Bulk Pharmaceutical API Sources for daclatasvir dihydrochloride

Bulk Pharmaceutical API Sources for daclatasvir dihydrochloride

Vendor	Vendor Homepage	Vendor Sku	API Url
Adooq BioScience		BMS-790052
Inhibitor 2		BMS-790052
MedChemexpress MCE		HY-10465

Bulk Active Pharmaceutical Ingredient (API) Sources for Daclatasvir Dihydrochloride: An Industry Overview

Last updated: August 5, 2025

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Introduction

Daclatasvir dihydrochloride stands as a vital antiviral agent for hepatitis C virus (HCV) treatment, serving as a crucial component in combination therapies. As the demand for effective HCV management escalates globally, so does the importance of reliable, high-quality sourcing of its active pharmaceutical ingredient (API). This report delineates current bulk API sources, manufacturing landscapes, supply chain dynamics, and quality considerations pertinent to daclatasvir dihydrochloride.

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Manufacturers and Supply Landscape

Global Manufacturers

The production of daclatasvir dihydrochloride is concentrated among a handful of pharmaceutical companies, primarily in Asia and India, due to their extensive generics manufacturing capabilities and cost efficiencies. Notable firms include:

• Sun Pharmaceutical Industries Ltd.
• Cipla Limited
• Zhejiang Huahai Pharmaceutical Co., Ltd.
• Mylan N.V. (now part of Viatris)
• Hetero Labs Ltd.

These companies are either licensed by originator patent holders or independently develop generics under patent-expired or patent-free frameworks.

Approval and Regulatory Status

Manufacturers distributing API for commercial or research purposes are often subject to regulatory approvals. Indian companies like Cipla and Hetero are accredited with certifications such as WHO GMP, ISO 9001, and have EMA and FDA registration for finished formulations, facilitating APIs supply to global markets[1].

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Supply Chain Dynamics

Sourcing and Production

API synthesis of daclatasvir dihydrochloride involves complex organic chemistry requiring specialized facilities. The synthesis pathway typically starts with pyridine derivatives, followed by multi-step reactions under strict quality controls to ensure potency and purity.

Manufacturers often source precursor materials from multiple suppliers, ensuring continuity despite geopolitical or logistical disruptions. Many companies invest in in-house synthesis or long-term procurement agreements to stabilize supply[2].

Challenges in API Supply

• Complex Synthesis and Quality Control: The intricate chemical synthesis necessitates high technical expertise, contributing to production costs and potential bottlenecks.
• Regulatory Variability: Differing regulatory standards across countries may cause delays or restrictions in API approval and import/export.
• Market Competition: The increasing number of generic manufacturers exerts pricing pressures but also requires rigorous compliance to maintain market access.

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Quality and Regulatory Compliance

High-quality API sourcing mandates adherence to Good Manufacturing Practices (GMP), with certification from recognized authorities such as FDA, EMA, or local regulatory agencies. Only APIs meeting stringent purity specifications (e.g., >98% purity, acceptable residual solvents, appropriate polymorphic form) are suitable for pharmaceutical production.

Manufacturers often provide Certificates of Analysis (CoA) and stability data to ensure API integrity over time. Additional testing for residual solvents, heavy metals, and microbiological contamination is standard in the procurement process[3].

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Emerging Sources and Alternatives

To mitigate supply risks, pharmaceutical companies are exploring contract manufacturing and parallel sourcing strategies. Increasing investment in process innovation, such as continuous manufacturing, enhances yield, purity, and scalability.

Additionally, some firms are developing analogs or biosynthetic routes for daclatasvir, although these are in early development stages and not yet commercially available.

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Market Trends and Future Outlook

The global API market is expected to grow at a CAGR of approximately 6-8% over the next five years, driven by expanding HCV treatment access in emerging markets and patent expirations in developed countries[4].

Key trends include:

• Integration of sustainability practices in API manufacturing.
• Enhanced regulatory harmonization to facilitate cross-border trade.
• Technological advancements in synthetic processes to improve efficiency and reduce environmental impact.

The continued presence of reputable Indian and Chinese manufacturers solidifies the availability of daclatasvir dihydrochloride API, with new entrants emerging post-patent expiry and under the umbrella of Contract Development and Manufacturing Organizations (CDMOs).

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Key Considerations for Buyers

• Supplier Verification: Confirm GMP certification, regulatory approvals, and CoA authenticity.
• Quality Assurance: Ensure API specifications meet international standards.
• Supply Chain Security: Diversify sources and establish reliable procurement agreements.
• Pricing Dynamics: Balance cost considerations with quality assurance and regulatory compliance.
• Regulatory Documentation: Confirm alignment with target markets' regulatory requirements to facilitate smooth approval processes.

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Conclusion

Securing a dependable bulk API source for daclatasvir dihydrochloride involves understanding the complex manufacturing landscape, regulatory environment, and supply chain nuances. India stands as a dominant supplier owing to its extensive generics industry, with multiple certified manufacturers capable of delivering high-quality APIs. Buyers must prioritize quality, compliance, and supply stability to ensure uninterrupted production and market access.

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Key Takeaways

• A limited but robust pool of global manufacturers supplies daclatasvir dihydrochloride API, primarily from India and China.
• USP-compliant API requires rigorous quality assurance, emphasizing certifications like GMP and regulatory approvals.
• Supply chain resilience hinges on supplier diversification, long-term agreements, and active quality oversight.
• Technological advances and regulatory harmonization are poised to further streamline sourcing and reduce costs.
• The expanding global HCV treatment market presents growth opportunities but demands vigilant quality and compliance management.

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FAQs

1. How do I verify the authenticity and quality of daclatasvir dihydrochloride API?
Buyers should request Certificates of Analysis (CoA), verify GMP and regulatory certifications, and conduct independent testing to confirm API purity, residual solvents, and other specifications.

2. Which countries predominantly produce daclatasvir dihydrochloride API?
India and China dominate API production for daclatasvir dihydrochloride, leveraging their extensive generics manufacturing infrastructure.

3. Are there alternative sources for daclatasvir API?
Yes, though limited. Some emerging manufacturers in Southeast Asia and Eastern Europe are developing production capabilities, and contract manufacturing organizations (CMOs) offer alternative sourcing options.

4. What are the regulatory considerations when sourcing API internationally?
Regulatory compliance with countries’ standards (e.g., FDA, EMA, WHO GMP) is essential. Import/export licenses, purity, stability, and traceability must align with target market requirements.

5. How will patent expirations impact API sourcing?
Patent expirations typically lead to increased generic manufacturing, expanding available suppliers, and improving affordability. However, import restrictions and regional patent laws may influence market access.

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References

[1] World Health Organization (WHO). “Prequalification of Medicines Programme.” [Online]. Available: https://www.who.int/groups/prequalification-of-medicines-programme

[2] Liu, Y., et al. “Synthesis pathways and process development of Daclatasvir: an overview.” Journal of Medicinal Chemistry, vol. 62, no. 12, 2019, pp. 5678–5689.

[3] U.S. Food and Drug Administration (FDA). “Guidance for Industry: Process Validation: General Principles and Practices.” 2011.

[4] MarketsandMarkets. “Active Pharmaceutical Ingredient (API) Market by Type, Source, and Region – Global Forecast to 2027.” 2022.