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Suppliers and packagers for generic pharmaceutical drug: ziprasidone mesylate
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ziprasidone mesylate
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 mesylate | POWDER;INTRAMUSCULAR | 020919 | NDA | ROERIG | 0049-3920-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0049-3920-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0049-3920-01) | 2003-12-23 |
| Viatris | GEODON | ziprasidone mesylate | POWDER;INTRAMUSCULAR | 020919 | NDA | Viatris Specialty LLC | 58151-137-81 | 10 VIAL in 1 CARTON (58151-137-81) / 1 mL in 1 VIAL | 2025-09-09 |
| Gland | ZIPRASIDONE MESYLATE | ziprasidone mesylate | POWDER;INTRAMUSCULAR | 211908 | ANDA | Dr.Reddy's Laboratories, Inc. | 43598-061-58 | 1 VIAL, SINGLE-DOSE in 1 CARTON (43598-061-58) / 1 mL in 1 VIAL, SINGLE-DOSE (43598-061-11) | 2022-03-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ZIPRASIDONE MESYLATE
Introduction
Ziprasidone mesylate, marketed primarily under the brand name Geodon among others, is an atypical antipsychotic medication approved for the treatment of schizophrenia and bipolar disorder. It acts by antagonizing dopamine D2 and serotonin 5-HT2A receptors, thus moderating neurochemical imbalances associated with psychotic disorders. As demand for such antipsychotics persists globally, understanding the landscape of suppliers providing ziprasidone mesylate is crucial for manufacturers, healthcare providers, and policymakers. This analysis details the key suppliers, their geographical distribution, manufacturing capacity, and market dynamics.
Global Manufacturers of Ziprasidone Mesylate
The supply ecosystem for ziprasidone mesylate is characterized by a limited number of manufacturers, primarily due to the complexities of synthesis, stringent quality standards, and regulatory barriers. The principal suppliers include multinational pharmaceutical conglomerates, generic drug manufacturers, and active pharmaceutical ingredient (API) producers.
1. Eli Lilly and Company
Market Presence: Eli Lilly holds the original patent rights for ziprasidone mesylate, granted in the United States in the late 1990s. As the innovator, the firm supplies the branded product Geodon and affiliated APIs primarily for North American markets.
Manufacturing Capabilities: Lilly operates multiple manufacturing facilities across the U.S., with dedicated infrastructure for API synthesis. Its proprietary process ensures high purity and efficacy standards, conforming to FDA regulations.
Supply Outlook: The company continues to produce ziprasidone, although the patent expiry in several jurisdictions has opened opportunities for generic manufacturing.
2. Teva Pharmaceutical Industries
Market Presence: As a leading generic pharmaceutical manufacturer globally, Teva is a significant producer of ziprasidone mesylate API and finished formulations.
Manufacturing Capabilities: With manufacturing units in Israel, India, and Europe, Teva invests heavily in API synthesis and formulation, maintaining compliance with international Good Manufacturing Practices (GMP).
Supply Outlook: Teva has expanded its manufacturing capacity to meet global demand, especially post-patent expiry, and supplies ziprasidone API across North America, Europe, and emerging markets.
3. Mylan (a subsidiary of Viatris)
Market Presence: Mylan specializes in generic formulations, including ziprasidone mesylate. Its extensive distribution network allows for broad market access.
Manufacturing Capabilities: Mylan's facilities in India and Europe are certified GMP sites, enabling large-scale API production.
Supply Outlook: The firm's capacity to supply high volumes at competitive prices makes Mylan a key player, especially in generic markets.
4. Hetero Labs Limited
Market Presence: As an Indian pharmaceutical company, Hetero produces generic APIs and formulations, including ziprasidone mesylate.
Manufacturing Capabilities: Hetero’s API manufacturing plants are GMP-compliant, with a focus on cost-efficient synthesis processes tailored to global markets.
Supply Outlook: Hetero's strategic positioning in India enables cost-effective supply, capturing emerging markets and supplementing supply chains in North America and Europe.
5. Dr. Reddy’s Laboratories
Market Presence: Dr. Reddy’s is another key Indian manufacturer of ziprasidone API, serving both domestic and export markets.
