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Suppliers and packagers for celexa
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celexa
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Abbvie | CELEXA | citalopram hydrobromide | TABLET;ORAL | 020822 | NDA | Allergan, Inc. | 0456-4010-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0456-4010-01) | 1998-07-17 |
| Abbvie | CELEXA | citalopram hydrobromide | TABLET;ORAL | 020822 | NDA | Allergan, Inc. | 0456-4020-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0456-4020-01) | 1998-07-17 |
| Abbvie | CELEXA | citalopram hydrobromide | TABLET;ORAL | 020822 | NDA | Allergan, Inc. | 0456-4040-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0456-4040-01) | 1998-07-17 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: CELEXA (Citalopram Hydrobromide)
Introduction
CELEXA, the brand name for citalopram hydrobromide, is a widely prescribed selective serotonin reuptake inhibitor (SSRI) used predominantly in the treatment of depression and anxiety disorders. First approved by the U.S. Food and Drug Administration (FDA) in 1998, CELEXA has become a staple in psychopharmacology, favored for its efficacy and safety profile. Its global market presence necessitates a complex supply chain involving multiple manufacturers, distributors, and authorized generics. This report explores the landscape of suppliers involved in the production, distribution, and licensing of CELEXA, providing insights essential for stakeholders ranging from healthcare providers to pharmaceutical investors.
Manufacturers of Active Pharmaceutical Ingredient (API): Citalopram Hydrobromide
Original API Producers
The supply of CELEXA hinges critically on the production of its active ingredient, citalopram hydrobromide. The original patent holder was Lundbeck, which developed and commercialized CELEXA. Post patent expiration in many jurisdictions, multiple generic manufacturers entered the market.
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Lundbeck: As the patent holder, Lundbeck originally manufactured the API and marketed CELEXA globally. The company maintained proprietary production facilities and controlled significant market share until patent expiry.
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Teva Pharmaceutical Industries: A leading generic drug manufacturer, Teva became a major supplier of citalopram hydrobromide API post-patent expiry, leveraging large-scale manufacturing capabilities.
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Mylan Pharmaceuticals: Mylan, now part of Viatris, produced and supplied citalopram hydrobromide API, establishing a widespread supply chain across multiple regions.
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Sandoz (Novartis): Sandoz, Novartis's generics division, produced citalopram API for various markets, providing high-quality standards aligned with regulatory requirements.
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Hetero Labs and Natco Pharma: These Indian generic manufacturers also entered the API space, contributing to competitive pricing and supply security.
Emerging and Regional API Suppliers
Regional manufacturers in China and India have increased their foothold, often supplying the API to regional markets or exporting to global generic manufacturers:
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Heng Feng Pharmaceutical (China): Known for producing a range of antidepressant APIs, including citalopram.
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Jubilant Pharma (India): Engaged in the production of active pharmaceutical ingredients, including selective serotonin reuptake inhibitors.
Manufacturers of Finished Dosage Forms (Tablets)
Post-production of API, pharmaceutical companies formulate CELEXA tablets for the market. These companies may be branded or generic manufacturers, with licensing agreements dictating the supply of finished products.
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Lundbeck: Continues to market CELEXA as a branded product, manufacturing finished doses through its facilities.
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Viatris: As a major generic manufacturer, Viatris produces CELEXA in various formulations and holds market share in numerous countries.
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Actavis (now part of Allergan, acquired by AbbVie): Historically produced generic citalopram formulations, including CELEXA.
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Sun Pharmaceutical Industries: An Indian pharmaceutical giant, producing and distributing generic citalopram tablets.
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Morris Pharmaceutical: Produces generic versions and supplies to various markets globally, including formulations under different brand names.
Distribution and Supply Chain Actors
The distribution of CELEXA involves a network of wholesale distributors, pharmacy chains, and government purchasing agencies, depending on the region.
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Large-scale wholesalers: AmerisourceBergen, McKesson, and Cardinal Health in the United States serve as critical nodes, sourcing finished CELEXA tablets directly from manufacturing entities and distributing to pharmacies and healthcare providers.
