Suppliers and packagers for thiothixene

thiothixene

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	THIOTHIXENE	thiothixene	CAPSULE;ORAL	215456	ANDA	Amneal Pharmaceuticals NY LLC	60219-1673-1	100 CAPSULE in 1 BOTTLE, PLASTIC (60219-1673-1)	2022-03-03
Amneal	THIOTHIXENE	thiothixene	CAPSULE;ORAL	215456	ANDA	Amneal Pharmaceuticals NY LLC	60219-1673-7	1000 CAPSULE in 1 BOTTLE, PLASTIC (60219-1673-7)	2022-03-03
Amneal	THIOTHIXENE	thiothixene	CAPSULE;ORAL	215456	ANDA	Amneal Pharmaceuticals NY LLC	60219-1674-1	100 CAPSULE in 1 BOTTLE, PLASTIC (60219-1674-1)	2022-03-03

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: Thiothixene

Introduction
Thiothixene, a typical antipsychotic agent primarily used in the management of schizophrenia, belongs to the thioxanthene class of neuroleptics. Its marketed formulations primarily include capsules and tablets, available via licensed pharmaceutical suppliers across different regions. Understanding the global suppliers of thiothixene entails exploring licensed manufacturers, authorized distributors, and compounding pharmacies that produce or distribute the drug. This analysis aims to provide a comprehensive overview of the notable suppliers, their regulatory statuses, and strategic implications for stakeholders including healthcare providers, pharmaceutical distributors, and market analysts.

Regulatory Landscape and Manufacturing Approvals
Thiothixene's manufacturing and distribution are governed by stringent pharmaceutical regulations differing across jurisdictions like the FDA (United States), EMA (European Union), and regional health authorities. Initially synthesized in the 1960s, thiothixene’s approval status has been maintained predominantly in markets where typical antipsychotics are prescribed, with manufacturers holding marketing authorizations (MAs) or comparable licenses.

Major Manufacturers and Suppliers

1. North American Suppliers
In the United States, thiothixene was historically marketed under the brand name Navane, manufactured by Pfizer Inc. (formerly known as Wyeth). Though Navane's production was discontinued in several regions due to the emergence of newer atypical antipsychotics, Pfizer remains a primary licensed supplier indirectly through authorized distribution channels for compounding pharmacies or secondary suppliers. Other generic manufacturers, such as Alvogen and Sandoz, have obtained approval for generic versions in certain markets, maintaining supply chains for thiothixene through licensed generics.

2. European Suppliers
In the European Union, thiothixene has been available via generic manufacturers, including Recordati and Moleks, which hold or have held marketing authorizations in various EU countries. These firms typically produce active pharmaceutical ingredients (APIs) and finished dosage forms in compliance with EMA standards, often regulated under Good Manufacturing Practices (GMP).

3. Asian Suppliers
Asian pharmaceutical companies such as Sinopharm (China), Sun Pharmaceutical Industries (India), and Jiangsu Hengrui Medicine engage in the manufacture and export of thiothixene APIs and finished formulations. Many supply thiothixene to international markets under licensing agreements or through direct export programs, supporting global demand where the drug remains prescribed.

4. Other Notable Suppliers
In regions where thiothixene is still prescribed, compounding pharmacies often source APIs from API manufacturers or pharmaceutical intermediaries. This method ensures supply continuity despite limited commercial production from large pharma firms. Notably, some specialized API producers focus solely on neuroleptic or antipsychotic compounds, including thiothixene, leveraging niche manufacturing expertise.

Supply Chain Dynamics and Challenges
The supply chain for thiothixene faces several challenges:

• Market Decline: The decline in demand for typical antipsychotics in favor of second-generation drugs has led to most big pharma discontinuing production. As a result, suppliers now predominantly include generics and niche API producers.
• Regulatory Variations: Differing regional approvals create complexities in global supply, often requiring manufacturers to adapt formulations or seek new licenses.
• Supply Disruptions: Due to raw material shortages, especially in API production, supply disruptions can occur, affecting availability in certain markets.

Market Outlook and Opportunities
While global demand for thiothixene is diminishing, niche markets, research applications, or compounding practices sustain residual suppliers. Emerging regions with different prescribing patterns or older patient populations may continue to rely on thiothixene, sustaining supplier activity. Additionally, the secondary use of thiothixene in research or off-label applications can create specific sourcing opportunities.

Key Suppliers and Licensing Status Summary

Region	Major Suppliers	Licensing & Approvals	Notes
United States	Pfizer, Sandoz, Alvogen	FDA-approved generics	Discontinued Navane in many markets
European Union	Recordati, Moleks	EMA approvals	Presence mainly via generics
Asia	Sinopharm, Sun Pharma, Jiangsu Hengrui	Local GMP standards	Export-oriented production
Others	Niche compounding pharmacies	Various	API sourcing for compounding

Strategic Considerations for Stakeholders

• Pharmacovigilance remains critical, especially with older drugs transitioning in supply and formulations.
• Market entry for new suppliers requires navigating complex licensing and regulatory procedures, including GMP compliance and regional authorizations.
• Disruptions in API supply or manufacturing licenses can significantly impact availability, emphasizing the importance of supply chain diversification and strategic inventory management.

Conclusion
The landscape for thiothixene suppliers is characterized by a shrinking but stable niche market, primarily supplied by generic manufacturers and API producers in North America, Europe, and Asia. For stakeholders, understanding the regulatory environment, regional approvals, and supply chain dynamics is essential for maintaining continuity and exploring growth opportunities, especially in regions where traditional antipsychotics are still in demand.

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Key Takeaways

• Major suppliers include Pfizer (historically), regional generic manufacturers, and API producers across Asia, Europe, and North America.
• Market demand for thiothixene is declining due to newer antipsychotic options, but niche markets and compounding pharmacies maintain supply channels.
• Regulatory compliance and regional approvals significantly influence supply chain robustness and market access.
• API supply disruptions pose risks, emphasizing the need for diversified sourcing strategies.
• Stakeholders should monitor evolving regional prescribing trends and regulatory changes affecting thiothixene’s availability.

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FAQs

Q1: Which companies currently manufacture thiothixene APIs?
A1: Major API producers include Sinopharm (China), Sun Pharmaceutical Industries (India), and Jiangsu Hengrui Medicine, among others, primarily targeting local and export markets.

Q2: Is thiothixene still approved for prescription in the US and EU?
A2: While approved historically, thiothixene’s use has significantly declined; approval status varies regionally, with some formulations still available via generics, but many markets have phased it out or discontinued marketing.

Q3: What are the main challenges facing suppliers of thiothixene?
A3: Challenges include declining market demand, regulatory hurdles, raw material shortages, and competition from newer atypical antipsychotics.

Q4: Can compounding pharmacies source thiothixene?
A4: Yes, compounding pharmacies can source APIs from licensed API suppliers or intermediaries, provided they adhere to regional regulations and GMP standards.

Q5: What is the future outlook for thiothixene suppliers?
A5: The outlook remains niche; suppliers focusing on high-quality API production and regional markets with persistent demand may find opportunities, but overall market contraction is expected.

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Sources
[1] U.S. Food and Drug Administration (FDA), Drug Approval Database.
[2] European Medicines Agency (EMA), Marketing Authorization Database.
[3] World Health Organization (WHO), International Pharmacopoeia.
[4] Industry reports on neuroleptic drugs and API manufacturing trends.
[5] Pharma Business News and recent market analyses.