Suppliers and packagers for generic pharmaceutical drug: TIAGABINE HYDROCHLORIDE

TIAGABINE HYDROCHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA, Inc.	0093-5030-56	30 TABLET, FILM COATED in 1 BOTTLE (0093-5030-56)	2016-06-03
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA, Inc.	0093-5031-56	30 TABLET, FILM COATED in 1 BOTTLE (0093-5031-56)	2016-06-03
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA, Inc.	0093-8072-56	30 TABLET, FILM COATED in 1 BOTTLE (0093-8072-56)	2018-03-09

Suppliers for the Pharmaceutical Drug: Tiagabine Hydrochloride

Last updated: August 3, 2025

Introduction

Tiagabine hydrochloride, marketed primarily under the brand name Gabatril, is an antiepileptic medication used to treat partial seizures. As a selective gamma-aminobutyric acid (GABA) reuptake inhibitor, its global manufacturing and supply chain are critical to ensuring uninterrupted availability for patients and healthcare providers. This analysis examines the key suppliers, manufacturing landscape, regulatory considerations, and market dynamics surrounding tiagabine hydrochloride, offering actionable insights for stakeholders in the pharmaceutical supply chain.

Overview of Tiagabine Hydrochloride

Tiagabine hydrochloride was developed by Pfizer and received FDA approval in 1997. Its mechanism involves inhibiting GABA reuptake into neurons and glia, thereby increasing GABA concentration in the synaptic cleft—leading to anticonvulsant effects. Despite being less prevalent compared to other antiepileptics, it remains a vital option for specific patient populations.

Understanding the supply ecosystem is essential given the drug’s market niche, manufacturing complexity, and regulatory landscape.

Key Manufacturers and Suppliers

Original Manufacturers

• Pfizer Inc.
  • Role: Original patent holder and primary manufacturer during the initial approval period.
  • Production: Pfizer's global facilities produced tiagabine hydrochloride under strict Good Manufacturing Practices (GMP). As of the patent expiration in 2013, Pfizer’s role has shifted primarily to generic suppliers.

Generic Manufacturers

Post patent expiry, numerous generic pharmaceutical companies entered the market. The supply chain for tiagabine hydrochloride is now predominantly composed of these generics, which manufacture active pharmaceutical ingredients (APIs) and finished dosage forms.

Leading API Suppliers

1. Hoffmann-La Roche (Switzerland)
   • Known for high-quality APIs, Roche supplies tiagabine hydrochloride to various generic manufacturers.
2. Aurobindo Pharma (India)
   • A significant global API manufacturer, Aurobindo has capacity dedicated to GABA-ergic drugs, including tiagabine hydrochloride.
3. Sun Pharmaceutical Industries (India)
   • Supplies bulk APIs for multiple CNS drugs, including tiagabine hydrochloride, with a focus on cost-effective manufacturing.
4. Hetero Labs (India)
   • Manufactures APIs for CNS medications, including tiagabine hydrochloride, adhering to international standards.
5. Mylan (Part of Viatris)
   • Offers both APIs and finished products, with manufacturing facilities in India and Europe.

Finished Dosage Form Manufacturers

Various generic pharmaceutical companies globally produce tiagabine hydrochloride tablets, including:

• Teva Pharmaceuticals (Israel)
• Sandoz (Novartis)
• Apotex (Canada)
• Lupin Pharmaceuticals (India)
• Dr. Reddy’s Laboratories (India)

Their manufacturing capacities are distributed across North America, Europe, and Asia, aligning with regional market demands.

Supply Chain Dynamics

The supply chain involves multiple tiers:

• API Production: Raw material procurement, synthesis, and quality control.
• Formulation: Conversion of APIs into tablet forms, involving excipient sourcing and formulation optimization.
• Packaging & Distribution: Ensuring stability and compliance for global distribution.

The decentralization of API manufacturing, primarily in India and China, amplifies the importance of supply chain resilience.

Regulatory Considerations Impacting Suppliers

The active ingredient’s manufacturing sites must comply with stringent regulatory standards, including FDA cGMP, EMA guidelines, and WHO certifications. Regulatory audits, potential manufacturing site inspections, and batch release approvals influence supplier reliability.

During recent years, tightening regulations around quality standards and increased scrutiny of Chinese and Indian suppliers have caused shifts in the supply landscape. Suppliers who have achieved strict compliance often regain market confidence and secure long-term supply contracts.

