Bulk Pharmaceutical API Sources for PROTOPIC

Bulk Pharmaceutical API Sources for PROTOPIC

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		445643
MolPort		MolPort-003-666-518
Hangzhou APIChem Technology		AC-1182
Alsachim		619
ABI Chem		AC1L9IBU
AKos Consulting & Solutions		AKOS005145901

Bulk Active Pharmaceutical Ingredient (API) Sources for PROTOPIC

Last updated: July 27, 2025

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Introduction

Protopic, known generically as tacrolimus, is a potent immunosuppressive agent primarily indicated for the treatment of atopic dermatitis and as prophylaxis in organ transplantation. The drug’s efficacy and safety profile hinge heavily on the quality and sourcing of its active pharmaceutical ingredient (API). As a complex macrolide immunosuppressant, tacrolimus requires stringent manufacturing controls and reliable supply chains. The procurement landscape for bulk tacrolimus API encompasses global pharmaceutical and chemical manufacturers, each with varying compliance standards, capacities, and reputations. This overview delineates the principal API sources for tacrolimus, emphasizing their manufacturing credentials, regulatory status, and supply stability.

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Global API Manufacturers for Tacrolimus

1. Astellas Pharma Inc. (Japan)

• Background: Astellas, the originator of tacrolimus (marketed as Prograf and Protopic), is the primary innovator and original patent holder.
• API Production: Astellas maintains comprehensive control over the manufacturing process of tacrolimus, ensuring high purity and consistent quality.
• Supply Chain Role: Despite patent expiry, Astellas often continues to supply APIs for branded products and licensed generics under strict regulatory standards.
• Credibility: As a global leader with rigorous Good Manufacturing Practice (GMP) compliance, Astellas remains a benchmark API source.

2. Hikma Pharmaceuticals (UK)

• Overview: Hikma produces tacrolimus API and finished formulations, serving multiple markets under its own brand and for third-party manufacturing.
• Manufacturing Capabilities: With GMP-certified facilities, Hikma ensures high-quality API production, adhering to stringent international standards.
• Regulatory Approval: Its API manufacturing facilities are approved by key agencies including the FDA, EMA, and MHRA, enabling broad distribution.

3. Wuxi AppTec (China)

• Profile: Wuxi AppTec is among China’s premier pharmaceutical contract manufacturing organizations (CMOs), offering tacrolimus API.
• Manufacturing Credentials: Wuxi’s facilities hold GMP certifications, with extensive quality control measures aligned with global standards.
• Market Role: While primarily serving as a CMO, Wuxi supplies APIs to various branded and generic manufacturers worldwide.
• Supply Stability: China's expanding pharmaceutical infrastructure supports Wuxi's capacity, though geopolitical factors can impact supply chain stability.

4. Jiangsu Hengrui Medicine Co., Ltd. (China)

• Overview: Hengrui has developed a robust manufacturing platform for tacrolimus API, with multiple GMP-certified facilities.
• Quality Assurance: Compliant with cGMP standards, Hengrui emphasizes stringent quality controls, ensuring API purity and consistency.
• Market Footprint: Growing presence in global markets, especially in Asia, with increasing regulatory approvals.

5. Sandoz (Novartis Division, Switzerland/India)

• Background: Sandoz specializes in generic pharmaceuticals, including tacrolimus API, leveraging Novartis’ extensive manufacturing network.
• Manufacturing Sites: Key API production facilities are situated in India and Europe, with substantial GMP compliance.
• Supply Reliability: Sandoz’s scale and quality controls support stable supply, often pivotal for generic drug markets.

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Emerging and Regional API Suppliers

1. Dr. Reddy’s Laboratories (India)

• Status: A leading Indian API manufacturer with capacity for tacrolimus synthesis.
• Quality and Compliance: Adheres to global GMP standards; recognized for cost-effective, high-quality API production.
• Market Position: Supplies both domestic and international markets, expanding its global footprint.

2. Teva Pharmaceutical Industries (Israel)

• Profile: Engages in tacrolimus API synthesis, focusing on quality and supply stability.
• Regulatory Reach: API facilities often hold approval from multiple regulatory agencies, supporting various global markets.

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Considerations in API Sourcing

• Regulatory Compliance: Ensuring suppliers hold appropriate GMP certifications (FDA, EMA, local) is essential to meet regulatory approval and quality assurance.
• Supply Chain Security: Long-term contracts with diversified manufacturers mitigate risks of shortages, geopolitical disruptions, or quality lapses.
• Quality Metrics: Purity levels >99%, low endotoxin counts, and consistent batch-to-batch reproducibility are critical parameters.
• Pricing dynamics: Cost competitiveness must be balanced against quality and regulatory compliance, particularly in procurement for generics.

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Regulatory and Quality Assurance Aspects

Sourcing tacrolimus API involves meticulous vetting of supplier certifications, inspection histories, and batch quality records. International regulatory bodies like the FDA and EMA enforce strict standards, which API manufacturers must meet to ensure proper acceptance in global markets. Contract manufacturers often undergo periodic audits, and approvals are contingent on validated manufacturing processes and thorough quality control protocols.

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Conclusion

The principal bulk sources of tacrolimus API include established pharmaceutical giants like Astellas, Hikma, and Sandoz, alongside prominent Chinese manufacturers such as Wuxi AppTec and Jiangsu Hengrui. While Astellas remains the original innovator with the highest assurance of quality, global generic manufacturers have grown increasingly reliable, expanding the availability of affordable tacrolimus API worldwide. Strategic sourcing involves balancing regulatory compliance, supply stability, and cost considerations, especially in an increasingly complex geopolitical landscape.

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Key Takeaways

• Leading global API suppliers include Astellas, Hikma, Sandoz, and Chinese firms like Wuxi AppTec and Hengrui.
• Ensuring GMP compliance and regulatory approvals are critical for quality assurance.
• Diversifying suppliers mitigates supply chain risks and supports cost-effective procurement.
• Chinese manufacturers have expanded their footprint but require rigorous validation for quality.
• Continuous monitoring and compliance audits are vital for maintaining supply chain integrity.

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FAQs

1. What are the key factors to consider when sourcing tacrolimus API?
Regulatory compliance, purity levels, manufacturing certifications, supply stability, and cost are paramount in sourcing tacrolimus API.

2. Are there any licensed generics of tacrolimus API?
Yes, multiple generic manufacturers produce tacrolimus API under license or through their own R&D, including Sandoz and Hikma, adhering to international regulatory standards.

3. How does geopolitical risk influence tacrolimus API sourcing?
Reliable supply chains from regions with political stability and strong regulatory oversight, such as Europe and Japan, mitigate risks. Over-reliance on a single region, especially China or India, can introduce supply disruptions.

4. What is the significance of GMP certification for API suppliers?
GMP certification ensures manufacturing processes meet quality standards necessary for safety, efficacy, and regulatory approval in global markets.

5. Can off-shore API manufacturers meet the required quality standards for pharmaceutical use?
Many offshore manufacturers, particularly in India and China, hold GMP certifications and are approved by major regulatory agencies, enabling them to produce high-quality APIs compliant with international standards.

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Sources:

1. [1] U.S. Food and Drug Administration (FDA) — Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
2. [2] European Medicines Agency (EMA) — Summary of Product Characteristics (SmPC) for Tacrolimus.
3. [3] Hikma Pharmaceuticals — Company Website and GMP certification reports.
4. [4] Wuxi AppTec — CMO capabilities and regulatory approvals.
5. [5] Sandoz — Product portfolio and API manufacturing quality assurances.