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Regional distributors and pharmacies: Various regional suppliers import CELEXA from licensed manufacturers, ensuring accessibility across diverse healthcare systems.
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Authorized Generic Suppliers: Post patent expiry, authorized generics of CELEXA have been supplied by companies such as Teva and Mylan under licensing agreements with the original patent holder or through legal challenges.
Regulatory and Licensing Landscape
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Patent Status: The original patent for CELEXA expired in most markets by the early 2010s, encouraging numerous generics to enter the market.
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Regulatory Approvals: Manufacturers across the globe must seek approval from regulatory bodies such as the FDA (U.S.), EMA (Europe), and others to produce both APIs and finished doses.
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Licensing Agreements: Several manufacturers have licensing arrangements, either as sublicensees or contract manufacturing organizations (CMOs), to produce and distribute CELEXA.
Supply Security and Market Dynamics
The proliferation of generic manufacturers has stabilized CELEXA's supply chain, reducing costs and improving access. However, supply disruptions can sometimes occur due to:
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Raw material shortages: Particularly in the context of geopolitical tensions impacting China and India.
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Manufacturing compliance issues: Regulatory non-compliance can lead to recalls or manufacturing halts.
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Market concentration: While varied, some markets still rely on a limited number of manufacturers, creating potential bottlenecks.
Key Suppliers Summary
| Supplier Type | Major Companies | Region | Notes |
|---|---|---|---|
| API Manufacturers | Lundbeck, Teva, Mylan, Sandoz, Hetero, Natco | Global | Post-patent competition increased supply options |
| Finished Dose Manufacturers | Lundbeck, Viatris, Sun Pharma, Actavis | Global | Branded and generic formulations |
| Distributors | McKesson, AmerisourceBergen, regional distributors | Global | Centralized distribution channels |
Conclusion
The supply chain for CELEXA encompasses a broad spectrum of global manufacturers, with API production primarily concentrated in India, China, and Europe, while finished dosage manufacturing is more globally dispersed. Patent expirations catalyzed market entry by numerous generic producers, leading to increased competition, lower prices, and diversified supply sources. Ensuring supply security remains contingent on raw material availability, regulatory compliance, and geopolitical factors.
Key Takeaways
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The post-patent landscape has diversified CELEXA's supply chain, involving numerous regional and international manufacturers for both API and finished dosage forms.
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Leading API producers include Lundbeck (original) and generic manufacturers like Teva, Mylan, and Sandoz.
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The global market is characterized by competitive pricing, but supply disruptions can occur due to raw material shortages or regulatory issues.
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Stakeholders should maintain close relationships with licensed manufacturers and monitor geopolitical developments affecting supply chains.
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Strategic stockpiling and diversification of sources remain essential to mitigate potential supply shocks.
FAQs
1. Who are the primary API suppliers for CELEXA globally?
Leading API suppliers include Lundbeck (original manufacturer), along with generic firms such as Teva, Mylan, Sandoz, and regional producers in India and China.
2. Has the patent expiry affected the supply chain stability of CELEXA?
Yes. Patent expiry facilitated increased competition from generics, improving supply security and lowering prices, but it also introduced variability in manufacturing quality and regulatory adherence among new entrants.
3. Are there regional differences in the suppliers of CELEXA?
Yes. While North America and Europe predominantly utilize licensed generics from global companies, in India and China, regional manufacturers supply both API and finished doses mainly for local markets or export.
4. How does raw material sourcing impact CELEXA supply security?
Dependence on raw materials from China and India makes the supply vulnerable to geopolitical tensions, trade restrictions, and disruptions in raw material manufacturing.
5. What should healthcare providers consider regarding CELEXA supply?
Providers should verify supplier licensing, adhere to quality standards, consider alternative sources in case of shortages, and monitor regulatory updates affecting manufacturer approvals.
Sources
[1] FDA Drug Approval Reports, 1998.
[2] Lundbeck Annual Reports.
[3] Market analyses from IQVIA and GlobalData, 2022.
[4] WHO Product Information Database, 2021.
[5] European Medicines Agency (EMA).
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