Bulk Pharmaceutical API Sources for STENDRA

Bulk Pharmaceutical API Sources for STENDRA

Vendor	Vendor Homepage	Vendor Sku	API Url
Finetech Industry Limited		FT-0662338
Molport		MolPort-029-944-565
AbaChemScene		CS-2644
MedChemexpress MCE		HY-18252
AKos Consulting & Solutions		AKOS024462448
BOC Sciences		330784-47-9
ChemShuttle		108376

Bulk Active Pharmaceutical Ingredient (API) Sources for Stendra (Avanafil)

Last updated: July 27, 2025

Introduction

Stendra, marketed as Avanafil, is a prescription medication used primarily for the treatment of erectile dysfunction (ED). Approved by the FDA in 2012, Avanafil's efficacy hinges on the quality and purity of its active pharmaceutical ingredient (API). The sourcing of bulk APIs is a critical component that influences regulatory compliance, manufacturing quality, and ultimately, market reliability. This article offers an in-depth analysis of global API suppliers for Avanafil, evaluating their capabilities, regulatory standing, and strategic implications for pharmaceutical companies.

Overview of Avanafil API Manufacturing

Avanafil belongs to the class of phosphodiesterase type 5 (PDE5) inhibitors, designed to increase blood flow to the penis. The API synthesis involves several complex chemical steps, demanding high purity and strict quality controls. Industry-standard synthesis routes for Avanafil are documented in patent filings and process patents, often held by patent owners or contract manufacturing organizations (CMOs).

The API manufacturing process is primarily centered in regions with mature chemical industries, notably India, China, and certain European countries, owing to cost advantages and established regulatory frameworks. Bolstering supply chain resilience requires assessment of these sources concerning their certifications, capacity, and compliance standards.

Key API Suppliers for Avanafil

1. Indian API Manufacturers

India's pharmaceutical sector dominates the API landscape due to its extensive manufacturing infrastructure, cost competitiveness, and compliance with global standards such as Good Manufacturing Practices (GMP).

• Strides Pharma Science Ltd.
  Strides has sizable API manufacturing capabilities and offers Avanafil API through its integrated platform. The company maintains WHO-GMP certifications, with validated processes aligned with international standards, making it a dependable source.

• Laurus Labs
  Laurus Labs produces a broad portfolio of APIs, including PDE5 inhibitors. Their facilities are inspected by major regulatory agencies, and they supply APIs to global markets, including Avanafil.

• Hetero Drugs Ltd.
  Hetero is known for flexible manufacturing capacity and compliance with global regulatory standards. Their API manufacturing units pass inspections from USFDA, EMA, and other agencies.

• Aurobindo Pharma
  Aurobindo's API facilities are well-established; however, their focus on Avanafil-specific API is less emphasized, but they possess the technical capacity to produce high-quality APIs.

2. Chinese API Manufacturers

China remains a significant source of bulk APIs, including PDE5 inhibitors, driven by rapid manufacturing cycles and competitive pricing.

• Sino Biopharmaceutical Limited
  With multiple GMP-certified facilities, Sino Biopharmaceutical supplies APIs to various markets. Its Chinese facilities adhere to international standards, making it a key player.

• Shanghai Pharmaceuticals Holding Co.
  State-backed and GMP-certified, the company produces a wide array of APIs, including those used in ED treatments, with robust export capabilities.

• North China Pharmaceutical Group Corporation (NCPC)
  Noted for large-scale production, NCPC offers competitive API options, with adherence to regulatory standards conducive to export.

3. European and US-Based API Suppliers

Manufacturers in Europe and the US tend to focus on specialty APIs with stringent regulatory oversight.

• Boehringer Ingelheim
  Boehringer has advanced API production lines and adheres to strict quality standards, although specific information on Avanafil API remains limited, given patent and proprietary considerations.

• Cambridge Major Laboratories (now part of Campside Pharma)
  Specializes in GMP-grade APIs, with capabilities to produce novel or complex compounds like Avanafil, ensuring compliance with stringent US and EMA regulations.

4. Contract Manufacturing Organizations (CMOs)

CMOs play a pivotal role, especially for smaller biotech firms or for companies seeking to outsource production.

• Thermo Fisher Scientific
  Offers API development and manufacturing services compliant with cGMP standards, providing flexible scale-up options for Avanafil API.

