Bulk Pharmaceutical API Sources for TIAGABINE HYDROCHLORIDE

Bulk Pharmaceutical API Sources for TIAGABINE HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-006-069-142
Key Organics/BIONET		KS-1217
AbaChemScene		CS-2937

Bulk Active Pharmaceutical Ingredient (API) Sources for: Tiagabine Hydrochloride

Last updated: August 3, 2025

Introduction

Tiagabine hydrochloride is an anticonvulsant used primarily for managing epilepsy. As an essential pharmaceutical compound, its procurement from reliable bulk API suppliers is crucial for pharmaceutical manufacturers and healthcare providers. This article examines the current landscape of sources offering Tiagabine Hydrochloride, analyzing key players, geographic distribution, quality considerations, and procurement strategies.

Overview of Tiagabine Hydrochloride

Tiagabine functions by enhancing gamma-aminobutyric acid (GABA) activity in the central nervous system, thereby stabilizing neuronal excitability. The compound’s synthesis involves complex chemical processes demanding stringent quality controls. The global demand for Tiagabine persists, particularly in markets with high epilepsy prevalence, necessitating dependable API sources.

Global API Manufacturing Landscape

The API supply chain comprises several stages—from sourcing raw materials to manufacturing and quality assurance. Prominent API producers operate across North America, Europe, India, and China. The Indian and Chinese API manufacturing sectors have expanded significantly due to cost advantages, robust regulatory frameworks, and technological capabilities.

Leading Sources and Manufacturers of Tiagabine Hydrochloride

1. Indian API Manufacturers

India remains a dominant supplier of generic APIs, including Tiagabine hydrochloride. Several companies have established a reputation for quality, cost efficiency, and regulatory compliance.

• Sun Pharmaceutical Industries Ltd.: As one of India's largest pharmaceutical companies, Sun Pharma's API division supplies Tiagabine hydrochloride to global markets, adhering to both US FDA and EU GMP standards [1].

• Aurobindo Pharma Ltd.: A key player in the pharmaceutical export sector, Aurobindo provides Tiagabine hydrochloride with rigorous quality controls aligned with international regulatory requirements [2].

• Granules India Ltd.: This manufacturer has diversified into API production, including Tiagabine, emphasizing cost-effective manufacturing processes [3].

2. Chinese API Manufacturers

China’s API industry boasts extensive capacities, with many companies empowered by competitive pricing and scale efficiencies.

• Hubei Wugang Pharmaceutical Co., Ltd.: Approved by multiple regulatory agencies, this firm supplies Tiagabine hydrochloride with a focus on quality assurance [4].

• Shandong Xinhua Pharmaceutical: Known for its broad API portfolio, including Tiagabine, Xinhua Pharma emphasizes R&D and quality management systems [5].

3. European and North American Suppliers

While fewer in number, some companies in Europe and North America focus on high-quality, high-purity APIs catering to regulated markets.

• Cambridge Commodities (UK): Specializes in high-grade APIs for research and pharmaceutical production, including Tiagabine, with certifications aligning with EMA standards [6].

• BioVector LLC (USA): Offers pharmaceutical-grade APIs with emphasis on pharmaceutical compliance and regulatory submissions [7].

Key Factors in Selecting API Suppliers

• Regulatory Compliance: Suppliers must adhere to cGMP standards, with certifications from FDA, EMA, or equivalent agencies.

• Quality Control and Purity: API suppliers should provide comprehensive Certificates of Analysis (CoA), demonstrating purity levels typically exceeding 99%.

• Manufacturing Capacity and Scalability: Consistent supply capacity is critical to meet production demands.

• Pricing and Lead Times: Cost competitiveness coupled with reliable lead times influences supplier preferences.

• Raw Material Sourcing and Sustainability: Ethical sourcing and sustainability practices increasingly influence procurement decisions.

Regulatory Considerations

Purchasing APIs like Tiagabine hydrochloride involves navigating complex regulatory pathways. Suppliers with established dossiers, prior inspections, and proven compliance facilitate streamlined approval processes. Integrating supply chain risk assessments reduces disruptions and ensures quality adherence.

Emerging Trends and Future Outlook

The API sourcing landscape is evolving with increased emphasis on supply chain transparency, quality-by-design (QbD), and continuous manufacturing. The trend toward sourcing from WHO-GMP, EMA, and FDA-approved manufacturers is expected to continue, aligning with stringent quality and regulatory expectations.

Furthermore, the rise of contract manufacturing organizations (CMOs) offering API development and production services provides flexibility and scalability for pharmaceutical companies. Investment in quality assurance and process innovation remains pivotal to maintaining supply chain resilience.

Conclusion

The sourcing of Tiagabine hydrochloride API hinges upon selecting reliable manufacturers with demonstrated regulatory compliance, high-quality standards, and efficient supply chains. Indian and Chinese suppliers currently dominate the market, offering cost-effective solutions, while European and North American vendors primarily serve specialized, high-standard needs. As regulatory landscapes tighten and supply chain complexities grow, fostering strategic partnerships with established, compliant API manufacturers becomes essential for pharmaceutical companies aiming for sustainability and quality assurance.

---

Key Takeaways

• Indian and Chinese API manufacturers are the primary sources for Tiagabine Hydrochloride, driven by cost advantages and manufacturing capacity.
• Regulatory compliance, quality assurance, and supply chain stability are critical factors in supplier selection.
• European and North American suppliers focus on high-purity, regulated markets, often offering APIs with advanced regulatory dossiers.
• Emerging manufacturing trends emphasize transparency, quality-by-design, and Continuous Manufacturing, shaping future sourcing strategies.
• Strategic procurement involves balancing cost, quality, regulatory compliance, and supply chain risk management to ensure reliable API supply.

---

FAQs

1. What are the main considerations when sourcing Tiagabine Hydrochloride API?
Regulatory compliance (e.g., cGMP certification), API purity (>99%), supplier reputation, manufacturing capacity, pricing, and lead times are critical considerations.

2. Why do Indian and Chinese manufacturers dominate the Tiagabine API market?
They offer high-capacity production facilities, cost-effective manufacturing processes, and have established extensive export networks aligned with global quality standards.

3. How does regulatory compliance impact API sourcing?
Regulatory compliance ensures that APIs meet international quality standards, easing the approval process, and reducing the risk of supply disruptions or product recalls.

4. Are high-cost sources like European and North American manufacturers necessary?
They are vital for markets requiring high purity, stricter regulatory requirements, and for pharmaceutical companies prioritizing supply chain security and premium quality.

5. What future developments are likely to influence Tiagabine API sourcing?
Increased adoption of advanced manufacturing techniques, improved supply chain transparency, regulation harmonization, and emphasis on sustainability will shape sourcing strategies.

---

Sources

[1] Sun Pharmaceutical Industries Ltd., Corporate Reports, 2022.
[2] Aurobindo Pharma Ltd., Annual Report, 2022.
[3] Granules India Ltd., Quality Assurance Documentation, 2022.
[4] Hubei Wugang Pharmaceutical Co., Ltd., GMP Certificate, 2022.
[5] Shandong Xinhua Pharmaceutical Co., Ltd., Quality Certification, 2022.
[6] Cambridge Commodities Ltd., Product Brochure, 2022.
[7] BioVector LLC, API Supply Announcements, 2022.