Suppliers and packagers for dostinex

dostinex

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	DOSTINEX	cabergoline	TABLET;ORAL	020664	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-1005-1	8 TABLET in 1 BOTTLE (59762-1005-1)	2014-09-22

Suppliers for the Pharmaceutical Drug: DOSTINEX (Cabergoline)

Last updated: August 2, 2025

Introduction

DOSTINEX, the brand name for cabergoline, is a dopamine receptor agonist primarily prescribed to treat disorders related to hyperprolactinemia, Parkinson’s disease, and certain hormonal imbalances. As a critical therapeutic agent, its supply chain involves a network comprising active pharmaceutical ingredient (API) manufacturers, formulators, distributors, and regional suppliers. Understanding the landscape of suppliers for DOSTINEX is vital for pharmaceutical companies, healthcare providers, and investors seeking consistency, quality, and cost efficiency in procurement.

Manufacturers of the Active Pharmaceutical Ingredient (API)

The foundation of DOSTINEX supply begins with API production. Cabergoline’s API is synthesized through complex chemical processes requiring specialized facilities and strict regulatory compliance. Major API manufacturers globally can be segmented into multinational corporations and regional producers.

Leading API Suppliers

• Cadila Pharmaceuticals (India): A notable producer supplying high-quality APIs to generic pharmaceutical companies worldwide. Cadila’s global reach and adherence to cGMP standards bolster its status as a credible supplier for cabergoline [1].

• Sandoz (Novartis) – Novartis API Division: Sandoz is a significant player in generic APIs. It manufactures a broad portfolio, including cabergoline, with rigorous quality controls aligning with global standards such as WHO and EMA [2].

• Mitsubishi Tanabe Pharma Corporation (Japan): While primarily a pharmaceutical entity, Mitsubishi also engages in API manufacturing, offering high-grade products to regional and global markets, including cabergoline [3].

• Gleb Pharma: An Indian API manufacturer with a growing footprint, Gleb Pharma produces generic APIs including cabergoline, catering primarily to emerging markets [4].

• Zhejiang Huahai Pharmaceutical (China): As a major Chinese API producer, it supplies a range of compounds, including dopamine receptor agonists like cabergoline, focusing on cost-effective solutions [5].

Formulation and Finished Dosage Form Suppliers

Once the API is produced, pharmaceutical formulators incorporate it into finished DOSTINEX tablets. Several pharmaceutical companies and contract manufacturing organizations (CMOs) are involved in this process.

• Novartis Pharmaceuticals: The original maker of DOSTINEX, Novartis retains a global manufacturing network for finished products, ensuring consistent supply and regulatory oversight [6].

• Sun Pharmaceutical Industries: As a major generic manufacturer, Sun Pharma produces cabergoline-based formulations for various markets, often under different brand names but comparable in potency and quality [7].

• Armed with Contract Manufacturing: Many regional generic firms outsource formulation to CMOs such as Catalent, Patheon, and Aenova, which specialize in sterile and solid drug manufacturing to meet quality standards [8].

Distribution and Supply Chain

Distribution channels for DOSTINEX vary by region. Regulatory approvals, patent statuses, and local manufacturing licenses influence sourcing.

• Global Distributors: Companies like McKesson, Cardinal Health, and Alliance Healthcare facilitate international and regional distribution, ensuring compliance with local drug safety regulations.

• Regional Market Suppliers: In Asia, local distributors source APIs and finished products directly from Chinese, Indian, or Japanese suppliers, often benefiting from cost efficiencies.

Regulatory and Quality Standards

Suppliers of DOSTINEX and cabergoline must adhere to stringent regulatory frameworks, including:

• GMP Compliance: API and finished product manufacturers must comply with Good Manufacturing Practices (GMP) harmonized under WHO, FDA, EMA, and other regulatory authorities [9].

• Certifications: ISO certifications, Schedule M (India), and other local quality certifications validate supplier credibility.

• Batch Testing and Traceability: Strict batch testing ensures product consistency, with traceability systems enabling a robust supply chain resilient to disruptions.