• Lonza Group
  Known for high-quality pharmaceutical ingredients, Lonza's facilities can accommodate complex molecule synthesis, including PDE5 inhibitors, with regulatory compliance.

• Samsung Biologics
  Although more prominent in biologics, Samsung extends services into chemical synthesis, offering scalable API manufacturing options.

Assessment Criteria for API Sources

When evaluating API suppliers, pharmaceutical companies must consider:

• Regulatory Compliance: GMP, FDA, EMA approvals, and inspections.
• Manufacturing Capacity & Scalability: Ability to meet demand fluctuations.
• Quality Assurance: Batch consistency, purity (>99%), and impurity profiles.
• Certifications: ISO, WHO-GMP, and other relevant quality standards.
• Supply Chain Reliability: Delivery timeliness, geopolitical stability, and risk mitigation.
• Pricing & Terms: Cost competitiveness balanced with quality assurance.

Regulatory and Quality Considerations

Selecting a dependable API supplier for Avanafil necessitates rigorous due diligence aligned with current regulations. The USFDA, EMA, and other national authorities require that APIs adhere to strict GMP standards, with transparent documentation, stability data, and batch traceability. Suppliers with recent inspection records and validated manufacturing processes carry a higher assurance level, reducing regulatory hurdles for downstream marketing.

Strategic Implications for Market Participants

• Diversification of Supply Chain: Relying on multiple sources, particularly from different regions, mitigates geopolitical and supply chain risks.
• Priority on Quality Certifications: Suppliers with WHO-GMP, USFDA, or EMA approvals streamline regulatory approval processes.
• Cost-Quality Balance: While India and China offer cost-effective options, establishing partnerships with European or US-based suppliers can enhance compliance and market acceptance.
• Technology Transfer Capabilities: Engaging with suppliers capable of technology transfer ensures seamless scaling and quality consistency.

Conclusion

The sourcing landscape for Avanafil API is robust, with well-established manufacturers across India, China, Europe, and North America. The optimal supplier selection hinges on aligning regulatory compliance, quality standards, capacity, and cost considerations. Strategic procurement, combined with diligent supplier qualification, guarantees a reliable supply chain that can meet global market demands while maintaining high-quality standards.

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Key Takeaways

• Indian and Chinese manufacturers dominate the global API supply chain for Avanafil, offering cost-effective and scalable options.
• Suppliers with current GMP certifications and recent inspections provide higher assurance of quality compliance.
• Diversifying API sources across regions mitigates geopolitical and supply chain risks.
• Regulatory alignment is crucial; partnering with suppliers possessing USFDA or EMA approval expedites market entry.
• Contract manufacturing organizations (CMOs) offer flexible, scalable APIs, advantageous for small-to-mid-sized firms.

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FAQs

1. What are the primary factors influencing API sourcing decisions for Avanafil?
Regulatory compliance, manufacturing capacity, quality assurance, supply chain reliability, certifications, and cost are critical factors. Companies prioritize suppliers with proven GMP records, validated processes, and scalable facilities.

2. Are there any US-based API manufacturers for Avanafil?
While US-based API manufacturing exists, few specialize specifically in Avanafil due to patent constraints. Companies like Cambridge Major Laboratories, now part of Campside Pharma, provide high-quality APIs with USFDA compliance, making them suitable options.

3. How does the regulatory environment affect API supplier selection?
Regulatory approvals such as GMP certifications, recent inspection reports, and adherence to international standards influence supplier reliability. Suppliers with USFDA or EMA inspections simplify compliance for marketed products.

4. What risks are associated with sourcing APIs from China and India?
Potential risks include quality variability, intellectual property concerns, supply chain disruptions, and geopolitical issues. Rigorous qualification and auditing mitigate these risks.

5. Can API manufacturing processes for Avanafil be transferred from one supplier to another?
Yes, with proper technology transfer and validation, API processes can be transferred. However, this requires comprehensive validation to ensure product quality and consistency across suppliers.

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Sources

[1] U.S. Food and Drug Administration. "Approved Drug Products with Therapeutic Equivalence Evaluations." 2022 Edition.
[2] European Medicines Agency. "Guidelines on Good Manufacturing Practice." 2021.
[3] Patent filings related to Avanafil synthesis processes, available through WIPO PATENTSCOPE and EPO databases.
[4] Industry reports on global API manufacturing capacity, IQVIA, 2022.
[5] Company disclosures and regulatory filings from Strides, Laurus, Hetero, and other key manufacturers.