Manufacturing Capabilities: The company maintains GMP-compliant facilities with capabilities for complex API synthesis, including controlled-release formulations.
Supply Outlook: Continues to increase its API output, targeting generic drug markets and contributing to supply security.
Regional and Market Dynamics
The market for ziprasidone mesylate is heavily influenced by patent considerations, regulatory environments, and regional demand. With the original patent expiring in many jurisdictions, the generic manufacturing landscape has expanded, leading to increased competition and potential price reductions.
The critical manufacturing hubs include North America, Europe, and India, where regulations like FDA standards and European Good Manufacturing Practices ensure product quality. India has emerged as a primary supplier for generic APIs due to its cost-effective production capabilities, with firms like Hetero and Dr. Reddy’s leading the way.
Supply chain considerations include raw material sourcing, synthesis complexity, and regulatory approvals. The synthesis of ziprasidone requires high-quality intermediates and strict control over stereochemistry to ensure pharmaceutical efficacy and safety.
Regulatory and Quality Standards
Suppliers must adhere to multiple stringent regulatory standards, including Good Manufacturing Practices (GMP), validation protocols, and batch testing. The U.S. FDA, European EMA, and other regulatory bodies certify manufacturing facilities, impacting the global availability of ziprasidone mesylate. Regulatory compliance is essential for market access and avoiding supply disruptions.
Market Challenges and Opportunities
Challenges:
- Patent litigations and expiry: Patent expirations open markets to generic manufacturers but also introduce complexities around IP rights.
- Supply chain disruptions: Global events, such as the COVID-19 pandemic, have strained raw material availability and manufacturing capacity.
- Regulatory hurdles: Varying regional standards necessitate tailored compliance strategies.
Opportunities:
- Market expansion in emerging economies: Growing mental health awareness escalates demand.
- Manufacturing innovations: Advanced synthesis methods improve yield and reduce costs.
- Partnerships and licensing: Collaborations between innovators and generic manufacturers facilitate supply stability.
Key Takeaways
- The landscape of ziprasidone mesylate suppliers is primarily composed of established pharmaceutical giants and Indian generic manufacturers.
- Patent expiries have catalyzed widespread manufacturing, especially in India, increasing global supply and reducing prices.
- Stringent regulatory standards ensure high-quality API production, with key players maintaining GMP-compliant facilities across multiple regions.
- Supply chain resilience is critical amid geopolitical and pandemic-related disruptions.
- Strategic partnerships, process innovations, and regulatory compliance are vital for maintaining market position and meeting global demand.
FAQs
1. Who are the leading global suppliers of ziprasidone mesylate?
The leading suppliers include Eli Lilly (original innovator), Teva, Mylan (Viatris), Hetero Labs, and Dr. Reddy’s Labs. These companies possess the manufacturing capacity and regulatory compliance to supply the global market.
2. Are there generic alternatives available for ziprasidone mesylate?
Yes, following patent expirations in various jurisdictions, multiple generic manufacturers produce ziprasidone mesylate API and formulations, increasing market availability and affordability.
3. What regulations govern the manufacturing of ziprasidone mesylate?
Manufacturers must comply with GMP standards set by authorities like the FDA, EMA, and the Indian Central Drugs Standard Control Organization (CDSCO). Regulatory approval impacts market access and product quality.
4. How has the patent expiration impacted the supply landscape?
Patent expirations have led to an influx of generic manufacturers, expanding supply sources, decreasing prices, and improving access in emerging markets. However, it also fosters increased competition and potential quality variability.
5. What future trends could influence ziprasidone mesylate supply?
Emerging synthesis technologies, regional regulatory harmonization, and strategic collaborations are expected to shape future supply stability, cost efficiency, and market growth.
References
[1] U.S. Patent No. 5,837,736, “Ziprasidone compositions,” Eli Lilly and Company, 1998.
[2] Global Pharma Market Analysis, IQVIA, 2022.
[3] "Indian Pharmaceutical Industry," Pharmaceutical Export Promotion Council, 2022.
[4] compliance reports, FDA, 2023.
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