Suppliers and packagers for generic pharmaceutical drug: CABERGOLINE

CABERGOLINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal	CABERGOLINE	cabergoline	TABLET;ORAL	218618	ANDA	A-S Medication Solutions	50090-7642-0	8 TABLET in 1 BOTTLE (50090-7642-0)	2024-10-03
Amneal	CABERGOLINE	cabergoline	TABLET;ORAL	218618	ANDA	Amneal Pharmaceuticals NY LLC	69238-2693-1	8 TABLET in 1 BOTTLE (69238-2693-1)	2024-10-03
Amneal	CABERGOLINE	cabergoline	TABLET;ORAL	218618	ANDA	SKG Pharma Inc.	83085-003-08	8 TABLET in 1 BOTTLE (83085-003-08)	2024-07-05

Suppliers for the Pharmaceutical Drug: Cabergoline

Last updated: July 28, 2025

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Introduction

Cabergoline is a potent dopamine receptor agonist primarily prescribed for conditions related to hyperprolactinemia, Parkinson's disease, and certain pituitary tumors. Its efficacy hinges on the quality and reliability of its supply chain. As a high-demand medication with both branded and generic options, understanding the global landscape of suppliers—including key manufacturers, regional distribution channels, and regulatory considerations—is crucial for pharmaceutical companies, healthcare providers, and supply chain stakeholders.

This report offers a comprehensive overview of the primary suppliers for cabergoline, analyzing their manufacturing capabilities, regulatory status, and market presence to inform strategic procurement and compliance efforts.

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Global Manufacturing Landscape of Cabergoline

1. Original Manufacturers and Patents

Initially developed and marketed by licensed pharmaceutical companies, the original source of cabergoline was Sanofi-Aventis (now Aventis), which introduced the drug under the brand name Dostinex. Patents granted to Aventis protected the formulation for decades, ensuring exclusivity within licensed regions.

However, following patent expiration—most notably in the European Union and the United States—generic manufacturers gained the ability to produce cabergoline, significantly expanding its availability globally.

2. Generic Pharmaceutical Manufacturers

The current cabergoline supply chain is predominantly driven by generic pharmaceutical manufacturers. These firms operate across various regions, notably Asia, Europe, and North America, leveraging differing regulatory pathways to produce the drug. Key players include:

• Sun Pharmaceutical Industries Ltd. (India): One of the world's largest generics producers, Sun Pharma manufactures cabergoline under various labels, compliant with GMP standards and receiving approvals from major regulatory agencies such as the US FDA, EMA, and MHRA.

• Macleods Pharmaceuticals (India): Markets generic cabergoline with a strong regional presence, holding approvals in multiple markets, including North America and Europe.

• Torrent Pharmaceuticals (India): Also produces cabergoline, supplying both domestic and export markets, with certifications aligning with international quality standards.

• Apis Pharmaceuticals (USA): Licensed pharmaceutical manufacturers that produce generics meeting US pharmacopeia standards are crucial for US market supply.

• Teva Pharmaceutical Industries (Israel): Known for extensive generics manufacturing, Teva’s portfolio includes dopamine agonists such as cabergoline, with GMP compliance.

• Pharmaceutical Giants in Europe: Companies such as Sandoz (Novartis) and S.E. Le Pharma have manufacturing capabilities within Europe, distributing to EU markets. European regulatory approval ensures high-quality standards for their products.

3. Regional and Local Suppliers

Beyond global giants, regional producers hold significant market share in emerging economies:

• Alembic Pharmaceuticals (India): Provides affordable generics to Asian and African regions.

• Hikma Pharmaceuticals (UK/Jordan): Offers cabergoline formulations to Europe, Africa, and the Middle East.

• Herbal and traditional medicine companies occasionally produce complementary formulations but are not primary suppliers for approved pharmaceutical-grade cabergoline.

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Regulatory and Quality Considerations

1. Regulatory Approvals

Suppliers must secure approvals from major regulatory authorities to market cabergoline legally:

• US Food and Drug Administration (FDA): Ensures quality of generics through New Drug Applications (NDAs) or abbreviated pathways based on bioequivalence.

• European Medicines Agency (EMA): Certifies manufacturing sites under Good Manufacturing Practice (GMP) standards, approving marketing authorizations.

• World Health Organization (WHO): Provides prequalification for medicinal products, facilitating procurement for global health agencies.

