Bulk Pharmaceutical API Sources for amantadine hydrochloride

Bulk Pharmaceutical API Sources for amantadine hydrochloride

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		Hcn@`HBHPVeV^dUGZjjjh@@
Sigma-Aldrich		A1260_SIGMA
Hangzhou Trylead Chemical Technology		TL8004713
NovoSeek		64150
MP Biomedicals		100187
ISpharm		I14-0454

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

Last updated: July 27, 2025

Introduction

Amantadine hydrochloride is an antiviral and antiparkinsonian agent widely used in managing Parkinson's disease, drug-induced extrapyramidal symptoms, and certain influenza strains. With increasing clinical demand, sourcing high-quality bulk API becomes pivotal for pharmaceutical manufacturers. This report outlines the global landscape of Amantadine Hydrochloride API suppliers, emphasizing their manufacturing capabilities, regulatory compliance, supply stability, and strategic positioning.

Global Manufacturing Landscape of Amantadine Hydrochloride API

Manufacturers in China

China dominates the API production sector for Amantadine Hydrochloride, leveraged by its robust chemical manufacturing infrastructure. Several established producers operate integrated facilities adhering to Good Manufacturing Practices (GMP), ensuring product quality and consistency.

• Zhejiang Hisun Pharmaceutical Co., Ltd.: Recognized for its extensive API portfolio, this company supplies Amantadine Hydrochloride globally. Its facilities are FDA-registered and comply with international standards, offering reliable supply chains for pharmaceutical partners [1].

• Sichuan Friendship Pharmaceutical Group: Known for competitive pricing and high batch consistency, they have catered to multiple markets, including North America and Europe, with GMP-certified production lines [2].

• Jiangsu Huadong Medicine Co.: This firm produces both API and finished dosage forms, with a focus on quality control and regulatory compliance. They have achieved CE and FDA registration status for specific products [3].

Indian API Manufacturers

India retains a significant share of the global API market, including Amantadine Hydrochloride, due to cost advantages and a growing regulatory framework.

• Hetero Labs: With extensive R&D facilities, Hetero supplies APIs globally, emphasizing quality assurance and adherence to stringent regulatory standards.

• Divi's Laboratories: Boasting a diversified API portfolio and strict quality procedures, Divi's supports export markets and has received USFDA approvals for several APIs [4].

• Biological E Limited: A key player with manufacturing capacity for antiviral APIs, actively exporting to North America and Europe.

European and US API Producers

While fewer in number, European and US-based API producers focus on niche, high-value segments, emphasizing regulatory compliance and quality:

• BASF (Germany): Known for high-purity APIs within their pharmaceutical ingredient division, BASF offers Amantadine Hydrochloride with a focus on quality and traceability.

• Cambridge Commodities (UK): Specializes in active ingredients, offering certified API batches suitable for GMP-compliant manufacturing.

• Roxane Laboratories (USA): An established pharmaceutical manufacturer with in-house API sourcing that ensures supply chain security and adherence to US regulations.

Regulatory and Certification Considerations

Manufacturers supplying Amantadine Hydrochloride API must meet multiple regulatory standards:

• FDA Registration and Inspections: Crucial for API suppliers targeting US markets. Ensures compliance with cGMP standards.

• European Pharmacopoeia (EP): Regulatory in Europe; suppliers complying with EP monographs demonstrate rigorous quality controls.

• International Standards: ISO 9001 quality certification, ISO 14001 environmental standards, and certifications addressing chemical safety and worker health.

• Documentation: Certificates of Analysis (CoA), Certificate of Suitability (CEP), and Drug Master Files (DMF) facilitate regulatory acceptance and approvals.

Supply Chain Stability and Market Trends

The demand for Amantadine Hydrochloride fluctuates with viral outbreaks and neurological indications. Demand peaked during influenza seasons and the COVID-19 pandemic, emphasizing the importance of supply reliability.

• Supply Risks: Dependence on Chinese and Indian manufacturing raises concerns over geopolitical tensions, trade restrictions, and supply disruptions (e.g., tariffs, export bans).

• Manufacturing Capacity Expansions: Several producers are investing in expanding capacity and modernization to meet global needs, reducing potential shortages.

• Pricing Dynamics: Price fluctuations correlate with raw material costs, regulatory compliance overhead, and market competition. Cost-effective producers often combine high throughput with strict quality controls.

Strategic Sourcing Recommendations

• Supplier Due Diligence: Verify GMP compliance, regulatory approvals, and quality standards. Prioritize suppliers with established history and global certifications.

• Diversification: Source from multiple regions to mitigate supply chain risks and ensure procurement continuity.

• Regulatory Alignment: Ensure suppliers’ documentation aligns with target markets’ regulations, expediting approval processes.

• Long-term Contracts: Engage in strategic partnerships with reliable suppliers to secure favorable pricing and supply guarantees.

Conclusion

Amantadine Hydrochloride API sourcing is predominantly concentrated in China and India, with a growing subset of suppliers in Europe and North America emphasizing quality and regulatory compliance. Navigating this landscape requires careful evaluation of manufacturing capacity, regulatory credentials, and supply stability. By adopting strategic sourcing methodologies, pharmaceutical companies can ensure consistent production, regulatory compliance, and market competitiveness.

Key Takeaways

• The primary API manufacturing hubs for Amantadine Hydrochloride are China and India, offering cost-effective production with increasing regulatory compliance.

• Suppliers with GMP certification, regulatory approvals (FDA, EP, DMF), and transparent documentation are essential for high-quality sourcing.

• Supply chain risks necessitate diversification and long-term partnerships to ensure uninterrupted API availability.

• Market dynamics are influenced by global health crises, emphasizing the importance of proactive capacity expansion and inventory management.

• Regulatory alignment and comprehensive due diligence streamline approval pathways and safeguard product integrity.

FAQs

1. What are the primary regions manufacturing Amantadine Hydrochloride API?
China and India are the dominant producers, with additional suppliers in Europe and North America focusing on high-quality, regulated supply.

2. How can I verify the quality of API suppliers?
Review GMP certifications, regulatory approvals (e.g., FDA, EMA), Certificates of Analysis (CoA), and conduct audits or third-party assessments when possible.

3. Are Chinese API manufacturers compliant with international quality standards?
Many Chinese suppliers have achieved GMP certification and hold international accreditations, but due diligence is necessary to confirm compliance and product consistency.

4. What supply chain risks exist for Amantadine Hydrochloride API?
Dependence on specific regions, geopolitical tensions, export restrictions, and raw material shortages can disrupt supply stability.

5. How does regulatory compliance impact API sourcing?
Regulatory compliance ensures product quality, facilitates market approval, and mitigates legal and safety risks, making it a critical factor in supplier selection.

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References

[1] Zhejiang Hisun Pharmaceutical Co., Ltd. Official Website. (2023)
[2] Sichuan Friendship Pharmaceutical Group. Annual Report 2022.
[3] Jiangsu Huadong Medicine Co. Regulatory Filings.
[4] Divi's Laboratories Annual Report 2022.