Suppliers and packagers for generic pharmaceutical drug: VORTIOXETINE HYDROBROMIDE

VORTIOXETINE HYDROBROMIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447	NDA	Cardinal Health 107, LLC	55154-0256-8	2520 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0256-8)	2013-10-02
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447	NDA	Cardinal Health 107, LLC	55154-0257-8	2430 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0257-8)	2013-10-02
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447	NDA	Takeda Pharmaceuticals America, Inc.	64764-720-07	1 BOTTLE in 1 CARTON (64764-720-07) / 7 TABLET, FILM COATED in 1 BOTTLE	2013-10-02
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447	NDA	Takeda Pharmaceuticals America, Inc.	64764-720-09	30 TABLET, FILM COATED in 1 BOTTLE (64764-720-09)	2013-10-02

Suppliers for the Pharmaceutical Drug: Vortioxetine Hydrobromide

Last updated: July 30, 2025

Introduction

Vortioxetine hydrobromide is a novel antidepressant approved for the treatment of major depressive disorder (MDD) in adults. It operates as a serotonergic agent with multimodal activity, including serotonin reuptake inhibition and modulation of various serotonin receptors. As an essential psychotropic medication, vortioxetine's supply chain is critical for global healthcare providers, pharmaceutical companies, and patients. Securing reliable supplier channels, understanding manufacturing landscape, and identifying authorized distributors are vital for stakeholders aiming to ensure drug availability, quality, and compliance.

Manufacturers and Patent Holders

The primary manufacturer of vortioxetine hydrobromide is Lundbeck, a Danish pharmaceutical company that developed and holds the patent rights for the drug. Lundbeck introduced vortioxetine under brand names like Trintellix (in the USA) and Brintellix (in some markets). The company's global manufacturing facilities produce the active pharmaceutical ingredient (API) and finished dosage forms, ensuring quality control and adherence to regulatory standards.

In addition to Lundbeck, several Contract Manufacturing Organizations (CMOs) operate within the supply chain, producing vortioxetine hydrobromide under licensing agreements or as authorized suppliers for generic manufacturers. These CMOs often operate in regions with established pharmaceutical manufacturing infrastructure, including India, China, and Europe.

Global API Suppliers

The API (Active Pharmaceutical Ingredient) for vortioxetine hydrobromide is complex to synthesize, requiring advanced chemical processes to ensure purity and stability. Several API manufacturers globally supply vortioxetine hydrobromide, primarily in the following regions:

India

India boasts a robust pharmaceutical manufacturing sector with several API producers capable of supplying vortioxetine hydrobromide, either through licensed production or as generic API manufacturers. Companies like Shilpa Medicare, Natco Pharma, and Hetero Drugs are known for producing APIs for antidepressants and may have capacities for vortioxetine hydrobromide, contingent upon licensing agreements.

China

Chinese pharmaceutical API producers are significant players in the generics market, including antidepressants. Manufacturers such as Hubei Huishen Pharmaceutical Co. and Qingdao Yiqing Pharmaceutical Co. are known for producing serotonergic and CNS-targeted APIs, possibly including vortioxetine hydrobromide, often under licensing or contractual agreements.

Europe and North America

European and North American API suppliers tend to operate within high regulatory frameworks, ensuring product quality and compliance with EMA or FDA standards. Companies like Fresenius Kabi or Boehringer Ingelheim may produce vortioxetine hydrobromide APIs for their markets or for export, often under strict licensing arrangements.

Generic API Manufacturers

In the current pharmaceutical landscape, many generics manufacturers have entered the vortioxetine hydrobromide market following patent expiration or through licensing agreements. The market is characterized by a mixture of regional suppliers meeting local demand and multinational API producers capable of supplying worldwide.

Finished Dosage Form Suppliers

The finished tablets of vortioxetine hydrobromide are supplied by licensed pharmaceutical companies across multiple markets:

• Lundbeck: As the innovator, Lundbeck remains the primary provider of branded vortioxetine formulations globally.
• Generics manufacturers: Once patent rights expire, multiple generic companies launch their formulations, such as Teva Pharmaceuticals, Mylan, and Sun Pharmaceutical Industries, producing vortioxetine tablets for various markets.
• Local pharmaceutical companies: In emerging markets, regional pharmaceutical companies manufacture and distribute vortioxetine hydrobromide under local regulatory approvals, often relying on imported APIs.