2. Quality control and certifications

Suppliers adhering to GMP standards are critical. Internationally recognized certifications like ISO 9001 and adherence to pharmacopeial standards (USP, EP, JP) denote manufacturing quality. Many leading suppliers maintain rigorous testing and validation protocols, including:

• Stability testing

• Active pharmaceutical ingredient (API) purity assessments

• Contamination controls

3. Supply Chain and Risk Management

Dependence on regional suppliers introduces variability risks, such as geopolitical disruptions, regulatory shifts, and quality lapses. Diversification strategies and supplier audits are essential for continuity.

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Market Trends and Supply Chain Dynamics

1. Rising Demand

Growing awareness of prolactin-related conditions and Parkinson's disease underpins steady demand. Generic manufacturers have expanded their production capacities, ensuring ample supply.

2. Price Competition

Post-patent expiry, prices for cabergoline have decreased in global markets due to increased competition, making the drug more accessible but also intensifying market pressure on suppliers to maintain quality and compliance.

3. Regional Access Disparities

Emerging markets rely heavily on Indian and Chinese manufacturers, with quality assurance increasingly scrutinized by regulators and purchasers. Established suppliers with robust compliance histories are favored for large procurement contracts.

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Supply Chain Challenges

• Regulatory Hurdles: Ensuring products meet the specific standards of target markets can delay market entry or result in supply restrictions.

• Manufacturing Disruptions: Catastrophic events (e.g., natural disasters, pandemic impacts) affect production capabilities, emphasizing the need for diversified sourcing.

• Counterfeit Risks: The proliferation of falsified medicines necessitates strict procurement from certified suppliers with traceability.

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Conclusion

The supply of cabergoline is dominated by a mix of multinational generic manufacturers and regional suppliers. Leading global producers such as Sun Pharmaceutical Industries, Teva, and Sandoz maintain manufacturing sites compliant with international GMP standards, ensuring high-quality product availability.

Healthcare providers and procurement agencies should prioritize suppliers with robust regulatory approvals, transparent manufacturing practices, and diversified supply chains. Variability in regional standards necessitates meticulous qualification processes to mitigate risks associated with quality, supply continuity, and regulatory compliance.

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Key Takeaways

• The global cabergoline supply chain is primarily composed of Indian, European, and US-based generic pharmaceutical manufacturers, with the latter often serving regulated markets like the US.

• Regulatory compliance, GMP certification, and adherence to pharmacopeial standards are critical criteria in supplier qualification.

• Diversification of suppliers reduces the risk of disruption, especially in regions heavily reliant on a few key manufacturers.

• Price competition post-patent expiry has increased accessibility but underscored the importance of maintaining consistent quality standards.

• Monitoring regulatory developments and supply chain stability is essential for organizations relying on cabergoline, especially amid geopolitical and global health crises.

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FAQs

1. Who are the leading global suppliers of generic cabergoline?
Major manufacturers include Sun Pharmaceutical Industries (India), Teva Pharmaceuticals (Israel), Sandoz (Subsidiary of Novartis, Europe), and Macleods Pharmaceuticals (India). These companies produce GMP-certified formulations applicable in various regional markets.

2. How can I verify the quality of cabergoline from a supplier?
Verify the supplier's GMP compliance, regulatory approvals (FDA, EMA, WHO prequalification), and certification standards. Request batch testing reports and Certificates of Analysis (CoA) to confirm active ingredients' purity and stability.

3. Are there regional restrictions or regulations affecting cabergoline suppliers?
Yes. Each country has specific registration requirements, documentation, and certification standards. Suppliers must adapt their manufacturing and documentation processes to meet regional laws to legally distribute cabergoline.

4. How has patent expiration affected the cabergoline supply market?
Patent expiry has led to increased market competition, expanding the pool of manufacturers, lowering prices, and improving access, especially in developing regions. However, it also necessitates vigilant quality control.

5. What risks should organizations consider in sourcing cabergoline?
Risks include supply disruptions due to manufacturing issues, regulatory non-compliance, counterfeit products, and geopolitical instability. Implementing rigorous supplier qualification and diversification strategies mitigates these risks.

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References

[1] European Medicines Agency. Dostinex (cabergoline) EMA approval documentation.
[2] FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
[3] World Health Organization. Prequalification of Medicines Programme.
[4] Global data on pharmaceutical manufacturing capacities (IQVIA, February 2023).
[5] Industry reports on generic pharmaceutical market trends (Pharmaceutical Commerce, 2022).