Market Trends and Supply Challenges

Market Demand and Supply Stability

Although tiagabine hydrochloride holds a niche role, steady demand persists in epilepsy treatment. Supply stability hinges on continuous manufacturing, regulatory compliance, and geopolitical stability in manufacturing regions.

Intellectual Property and Patent Landscape

The patent expiration in 2013 allowed for multiple generics to enter the market, increasing options but also fragmenting supply and potentially leading to variations in manufacturing quality. Suppliers’ reputation, regulatory approval, and adherence to quality standards are determinants of market access.

Raw Material and Global Disruption Factors

Global supply disruptions, exemplified by COVID-19, have impacted raw material procurement, leading to shortages or delays. Suppliers with diversified supply chains and international manufacturing footprints are better positioned to mitigate such risks.

Emerging Trends

• Scale-up and Contract Manufacturing: Larger generic firms are expanding capacities via partnerships with Contract Manufacturing Organizations (CMOs).
• Quality Assurance Enhancements: Increasingly rigorous quality standards incentivize suppliers to invest in advanced quality management.
• Regional Market Focus: Growth in emerging markets, especially Asia and Latin America, intensifies regional supplier competition.

Strategic Implications for Stakeholders

• Healthcare providers should assess supplier reliability based on regulatory compliance and manufacturing capacity.
• Pharmaceutical companies sourcing tiagabine hydrochloride should prioritize suppliers with proven quality records and regulatory approvals.
• Investors should monitor regulatory and geopolitical developments affecting key supplier regions.

Conclusion

The supply ecosystem for tiagabine hydrochloride now predominantly comprises high-quality Indian and global generic manufacturers, with key API suppliers including Hoffmann-La Roche, Aurobindo Pharma, Sun Pharma, and Hetero Labs. Market stability depends on rigorous regulatory oversight, regional manufacturing capabilities, and resilient supply chains amid ongoing geopolitical and logistic challenges.

Ensuring a consistent supply requires ongoing assessments of supplier compliance, capacity expansion, and market dynamics — critical aspects for stakeholders involved in procurement, manufacturing, and market strategy.

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Key Takeaways

• Post-patent expiry, tiagabine hydrochloride's supply chain is dominated by Indian and global generic manufacturers.
• API suppliers like Aurobindo Pharma, Sun Pharma, Hetero Labs, and Roche are critical to global availability.
• Regulatory compliance and quality assurance are central to supplier reliability amid tightening international standards.
• Supply chain resilience is threatened by raw material disruptions and geopolitical factors, emphasizing diversification strategies.
• Continuous monitoring of market trends, regulatory landscapes, and new manufacturing capacities can inform strategic procurement decisions.

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FAQs

1. Who are the primary API suppliers for tiagabine hydrochloride?
The leading API suppliers include Hoffmann-La Roche, Aurobindo Pharma, Sun Pharmaceutical Industries, and Hetero Labs, primarily based in India and Switzerland, trusted for their manufacturing quality and regulatory compliance [1].

2. Are there any patent restrictions affecting the supply of tiagabine hydrochloride?
The original patent held by Pfizer expired in 2013, opening the market to generic manufacturing. Current supply relies on multiple generics, with no active patent restrictions hindering production [2].

3. What regions dominate the manufacturing of tiagabine hydrochloride APIs?
India and China are the primary regions due to cost advantages and established pharmaceutical manufacturing infrastructure. European companies like Roche contribute high-quality APIs for select markets [3].

4. How does regulatory compliance impact tiagabine hydrochloride supply?
Regulatory compliance ensures quality standards necessary for market approval. Suppliers with GMP certification and successful audits are favored, reducing the risk of supply disruptions [4].

5. What are future considerations for stakeholders sourcing tiagabine hydrochloride?
Stakeholders should focus on supplier compliance, capacity expansion, raw material sourcing diversification, and geopolitical risks to ensure a stable and compliant supply chain.

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Sources

1. [1] U.S. Food & Drug Administration. "Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)."
2. [2] PatentScope. WIPO. "Patent Expiry and Generic Entry."
3. [3] IMS Health. "Global API Manufacturing Rankings."
4. [4] European Medicines Agency. "Regulatory Guidelines for Active Pharmaceutical Ingredient Manufacturing."