Regulatory and Quality Considerations

Suppliers must adhere to Good Manufacturing Practices (GMP) established by bodies like the FDA, EMA, and WHO. The quality of vortioxetine hydrobromide—particularly purity, potency, and stability—is critical to prevent adverse effects and ensure therapeutic efficacy.

Pharmaceutical companies often vet suppliers through qualification audits, requiring Certificates of Analysis (CoA), batch records, and GMP compliance documentation. Regulatory agencies conduct inspections and verify manufacturing practices before approving suppliers for pharmaceutical use.

Supply Chain Challenges

• Patent Expiry and Generic Entrants: As patents expire, numerous generics suppliers enter the market, increasing competition but challenging supply chain stability.
• Manufacturing Complexity: The synthesis of vortioxetine hydrobromide involves advanced chemistry, limiting the number of qualified producers.
• Regional Regulatory Barriers: Variations in regulatory requirements across countries can impact supplier selection and product registration.
• Supply Disruptions: Political, economic, or pandemic-related disruptions can impact API and finished product availability.

Emerging Trends and Future Outlook

The global demand for vortioxetine hydrobromide is projected to grow, driven by increasing awareness of depression management and expanding indications. This growth incentivizes current suppliers to scale manufacturing and new entrants to enter the market, especially in regions with unmet therapeutic needs.

Advances in synthesis technology and regulatory harmonization are expected to improve supply chain resilience. Moreover, manufacturers are emphasizing digitalization and supply chain transparency, reducing risks associated with counterfeit or substandard products.

Key Takeaways

• Leading Manufacturers: Lundbeck remains the primary producer of vortioxetine hydrobromide, with numerous licensed API and formulation manufacturers globally.
• Global Supply Sources: API suppliers are active in India, China, Europe, and North America, with a growing presence of generics following patent expirations.
• Regulatory Oversight: Strict GMP compliance is essential for quality assurance, with suppliers vetted through rigorous regulatory processes.
• Market Dynamics: Increasing demand, patent expiries, and regional manufacturing capabilities shape the supply landscape.
• Supply Chain Risks: Complex synthesis, regional regulations, and geopolitical factors require strategic sourcing and diversification.

FAQs

1. Who are the primary producers of vortioxetine hydrobromide API?

Lundbeck develops and supplies the original API, while multiple licensed manufacturers in India, China, and Europe produce vortioxetine hydrobromide for generics and export markets—often under licensing agreements or as contracted suppliers.

2. Are there alternative suppliers for vortioxetine hydrobromide for pharmaceutical companies?

Yes. Following patent expiration, various generic API producers and CMOs have entered the market, providing alternative sources for formulators seeking supply chain flexibility.

3. What quality standards should suppliers of vortioxetine hydrobromide meet?

Suppliers must comply with GMP standards established by authorities like the FDA, EMA, or WHO. Certificates of Analysis, batch validation data, and GMP compliance documentation are integral to supplier qualification.

4. How might geopolitical factors impact vortioxetine hydrobromide supply?

Regional regulations, trade restrictions, or geopolitical tensions can disrupt supply chains, especially in key manufacturing hubs like China and India. Diversification and supply chain resilience strategies are essential to mitigate risks.

5. What is the outlook for vortioxetine hydrobromide suppliers in the coming years?

Demand is expected to rise due to increasing global awareness and approval of vortioxetine for depression. Manufacturers investing in scaling production, improving synthesis technologies, and ensuring regulatory compliance will shape the future supply landscape.

Sources

1. Lundbeck, Official Website. "Vortioxetine (Trintellix) Product Details." https://www.lundbeck.com
2. US FDA. "Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)." 2022.
3. World Health Organization. “WHO Good Manufacturing Practices (GMP) Guidelines.” 2021.
4. Market Research Reports. “Global Antidepressant Market Analysis,” IQVIA, 2022.
5. Industry News. “Emerging API Suppliers in CNS Therapeutics,” PharmaTech, 2022.

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This comprehensive overview aims to equip pharmaceutical professionals, investors, and healthcare stakeholders with vital insights regarding vortioxetine hydrobromide’s supply sources, manufacturing landscape, and future prospects. For strategic procurement, rigorous supplier assessment, and mitigation of supply chain risks, maintaining awareness of the evolving supplier environment is crucial.