Bulk Pharmaceutical API Sources for DAKLINZA

Bulk Pharmaceutical API Sources for DAKLINZA

Vendor	Vendor Homepage	Vendor Sku	API Url
MedChemexpress MCE		HY-10465
AbaChemScene		CS-0270
Axon Medchem		2093
TargetMol		T1786
Hangzhou APIChem Technology		AC-28423

Bulk Active Pharmaceutical Ingredient (API) Sources for Daklinza (Daclatasvir)

Last updated: July 30, 2025

Introduction

Daclatasvir, marketed as Daklinza, is an antiviral agent developed by Bristol-Myers Squibb (BMS) used in the treatment of hepatitis C virus (HCV) infections. Its mechanism involves inhibiting the NS5A protein, crucial for HCV replication, thereby demonstrating potent antiviral activity across multiple genotypes. As a critical component in pharmaceutical manufacturing, the procurement of bulk active pharmaceutical ingredient (API) sources for Daclatasvir is vital for ensuring supply chain stability, cost-effectiveness, and regulatory compliance for pharmaceutical companies worldwide.

This article offers an in-depth analysis of potential API suppliers, covering licensed manufacturers, contract manufacturing organizations (CMOs), emerging players, and considerations for sourcing Daclatasvir API.

Regulatory Landscape and Patent Considerations

Before exploring API sources, it is imperative to recognize the patent status and regulatory environment governing Daclatasvir. Bristol-Myers Squibb holds the original patent rights, although patent expirations or licensing agreements can influence manufacturing agreements and availability. Additionally, the approval status across countries can impact the acceptability of APIs from different regions [1].

Authorized API Manufacturers for Daklinza (Daclatasvir)

1. Bristol-Myers Squibb (BMS)

As the originator, BMS retains manufacturing capabilities for Daclatasvir API. Their facilities are compliant with Good Manufacturing Practices (GMP), and they supply APIs mainly for internal use and licensed partners. BMS's technology ensures high purity standards, but direct access for external buyers may be limited, often requiring licensing or technology transfer agreements.

2. Contract Manufacturing Organizations (CMOs)

Several CMOs possess the technical capacity and GMP compliance to produce Daclatasvir API, either under licensing agreements with BMS or through independent synthesis routes. Key players include:

• Patheon (Thermo Fisher Scientific): Known for flexible API production with extensive experience in complex molecules. Their facilities in North America and Europe can produce Daclatasvir API following strict quality standards.

• Samsung Biologics: A rapidly expanding CMO with advanced synthesis capabilities for antiviral APIs, including negotiation for manufacturing Daclatasvir.

• Liomont (Mexican pharmaceutical CMO): Recognized for synthesizing antiviral APIs, with potential GMP-compliant Daclatasvir production capabilities.

• VIRAMED Biotech: Specializes in complex API manufacturing within India, with potential expertise in HCV antiviral compounds.

3. Indian API Manufacturers

India's API industry is robust, particularly in antivirals, driven by pharmaceutical giants and specialized manufacturers. Some notable companies potentially capable of Daclatasvir API production include:

• Ursol Healthcare: With experience in HCV antivirals, they may be capable of scalable synthesis.

• Hetero Labs: Known for producing antiviral APIs, with existing infrastructure for complex molecule synthesis.

• Cadila Healthcare: Active in API manufacturing for HCV therapies; could offer Daclatasvir API volume.

4. Chinese API Manufacturers

China's API sector is a significant global supplier, with numerous manufacturers capable of producing Daclatasvir, either directly or via custom synthesis. Key entities include:

• WuXi AppTec: Offers comprehensive API development and manufacturing services, including complex antiviral APIs.

• North China Pharmaceutical Group Corporation (NCPC): Has extensive experience in antiviral APIs and may serve as a source for Daclatasvir.

• Shanghai Acebright Pharmaceuticals: Known for antiviral API synthesis, potentially capable of providing Daclatasvir.

Emerging and Independent API Manufacturers

Several smaller or emerging manufacturers leverage advanced synthetic routes, optimizing cost and turnaround times. Their capabilities are validated through certifications, client references, and quality assurance audits. Examples include:

• Bennett Pharmaceuticals: An Indian API producer with antiviral synthesis expertise.

• Hunan Dongting Pharmaceutical: A Chinese company with potential Daclatasvir manufacturing capacity.

Sourcing Considerations

Quality and Compliance

Ensuring APIs meet USP, EP, or ICH guidelines is critical. Manufacturers with current GMP certification, rigorous quality control, and transparent documentation are preferred. Regulatory compliance directly influences product approval and market access.

Cost and Lead Times

Although price competitiveness is important, rapid supply and reliable quality should take precedence. Established large-scale manufacturers typically offer better predictability, while emerging manufacturers may provide cost advantages with appropriate due diligence.

Intellectual Property and Licensing

Given the patent status, access to Daclatasvir API from licensed manufacturers or under licensing agreements is often necessary, especially in jurisdictions where patent enforcement is active [2].

Supply Chain Risks

Diversification of suppliers across regions reduces geopolitical and logistical risks. Multi-source sourcing strategies mitigate potential disruptions.

Future Trends in API Sourcing for Daklinza

The expiration of patents in certain markets and technological advancements in synthesis methodologies will likely enable broader access to Daclatasvir API. Development of biosynthetic routes could further diversify supply options. Additionally, increased capacity in emerging markets like India and China will enhance availability and reduce prices.

Regulatory and Quality Assurance

Pharmaceutical companies must conduct thorough audits to verify GMP compliance, review Certificates of Analysis (CoA), and ensure API traceability. Establishing long-term supply agreements with reputable manufacturers is advisable to secure quality and consistency.

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Key Takeaways

• Multiple sources exist for Daclatasvir API, primarily from BMS, CMOs, and manufacturers in India and China.

• Regulatory compliance and GMP certification are critical factors in sourcing; validated suppliers reduce compliance risk.

• Patents and licensing influence access; secure supply from authorized manufacturers or under license agreements.

• Indian and Chinese API manufacturers offer scalable and cost-effective options, with an increasing number of GMP-certified facilities.

• Supply chain resilience requires diversification across regions and suppliers, along with rigorous quality assurance processes.

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FAQs

1. Can I source Daclatasvir API directly from Bristol-Myers Squibb?
Typically, BMS supplies Daclatasvir API through licensing agreements; direct purchase for external manufacturing is limited and requires formal licensing or partnership arrangements.

2. Are there approved generic sources of Daclatasvir API?
Generic manufacturers in India and China with GMP certification can supply Daclatasvir API, provided they hold appropriate licensing rights and meet regulatory standards.

3. What should I verify when selecting an API manufacturer for Daclatasvir?
Ensure GMP compliance, current Certificates of Analysis, validation of synthetic routes, capacity to meet demand, and alignment with regulatory specifications.

4. How do patent restrictions affect sourcing Daclatasvir API?
Patent rights can restrict manufacturing or importation in certain territories. Sourcing from licensed manufacturers or post-patent expiry is advisable to avoid infringement issues.

5. What are the cost implications of sourcing Daclatasvir API from different regions?
Indian and Chinese manufacturers typically offer lower costs due to scale and efficiency, but factors like shipping, quality assurance, and regulatory costs influence overall affordability.

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References

[1] Bristol-Myers Squibb. (2022). Daklinza (Daclatasvir) – Prescribing Information.
[2] World Intellectual Property Organization. (2021). Patent status of Daclatasvir.