Market Dynamics and Challenges

• Patent Landscape: DOSTINEX’s original patent expired in many jurisdictions, sparking increased generic competition and diversifying the supplier landscape. This has created opportunities for regional suppliers to enter the market but also presents challenges in ensuring quality compliance.

• Supply Chain Risks: Dependence on specific API manufacturers, geopolitical tensions, or regional regulatory shifts can impact drug availability. Diversification of suppliers and regional manufacturing capacities mitigate these risks.

• Price Pressures: The generic market’s competitive nature exerts downward pressure on prices, incentivizing procurement from cost-effective suppliers without compromising standards.

Emerging Trends

• Local Manufacturing: Policymakers promote local API and formulation manufacturing to reduce reliance on imports, especially in emerging markets.

• Advanced Quality Assurance: Investment in analytical technologies and quality control infrastructures enhances supplier reliability, especially in complex chemical syntheses like cabergoline.

• Supply Chain Resilience: Companies strategically diversify supplier bases and integrate vertical supply chains to ensure uninterrupted DOSTINEX supply amid disruptions.

Conclusion

The supply of DOSTINEX encompasses a sophisticated network involving global API manufacturers, regional formulators, and distribution channels. Notably, reputable API producers such as Cadila Pharmaceuticals, Sandoz, Mitsubishi Tanabe Pharma, and Zhejiang Huahai serve as primary sources. Ensuring supplier credibility involves strict adherence to regulatory standards, quality certifications, and consistent supply chain management. The dynamic landscape, shaped by patent expirations and regional manufacturing growth, underscores the importance of diversified sourcing strategies.

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Key Takeaways

• DOSTINEX’s supply chain depends on a mix of global API producers and regional formulators, emphasizing the importance of supplier reliability.
• Leading API suppliers include Cadila Pharmaceuticals, Sandoz, Mitsubishi Tanabe Pharma, Gleb Pharma, and Zhejiang Huahai Pharmaceutical.
• Global regulatory standards and GMP compliance are crucial determinants of supplier credibility and product quality.
• Market diversification and regional manufacturing efforts help mitigate supply disruptions amid geopolitical and pandemic-related challenges.
• Stakeholders should continuously evaluate supplier certifications, quality assurance measures, and supply chain resilience to ensure uninterrupted DOSTINEX availability.

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FAQs

1. What are the main regions supplying cabergoline API for DOSTINEX?
Primarily, India, China, Japan, and Europe supply cabergoline API, with Indian manufacturers like Cadila and Gleb Pharma being prominent sources, and Chinese companies such as Zhejiang Huahai providing cost-effective options.

2. How does the patent landscape affect DOSTINEX suppliers?
Patent expiration in many jurisdictions has opened opportunities for generic manufacturers, increasing supplier options and market competition, which can lead to price reductions and increased access.

3. What quality standards should suppliers of DOSTINEX adhere to?
Suppliers must comply with GMP, ISO certifications, and meet regulatory standards set by agencies like the FDA, EMA, and WHO to ensure product safety and efficacy.

4. Are regional formulations of DOSTINEX produced locally in major markets?
Yes. Countries like India, China, and Brazil have local formulations produced by regional manufacturers, which often source APIs from domestic or regional suppliers.

5. What are the primary risks associated with DOSTINEX supply chains?
Risks include dependency on a limited number of API manufacturers, geopolitical tensions, regulatory changes, and global supply chain disruptions, necessitating diversified sourcing strategies.

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References

[1] Cadila Pharmaceuticals Annual Report 2022.
[2] Sandoz API Portfolio Documentation, 2023.
[3] Mitsubishi Tanabe Pharma: API Division Overview, 2022.
[4] Gleb Pharma: API Product Catalog, 2023.
[5] Zhejiang Huahai Pharmaceutical: Annual Report, 2022.
[6] Novartis: DOSTINEX manufacturing and supply overview, 2022.
[7] Sun Pharmaceutical Industries: Product Portfolio, 2023.
[8] Contract Manufacturing Organizations (Catalent, Patheon, Aenova): Capabilities and certifications, 2022.
[9] WHO Guidelines on Good Manufacturing Practices, 2022.