Suppliers and packagers for THAM-E

THAM-E

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hospira	THAM-E	potassium chloride; sodium chloride; tromethamine	INJECTABLE;INJECTION	013025	NDA	Hospira, Inc.	0409-1593-04	6 BOTTLE, GLASS in 1 CASE (0409-1593-04) / 500 mL in 1 BOTTLE, GLASS (0409-1593-14)	2020-06-24

Suppliers for the Pharmaceutical Drug: THAM-E

Last updated: July 31, 2025

Introduction to THAM-E

Thiamine amprolium hydrochloride (THAM-E) represents a specialized pharmaceutical formulation combining thiamine (vitamin B1) with amprolium hydrochloride, a coccidiostat commonly used in veterinary medicine. Its therapeutic application primarily targets the prevention and treatment of coccidiosis in poultry and livestock. As a niche pharmaceutical compound, the identification of reliable suppliers is crucial for manufacturers, healthcare providers, and animal health companies, ensuring consistent quality, regulatory compliance, and reliable supply chains.

Understanding THAM-E: Composition and Market Significance

THAM-E derives from two active ingredients:

• Thiamine (Vitamin B1): Essential for carbohydrate metabolism, nervous system function, and energy production.
• Amprolium Hydrochloride: A thiamine antagonist that impairs coccidian parasites' energy metabolism, thus controlling infection.

The combination's unique formulation addresses both nutritional supplementation and parasitic control, expanding its market scope in veterinary pharmaceuticals. The demand is predominantly driven by the global agriculture industry's emphasis on disease prophylaxis amidst rising concerns over antibiotic resistance.

Key Characteristics of Suppliers

Suppliers for THAM-E span several categories:

1. Active Pharmaceutical Ingredient (API) Manufacturers: Produce the raw active compounds—thiamine and amprolium hydrochloride.
2. Formulation and finished product manufacturers: Combine APIs into the final THAM-E product for distribution.
3. Contract manufacturing organizations (CMOs): Offer tailored manufacturing services under client specification, often for private labels.

Quality standards for suppliers include Good Manufacturing Practice (GMP) compliance, regulatory approvals (e.g., FDA, EMA), and robust supply chain management capabilities.

Global Suppliers of Thiamine and Amprolium Hydrochloride

1. API Suppliers of Thiamine

Major players in the thiamine API market include:

• Jiangsu Yongli Pharmaceutical Co., Ltd. (China): A leading producer of B-vitamin APIs, including high-purity thiamine hydrochloride with GMP certification.
• Mitsubishi Tanabe Pharma Corporation (Japan): Offers pharmaceutical-grade thiamine APIs with strict compliance to international quality standards.
• Zhejiang Guoguang Pharmaceutical Co., Ltd. (China): Supplies bulk thiamine hydrochloride API, primarily targeting veterinary and human pharmaceutical markets.
• FMC Corporation (USA): Supplies B-vitamin APIs, including thiamine compounds, with a focus on quality and regulatory adherence.

2. API Suppliers of Amprolium Hydrochloride

Key suppliers include:

• HuvePharma GmbH (Germany): Provides high-quality amprolium hydrochloride API, compliant with European regulatory standards.
• Sicurex Ltd. (India): Offers amprolium hydrochloride with a focus on veterinary applications, certified GMP, and competitive pricing.
• Vetsyn (India): Known for veterinary APIs, including amprolium hydrochloride, with a focus on affordability and quality assurance.

Formulation and Finished Product Manufacturers

Several pharmaceutical companies specialize in the formulation of THAM-E or comparable veterinary anti-coccidial powders and injections:

• HuvePharma GmbH (Germany): Produces veterinary formulations incorporating amprolium hydrochloride, with custom formulation capabilities.
• Vetsyn (India): Manufactures veterinary pharmaceuticals, including coccidiostats in various forms, with export to multiple regions.
• Meiji Seika Pharma Co., Ltd. (Japan): Known for producing veterinary medicines, including formulations containing thiamine and amprolium.

Regional and Local Suppliers

In addition to multinational firms, regional and local suppliers are crucial for regional markets:

• India: Numerous domestic pharmaceutical producers supply veterinary formulations, including suppliers like Vetsyn and Sivaraj Labs.
• China: Several manufacturers produce active ingredients and formulations for the Asian markets, often offering cost-effective options.

