Suppliers and packagers for geodon

geodon

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825	NDA	ROERIG	0049-0056-60	60 CAPSULE in 1 BOTTLE (0049-0056-60)	2019-08-01
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825	NDA	ROERIG	0049-0058-60	60 CAPSULE in 1 BOTTLE (0049-0058-60)	2019-08-01
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825	NDA	ROERIG	0049-0352-60	60 CAPSULE in 1 BOTTLE (0049-0352-60)	2021-11-08
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825	NDA	ROERIG	0049-0354-60	60 CAPSULE in 1 BOTTLE (0049-0354-60)	2023-07-14

Suppliers for the Pharmaceutical Drug: Geodon

Last updated: July 30, 2025

Introduction
Geodon (generic name: ziprasidone) is an atypical antipsychotic medication primarily prescribed to manage schizophrenia and bipolar disorder. Since its approval by the U.S. Food and Drug Administration (FDA) in 2001, Geodon has become a significant asset in psychiatric treatment protocols. The drug’s commercial availability hinges on a network of reputable suppliers that ensure consistent quality, supply chain integrity, and regulatory compliance. This comprehensive overview identifies major suppliers of Geodon, examines their roles within the pharmaceutical supply chain, and highlights implications for stakeholders.

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Manufacturers and Primary Suppliers of Geodon
The original formulation of Geodon was developed and marketed by Pfizer Inc., one of the leading pharmaceutical companies globally. As the patent-holder, Pfizer historically maintained manufacturing rights and distribution channels for Geodon. However, following patent expiration in December 2020, generic manufacturers have entered the market, increasing accessibility and competition.

1. Pfizer Inc.
As the originator, Pfizer holds the initial manufacturing rights for Geodon. Its production facilities are compliant with Good Manufacturing Practices (GMP) aligning with FDA regulations. Pfizer’s role extended beyond manufacturing to include research, development, and global distribution. Post-patent expiry, Pfizer's exclusivity diminished, which allowed generics to proliferate.

2. Generic Manufacturers
The expiration of Pfizer’s patent triggered increased participation by generic pharmaceutical firms. These manufacturers produce bioequivalent versions of ziprasidone, significantly altering the supply landscape. Key players include:

• Teva Pharmaceutical Industries Ltd.
  A global leader in generic medicines, Teva began producing ziprasidone shortly after patent expiry. Their extensive manufacturing network and adherence to regulatory standards make them a prominent supplier.

• Sun Pharmaceutical Industries Ltd.
  As one of India’s dominant generics producers, Sun Pharma secured approval for generic ziprasidone and distributes it across various markets, including the U.S.

• Zydus Cadila
  An Indian-based pharmaceutical firm, Zydus received approval for biosimilar versions of ziprasidone, expanding supply sources globally.

• Lupin Limited
  Another major Indian pharma company, Lupin developed and marketed generic ziprasidone in multiple jurisdictions.

• Mylan N.V. (now part of Viatris)
  Mylan was among the first to introduce a generic version of Geodon, leveraging an established manufacturing platform.

These manufacturers have established manufacturing plants compliant with international standards, and their supply chains are reinforced through regulatory audits and quality assurance systems.

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Regulatory Approvals & Market Distribution
The entry of generics into the Geodon market heavily depends on regulatory approvals from agencies such as the FDA, European Medicines Agency (EMA), and other national bodies. These agencies evaluate manufacturing processes, bioequivalence data, and safety profiles before approving generic versions.

Post-approval, the distribution network involves wholesale pharmaceutical distributors, hospital pharmacies, and retail outlets. Major distributors include McKesson, Cardinal Health, and AmerisourceBergen, which serve as intermediaries ensuring nationwide (and international) availability.

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Supply Chain Considerations & Challenges
The supply chain for Geodon involves complex procurement of raw materials, active pharmaceutical ingredients (API), and excipients. The API – ziprasidone hydrochloride – is synthesized primarily in India and China, where most generic suppliers source their raw materials.

Supply disruptions can arise from:

• Raw Material Shortages: Political, logistical, or industrial issues affecting API production in India and China.

• Regulatory Hurdles: Variations in approval processes or compliance issues across jurisdictions.

• Market Competition: Increased competition among generic manufacturers can lead to price pressures and supply volatility.

• Quality Control: Maintaining GMP standards across multiple manufacturers is essential to prevent issues such as contamination, which can lead to recalls or shortages.

Quality assurance and regulatory compliance are critical to maintaining a stable supply of Geodon. Pharmaceutical companies rely on rigorous audits, batch testing, and international standards to mitigate risks.

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Market Dynamics and Future Outlook
As the global demand for psychiatric medications increases, the supply of generic ziprasidone is expected to remain robust. The entry of multiple manufacturers has contributed to price stabilization and improved accessibility.

Emerging markets, particularly in Asia and Latin America, present new opportunities for suppliers to expand their distribution networks. Furthermore, patent expiry has encouraged innovation in formulations, including long-acting injectables and generic combination therapies.

Continued regulatory scrutiny and quality compliance will shape future supply strategies. Additionally, the development of biosimilars and alternative delivery systems could influence the prevalence of Geodon in psychiatric treatment regimens.

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Implications for Stakeholders
For healthcare providers, understanding the landscape of suppliers ensures confidence in product quality and availability. Pharmacists and procurement managers should consider manufacturer reputation, supply stability, and compliance history when sourcing Geodon.

Investors analyzing pharmaceutical companies involved in Geodon production should monitor regulatory developments, market share, and supply chain resilience. Policymakers and regulators play a pivotal role in maintaining supply integrity through vigilant oversight and standardized approvals.

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Key Takeaways

• Pfizer initiated the production of Geodon; subsequent patent expiry opened markets for multiple generic manufacturers such as Teva, Sun Pharma, and Lupin.
• The global supply chain heavily depends on API sourcing from India and China, emphasizing the importance of regulatory compliance and quality control.
• Market competition has driven price reductions and increased accessibility, but supply disruptions require rigorous oversight.
• The landscape is evolving with potential future innovations and increased penetration in emerging markets.
• Stakeholders must prioritize quality assurance, regulatory adherence, and supply chain transparency to ensure continual access.

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FAQs

1. Who are the main manufacturers of generic Geodon?
Teva, Sun Pharma, Zydus Cadila, Lupin, and Viatris (formerly Mylan) are notable generic producers post-patent expiration, each complying with international quality standards.

2. How does patent expiry impact the supply of Geodon?
Patent expiry allows generic manufacturers to produce bioequivalent versions, increasing supply options, reducing prices, and enhancing market access.

3. What are the primary risks to Geodon's supply chain?
Risks include raw material shortages, regulatory hurdles, manufacturing quality issues, and geopolitical disruptions affecting API sourcing.

4. How do regulatory agencies influence the supply of Geodon?
Agencies like the FDA approve manufacturing facilities and generic formulations, ensuring safety and quality, which directly affects market availability.

5. What should healthcare providers consider when sourcing Geodon?
Providers should evaluate manufacturer reputation, compliance records, product bioequivalence, and supply stability to ensure patient safety and consistent availability.

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References
[1] FDA. (2020). Approval of generic ziprasidone.
[2] Teva Pharmaceuticals. (2022). Product information for ziprasidone.
[3] Sun Pharmaceutical. (2022). Generic ziprasidone approval details.
[4] Zydus Cadila. (2022). Regulatory approvals for ziprasidone.
[5] Lupin Limited. (2022). Market release of generic ziprasidone.