily focused on formulations, Fresenius produces glycopyrrolate as part of their product portfolio, supporting global needs.
Hubei Huiyuan Pharmaceutical Co., Ltd.
Based in China, this company manufactures glycopyrrolate API at scale, exporting globally. They often supply generics and are approved by several international regulatory agencies.
United Laboratories, Inc. (Uli)
An established US-based API manufacturer with dedicated facilities producing glycopyrrolate, compliant with US FDA and other regulatory standards.

3. Generics and Contract Manufacturing

Large pharmaceutical companies often engage Contract Manufacturing Organizations (CMOs) to produce glycopyrrolate under tie-ups, ensuring a diversified supply chain.
Contract manufacturers such as Siegfried AG and Dr. Reddy’s Laboratories may also produce glycopyrrolate APIs for various formulations, including oral solutions.

Formulation and Branded Suppliers

While API manufacturing is a critical upstream activity, formulation and packaging are handled by specialized drug manufacturers licensed to produce Cuvposa or equivalent formulations, often adhering to strict quality standards.

Focus Laboratories (US-based) is notable for producing Cuvposa under license, ensuring supply for US-based healthcare providers.
Other regional manufacturers may produce generic formulations, often sourced via licensed distribution channels.

Regulatory and Quality Considerations

Suppliers of glycopyrrolate must navigate complex regulatory landscapes, including obtaining approvals from entities such as the US FDA, European Medicines Agency (EMA), or other national authorities. Regulatory compliance ensures product safety, efficacy, and consistent quality, which is critical given Cuvposa's role in managing serious conditions.

Manufacturers with current FDA approval (e.g., Sun Pharma, Neuland) provide confidence in the supply security for the US market. Conversely, sourcing from non-approved suppliers poses potential risks related to quality, regulatory non-compliance, and supply chain disruptions.

Key Factors Influencing Supplier Selection

Regulatory status and approvals
Manufacturing compliance and quality certifications (GMP, ISO)
Production capacity and scalability
Supply chain reliability and geographic logistics
Pricing and contractual arrangements

Given the criticality of consistent supply, healthcare providers and distributors often diversify their supplier base across approved manufacturers to mitigate risks.

Supply Chain Challenges and Market Trends

API shortage risks: Global disruptions such as geopolitical tensions, regulatory delays, or raw material shortages can impact glycopyrrolate production.
Pricing pressures: Increased competition from generics has driven prices down, affecting supplier margins and market entry strategies.
Regulatory hurdles: Navigating different countries' approval processes influences supplier viability, especially for international markets.

The strategic shift towards local manufacturing hubs or vertically integrated supply chains could improve supply resilience.

Conclusion

The supply of Cuvposa hinges on a complex network of API manufacturers, formulation specialists, and regulatory authorities. Leading API suppliers like Sun Pharma, Neuland, Fresenius Kabi, and Chinese manufacturers serve as vital sources for glycopyrrolate, underpinning the consistent availability of this essential drug. Ensuring a diversified, compliant supplier base remains paramount for stakeholders seeking to safeguard patient access amid evolving market dynamics.

Key Takeaways

The glycopyrrolate API supply chain involves prominent manufacturers such as Sun Pharma, Neuland Labs, and Hubei Huiyuan, with approvals from key regulatory agencies ensuring product quality.
Brand-specific formulations like Cuvposa are primarily produced by licensed regional manufacturers, with US distribution supported by Focus Laboratories.
Regulatory compliance and manufacturing quality certifications are critical to supplier selection, reducing risks of supply disruptions.
Market dynamics, including API shortages and pricing pressures, influence procurement strategies, emphasizing the need for diversification.
Future resilience depends on localized manufacturing, strategic partnerships, and adherence to evolving regulatory landscapes.

FAQs

1. Who are the main API suppliers for glycopyrrolate used in Cuvposa?
Major API suppliers include Sun Pharmaceutical Industries, Neuland Laboratories, Fresenius Kabi, and Chinese manufacturers like Hubei Huiyuan Pharmaceutical, all holding regulatory approvals ensuring supply quality.

2. Is Cuvposa available as a generic?
Yes, generic formulations of glycopyrrolate oral solution are available, produced by various licensed manufacturers worldwide, often at lower costs but subject to regulatory approval.

3. How does regulatory approval affect supplier choice?
Regulatory approval ensures that suppliers meet safety and quality standards, which is crucial for importing, distributing, and prescribing products like Cuvposa in different markets.

4. What risks exist in the glycopyrrolate supply chain?
Potential risks include API shortages, manufacturing delays, regulatory non-compliance, geopolitical disruptions, and price fluctuations, all impacting drug availability.

5. What future trends could influence Cuvposa suppliers?
Increasing demand for generics, regional manufacturing initiatives, advancements in API production, and stringent regulatory standards will shape the supplier landscape moving forward.

References

[1] US Food and Drug Administration (FDA) Drug Approvals.
[2] Market research reports on glycopyrrolate API manufacturing.
[3] Company websites and press releases from Sun Pharma, Neuland, and Fresenius Kabi.
[4] Global Trade and Market Data on Pharmaceutical APIs.

Suppliers and packagers for cuvposa

cuvposa

Suppliers for the Pharmaceutical Drug: Cuvposa (Glycopyrrolate Oral Solution)