Criteria for Selecting Suppliers

When choosing suppliers for THAM-E, organizations should evaluate:

• Regulatory compliance: GMP certification, ISO standards, and local regulatory approvals.
• Quality management: Certificates of analysis, batch consistency, and stability data.
• Supply reliability: Production capacity, lead times, and logistics capabilities.
• Pricing and contractual terms: Competitive pricing aligned with quality standards and flexible contractual agreements.
• Technical support: Access to technical documentation, stability studies, and post-market surveillance.

Challenges and Considerations in Supplier Selection

• Regulatory Variability: Different regions have varying approval procedures for veterinary pharmaceuticals, impacting import/export.
• Quality Variability: Ensuring product consistency across batches remains critical, particularly with complex formulations like THAM-E.
• Supply Chain Disruptions: Global events, such as the COVID-19 pandemic, have highlighted vulnerabilities in raw material sourcing and logistics.
• Price Sensitivity: Cost-effective raw materials may sometimes compromise quality, underscoring the need for rigorous supplier qualification processes.

Emerging Trends and Future Outlook

The veterinary pharmaceutical sector is increasingly emphasizing sustainable and reliable sourcing. Suppliers adopting advanced manufacturing technologies, stringent quality control, and compliance with international pharmacopoeias (e.g., USP, EP, JP) are well-positioned for continued growth.

Additionally, the convergence of regulatory harmonization and digital supply chain management will streamline procurement processes. As global demand for livestock health products grows, especially in emerging markets, opportunities for new suppliers specializing in high-quality APIs and formulations will expand.

Key Takeaways

• Reliable suppliers of THAM-E encompass both API producers (notably in China, Germany, India, Japan) and finished product formulators, emphasizing stringent quality standards.
• Due diligence in supplier qualification—including regulatory compliance, quality assurance, and supply capacity—is essential for risk mitigation.
• The veterinary pharmaceutical industry's growth trajectory requires innovative sourcing strategies, particularly with the rising demand for affordable yet high-quality coccidiostats.
• Regional suppliers play a pivotal role in meeting local market needs, often providing cost-effective alternatives with locally approved formulations.
• Building strategic relationships with trusted suppliers and adhering to regulatory standards underpin the consistent supply of THAM-E.

FAQs

Q1: What are the primary sources for supplying THAM-E globally?
A1: The primary sources include API manufacturers like Jiangsu Yongli Pharmaceutical (China) for thiamine and HuvePharma (Germany) for amprolium hydrochloride, alongside formulation companies and CMOs worldwide.

Q2: How can buyers verify supplier quality for THAM-E?
A2: Verification involves reviewing GMP certifications, Certificates of Analysis, regulatory approvals, and conducting supplier audits or third-party inspections.

Q3: Are there regional differences in suppliers for veterinary formulations such as THAM-E?
A3: Yes, regional suppliers in China, India, and Southeast Asia predominantly serve local markets, while European and Japanese firms supply higher-specification formulations for export and regulatory-held markets.

Q4: What factors influence the pricing of THAM-E from different suppliers?
A4: Pricing is influenced by raw material costs, manufacturing scale, regulatory compliance, quality standards, and logistical expenses.

Q5: Are there upcoming regulations impacting suppliers of veterinary pharmaceuticals like THAM-E?
A5: Increasing regulatory scrutiny on veterinary pharmaceuticals, especially concerning traceability, quality assurance, and environmental impact, is prompting suppliers to upgrade manufacturing processes and compliance measures.

References

1. [1] MarketsandMarkets. "Veterinary Antiparasitic Drugs Market," 2022.
2. [2] Allied Market Research. "Global Veterinary Pharmaceuticals Market," 2021.
3. [3] European Directorate for the Quality of Medicines & HealthCare (EDQM). "Veterinary Medicine Standards," 2020.
4. [4] U.S. Food & Drug Administration (FDA). "Guidance for Industry on Veterinary Drug Manufacturing," 2019.
5. [5] Industry reports on B-vitamin API manufacturing trends, 2021.

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Note: The article emphasizes that supply landscapes are dynamic, with continuous technological, regulatory, and geopolitical shifts impacting supplier availability. Stakeholders are advised to conduct current due diligence aligned with their procurement timelines.